Prevention of Severe Postoperative Pain after Breast Surgery Using Opioid-Sparing Analgesia with Intraoperative and Drain-Based Ropivacaine Infiltration: A Prospective Observational Study

Abstract

Background and Aim

Breast surgery is frequently associated with high postoperative pain, which if not adequately managed can delay recovery and increase the risk of chronic postsurgical pain. This study evaluated whether perioperative opioid application and/or incisional infiltration with long-acting local anaesthetics can improve postoperative pain control as part of an effective preventive strategy.

Study Design and Methods

A total of 536 consecutive patients undergoing breast surgery at Jena University Hospital were prospectively evaluated on the first postoperative day using a standardized pain questionnaire as part of the QUIPS (Quality Improvement in Postoperative Pain Management) project. Analgesic strategies were introduced sequentially in addition to the standard postoperative pain management (group A, first 9 months), addition of prophylactic oxycodone (group B, 17 months), combined oxycodone and wound infiltration with ropivacaine (group D, 4 months), and finally, ropivacaine alone (group C, 6 months).

Results

All three intervention groups showed significant improvements over standard care, with more patients pain-free at 24 h (group A: 9.5%, B: 18.5%, C: 16.3%, D: 25.6%; p = 0.01), fewer requiring opioids on demand (A: 26.5%, B: 15.9%, C: 4.1%, D: 4.7%; p < 0.05), and a significantly delayed first opioid request. The incidence of nausea and vomiting was significantly lower in the ropivacaine-only group compared to other regimens (p = 0.03). Ropivacaine infiltration alone (group C) was associated with the fewest opioid-related side effects.

Conclusion

Intraoperative and drain-based ropivacaine wound infiltration, alone or in combination with pre-emptive oxycodone, effectively reduced acute postoperative pain and opioid requirements after breast surgery, while reducing opioid-related side effects like nausea and vomiting. As part of a multimodal, opioid-sparing strategy, this technique demonstrated favourable patient-reported outcomes and may contribute to faster recovery, fewer side effects, and improved patient-reported satisfaction. These findings support the clinical relevance of preventive local anaesthetic techniques in breast surgery.

Introduction

Breast surgery techniques have been widely developed over the years to become safer and less invasive achieving good aesthetic results. Acute postoperative pain after these surgeries seems to be less severe if treated with NSAIDs and opioids. But using opioids for postoperative pain treatment has been associated with some relevant adverse effects, which could affect the patient recovery process (e.g., nausea, constipation, and dizziness) and strongly affects the patient satisfaction [1]. Nevertheless, opioids on postoperative settings are usually applied on demand. Due to this practice, it is not unlikely that an application could be delayed or insufficient depending on intern awareness, process organization, or personal attitudes of ward staff. Some authors postulate that analgesic techniques like prophylactic opioid application or wound infiltration, where patients are not depending on demand medication, could increase quality of pain management [2]. In a meta-analysis of 33 studies representing 53,362 patients, Yang and colleagues identified significant predictors for high acute postoperative pain following breast surgery, with preoperative anxiety, younger age, higher BMI, and more extensive surgery being the strongest risk factors. These findings underline the importance of proactive analgesic strategies, such as those evaluated in our study – prophylactic opioids and incisional infiltration of local anaesthetics – to specifically target and mitigate acute postoperative pain in patients [3]. Minimizing the experienced postoperative pain has become a crucial objective as it is associated with faster recovery and therefore an earlier discharge as well as reduced readmissions after discharge [1, 4]. Evaluation of pain experience needs to consider multiple clinical and nonclinical aspects of patient care which are not easy to evaluate under strict conditions of randomized controlled trials (RCTs) assessing only values like vital parameters and dosage of medication. In the last years, we can find an increasing interest in so-called real-world evidence, since it has been observed that therapies that have been assumed effective in RCTs fail to show expected results after application under real care conditions [5, 6]. Using patient-reported outcomes (PROs) in form of questionnaires and scales describing patient experience as well as data extracted from high-volume registers can help evaluate introduced strategies under daily conditions and try to close this gap [7, 8]. While non-surgical site pain is increasingly recognized as a relevant postoperative burden in breast cancer surgery [9], this aspect was not assessed in our study, which focused on surgical site-specific acute postoperative pain and its prevention.

The aim of this study was to evaluate the effectiveness of three different preventive strategies of perioperative pain management on improvement of analgesic care using PROs like postoperative pain intensity and demand for postoperative pain medication as primary endpoints. Secondary endpoints were evaluated such as satisfaction with pain management, wish for more pain medication, side effects of pain medication like nausea or vomiting, and pain-related impairment of daily activities like sleep, mood, movement, breathing, and tiredness. We hypothesized that incisional infiltration of ropivacaine and/or pre-emptive opioid can improve postoperative pain experience.

Methods

This study was approved by the Ethics Committee of Jena University Hospital (2722-12/09). Between January 2011 and December 2013, consecutive female patients (>18 years) undergoing breast surgery at the Department of Gynecology and Reproductive Medicine, Jena University Hospital – which has been certified and regularly quality assured as an Interdisciplinary Breast Center by the German Cancer Society and the German Society of Senology since 2005 – provided informed consent and were prospectively evaluated. Exclusion criteria were contraindication or allergy to local anaesthetics, refusal of treatment, refusal of participation in the data assessment, day care operations, or concurrent participation in another clinical study. Since intervention was integrated as standard operating procedure into our quality assurance (DIN EN ISO 9001), patients were not informed about the participation in this comparative study. Surgical procedures were categorized into four groups as follows: “reconstructive surgery” included TRAM or DIEP flap procedures or immediate reconstruction with an implant; “breast surgeries alone” encompassed larger biopsies and lumpectomies; “breast surgery and axilla” referred to breast-conserving procedures or reduction mammoplasty combined with sentinel node biopsy or axillary dissection levels 1 and 2; and “axilla” included level 1 and 2 dissections and level 3 when necessary. From 2005 to 2023, our department served as a referral centre for reconstructive breast surgery in Thuringia. Although DIEP and TRAM flaps were routinely performed with local infiltration, these patients were less frequently included in the QUIPS registry, often due to the use of continuous pain catheters (perfusors), which precluded standardized pain assessment under the QUIPS protocol.

Analgesic strategies were introduced and evaluated sequentially to assess their preventive effects on severe acute postoperative pain. Initially, patients received standard pain management (control group A, metamizole and piritramide on demand). Prophylactic application of oxycodone und naloxone was introduced from October 2011 to June 2013 (group B). Intraoperative application of wound infiltration using ropivacaine was implemented in March 2013 (group C) and maintained until the end of study. Between March and June 2013, the combination of prophylactic oxycodone/naloxone and ropivacaine infiltration was evaluated (group D). All strategies were integrated into standard operating procedures after comprehensive staff training.

An external research assistant, blinded to the interventions, collected demographic and clinical data, and administered a validated pain questionnaire (Quality Improvement in Postoperative Pain Management, QUIPS) and visited all patients 24 h post-surgery to collect demographical, clinical, and outcome data. Patients were instructed and asked to anonymously fill in the questionnaire. This questionnaire was developed and validated [10, 11] by the pain unit of the Jena University Hospital as a part of a national, multicentre interdisciplinary project for improvement of postoperative pain management (https://www.quips-projekt.de/quips/, last visited on March 21, 2025). This questionnaire was divided into different sections dealing with pain intensity, functional impairment, side effects of pain treatment, and global assessment of postoperative pain management, answered by the patient (Table 1). Patients were instructed to use a Numeric Rating Scale (NRS) from 0 to 10 for assessing pain intensity.

Table 1.

Overview of outcome measures on the questionnaire

Outcome measure	Scale
Pain on ambulation/movement	NRS 0–10a
Maximum pain intensity since surgery	NRS 0–10a
Minimum pain intensity since surgery	NRS 0–10a
Is pain interfering with your mobility or movement?	Yes/no
Are you experiencing pain when you cough or breathe deeply?	Yes/no
Were you woken up by pain last night?	Yes/no
Is pain interfering with your mood?	Yes/no
Have you felt very tired since your surgery?	Yes/no
Have you felt nausea since your surgery?	Yes/no
Have you felt dizzy since surgery?	Yes/no
Would you have liked to have received more pain medication?	Yes/no
How satisfied are you with your pain treatment since surgery?	NRS 0–10b

^aNumeric Rating Scale (NRS) for pain intensity: 0 = no pain, 10 = most intense pain imaginable.

^bNRS for satisfaction: 0 = very unsatisfied, 10 = very satisfied.

Members of the surgical or ward team were excluded from data collection or patient questioning. To ensure standardized data collection, written guidelines and training were provided to study personnel. All data were collected and sent to a central internet database of the QUIPS project [12].

A standard anaesthetic technique was employed in all procedures. Midazolam was used as oral premedication. General anaesthetic was induced with propofol and sufentanil. Rocuronium was given to facilitate intubation and control ventilation. Anaesthesia was maintained using sevoflurane. During the postoperative period, all patients, independent of group allocation, received standardized analgesic medication (1 g metamizole every 6 h and nurse controlled intravenous 1.5–3 mg piritramide bolus on demand). If patients required more than 30 mg piritramide in 4 h, a pain specialist evaluated the patient and analgesic medication was individually adapted. Depending on the quality and intensity of pain, paracetamol, ibuprofen, or other opioids were additionally administered on demand. Prophylactic oxycodone (mixed-dose combination tablet oxycodone/naloxone in a 2:1 ratio [Targin^® 10 mg/5 mg, Mundipharma GmbH]) was given orally every 12 h, starting 12 h before surgery, continuing through the second postoperative day, or longer if needed.

For ropivacaine infiltration, wound edges were infiltrated following a standardized technique with 20 mL ropivacaine 0.75% (Ropivacaine^® Fresenius Kabi GmbH, Bad Homburg, Germany) prior to skin closure, followed by an additional 10 mL instilled via the drainage after closure. The drainage system remained closed for 30 min after the operation to avoid premature loss of the solution. Administration of ropivacaine was adapted to wound surface and depths of the surgical field. The entire surgical team was instructed and trained in the application technique to guarantee uniformity of the procedure.

Statistical analysis included Mann-Whitney U test (for ordinal variables: pain intensity and satisfaction NRS), t tests (for continuous variables: dosage of rescue medication, time to first rescue medication), chi-squared or Fisher’s exact test (for nominal variables: nausea, vomiting, etc.). Statistical significance was considered if p was < 0.05. Statistical analysis was performed using SPSS version 20.0 (SPSS Inc., Chicago, IL, USA). For subgroup analysis of risk factors, chi-square was performed for distribution through all groups. When significance occurred, it was assumed that at least one group stochastically dominated another. Subsequent testing was accomplished for pairwise comparison between each group.

Results

A total of 623 patients were screened during the different study periods who met the inclusion criteria. Thirty-nine women declined their participation in the study, and 48 were excluded from statistical comparison due to predefined reasons (reasons for exclusion given in Fig. 1). Ultimately, 536 patients were observed prospectively. As already described depending on the period of their surgery, patients had different perioperative pain managements. In total, four groups were created: 211 patients receiving standard therapy were defined as the control arm (group A). Two hundred thirty-three patients received standard therapy plus prophylactic oxycodone/naloxone (group B). Forty-nine patients received wound infiltration with ropivacaine added to standard care without prophylactic oxycodone (group C). A third group of 43 patients were treated in the overlapping period receiving both therapies added to standard care (group D). These four groups resulted to be similarly balanced and comparable in terms of demographic and surgical characteristics, despite the different group size (Table 2). No difference could be found in the distribution of type of surgery between the four groups (p = 0.37).

Fig. 1.

Selection process of included cases.

Table 2.

Patient characteristics

​	Group A, n = 211	Group B, n = 233	Group C, n = 49	Group D, n = 43	p value
Age, mean (SD), years	58.3 (14.6)	56.4 (13.1)	54.4 (19.2)	55.2 (15.1)	0.18a
OP duration, mean (SD), min	84.7 (65.5)	89.10 (76.2)	72.5 (34.2)	111.6 (86.7)	0.16a
Type of surgery, n (%)	​	​	​	​	0.37b
Reconstructive surgery	37 (17.5)	27 (11.6)	4 (8.2)	9 (20.9)	​
Breast surgery + axilla	94 (44.5)	118 (50.6)	28 (57.1)	20 (46.5)	​
Breast surgery alone	74 (35.1)	86 (36.9)	16 (32.7)	13 (30.2)	​
Axilla alone	6 (2.8)	2 (0.9)	1 (2)	1 (2.3)	​
Chronic pain, n (%)	50 (23.7)	39 (16.7)	11 (22.4)	9 (20.9)	0.32b

Group A: standard therapy, group B: prophylactic oxycodone, group C: intraoperative ropivacaine; group D: prophylactic oxycodone combined with intraoperative ropivacaine.

^aCalculated using Mann-Whitney U test.

^bCalculated using chi-squared test.

Maximal pain after surgery was reduced from 4.2 points of NRS in group A to 3.6 in groups B and C and to 3.5 in group D (p = 0.05). This difference turned out to be statistically significant between the comparison of group A with group B (p = 0.01) (Fig. 2). Movement related pain intensity and minimal pain intensity since operation was noted to be similar between the groups (Fig. 2; Table 3). The percentage of patients stating to be pain-free at 24 h after surgery was in group D with 25.6% significantly higher than in the other groups (groups A, B, and C with 9.5%, 18.5%, and 16.3%, respectively, p < 0.01 for each pairwise comparison with group D).

Fig. 2.

Pain intensities compared in group A–D. Comparison between the groups for the variables NRS max (maximal pain intensity), NRS move (pain intensity while movement), and NRS min (minimal pain intensity) since surgery. Calculated using Mann-Whitney U test, *p = 0.01. Group A: standard therapy, group B: prophylactic oxycodone, group C: intraoperative ropivacaine, group D: prophylactic oxycodone combined with intraoperative ropivacaine.

Table 3.

Side effects of pain medication and impairment due to pain

​	Group A, n (%)	Group B, n (%)	Group C, n (%)	Group D, n (%)	p value
Awake due to pain	52 (24.6)	52 (22.3)	15 (30.6)	6 (14)	0.27
Tiredness	100 (47.4)	119 (51.1)	17 (34.7)	21 (48.8)	0.22
Impaired mobilization	109 (51.7)	115 (49.4)	21 (42.9)	18 (41.9)	0.53
Bad mood	33 (15.6)	27 (11.6)	5 (10.2)	4 (9.3)	0.46
Impaired deep breath	35 (16.6)	26 (11.2)	7 (14.3)	9 (20.9)	0.23
Nausea and vomiting	29 (13.7)	47 (20.2)	3 (6.1)	10 (23.3)	0.03
Free of pain 24 h after surgery	20 (9.5)	43 (18.5)	8 (16.3)	11 (25.6)	0.01

Calculated using chi-squared test.

Group A: standard therapy, group B: prophylactic oxycodone, group C: intraoperative ropivacaine, group D: prophylactic oxycodone combined with intraoperative ropivacaine.

The use of opioid medication on demand was meaningfully reduced in all three intervention groups. This reduction was statistically significant when comparing each of the three groups (groups B, C, and D) with the standard therapy (group A). In group A, 26.5% of the patients (56 patients) demanded extra opioids for pain release. The opioid requirement of the other groups was 15.9% (37 patients) in group B, 4.1% (2 patients) in group C, and 4.7% (2 patients) in the combination arm (p < 0.01 for each comparison with group A) (Fig. 3). Regarding the difference between interventions both groups receiving LAs (groups C and D) showed the lowest opioid requirements, statistical significance (p < 0.01) was also achieved for this comparison (group B vs. group C and B vs. D). Demand analgesic medication was also administered significantly later in the three therapy groups when compared to standard arm (Fig. 4). Group A demanded the first opioid 4.7 (±4.3) hours after surgery, while groups B, C, and D asked for opioids for the first time 5.7 (±3.2), 7.2 (±4.3), and 6.3 (±3.3) hours after surgery, respectively (p < 0.01 for each comparison with group A). Also, the difference between group B and C could be demonstrated statistically significant (p = 0.03), whereas group C was satisfied longer without additional medication. As initially defined, an evaluation of secondary endpoints such as satisfaction with pain management, side effects of pain medication like nausea or vomiting and pain-related impairment of daily activities like sleep, mood, movement, breathing, and tiredness was performed.

Fig. 3.

Use of opioids on demand. Calculated using chi-squared test, *p < 0.05. Group A: standard therapy, group B: prophylactic oxycodone, group C: intraoperative ropivacaine, group D: prophylactic oxycodone combined with intraoperative ropivacaine.

Fig. 4.

Time in h until first medication on demand. Calculated using Mann-Whitney U test, *p < 0.05. Group A: standard therapy, group B: prophylactic oxycodone, group C: intraoperative ropivacaine, group D: prophylactic oxycodone combined with intraoperative ropivacaine.

Regarding satisfaction with pain management or wish for more pain medication no differences were found between the four groups. Furthermore, no significant difference was seen for possible adverse effects regarding mobilization, mood, breathing, coughing, tiredness, sleeplessness due to pain (Table 3). Whereas the rate of nausea and vomiting was significantly lower in group C. Only 6.1% of the women (3 patients) in the ropivacaine-alone group complained about postoperative nausea, while 13.7% (29 patients) of group A, 20.2% (47 patients) of group B, and 23.3% (10 patients) of group D suffered this symptom after surgery. Pairwise comparison showed significantly higher levels of nausea in both groups receiving prophylactic oxycodone (group B and D). Patients of group C demonstrated significantly lower nausea levels compared with all other groups (p < 0.05 for each comparison). Concerning the other variables of the QUIPS questionnaire, no further significant results could be seen.

Discussion

In this study, we evaluated two analgesic strategies aimed at preventing severe acute postoperative pain after breast surgery, under standard conditions in a high-volume centre from a patient perspective. To our knowledge, this is the largest cohort of patients analysed using patient-reported outcomes (PROs) for postoperative pain management in breast surgery, enabled by QUIPS – part of PAIN-OUT, the largest acute pain registry worldwide, which allows standardized pain assessment and international benchmarking. All introduced interventions significantly prevented severe acute pain and reduced opioid consumption compared to former standard management. Notably, the group receiving prophylactic opioids experienced increased nausea and vomiting. Therefore, wound infiltration with ropivacaine alone emerged as the preferred preventive analgesic approach.

The opioid-sparing effects of local anaesthetics, especially ropivacaine, have been well documented in various surgeries [13, 14]. A recent meta-analysis of RCTs regarding ropivacaine application in uterosacral ligaments during uterine surgery showed no significant difference in postoperative pain level but a significant decrease of postoperative opioid consumption in the ropivacaine group [15]. Similar findings to our results showed a double-blinded RCT evaluating efficacy of a superior hypogastric plexus nerve block through infiltration of 10 mL 0.75% ropivacaine into the retroperitoneal space overlying the superior hypogastric plexus during minimal invasive hysterectomy or myomectomy. Both parameters, pain level throughout the first 24 h after surgery and rescue opioid demand, were significantly lower in the group with ropivacaine block [16]. In contrast, our earlier experience indicated that ropivacaine-based nerve blocks were ineffective for severe ischaemic pain after uterine artery embolization, where epidural analgesia proved to be superior [17]. Positive outcomes from ropivacaine wound infiltration were also demonstrated by another study for laparoscopic gynaecological surgery [18].

In the present study, ropivacaine infiltration alone effectively prevented severe acute postoperative pain, extending the opioid-free interval by 2.5 h and reducing the absolute demand of opioids from 26.5% to 4.7% of the patients compared to controls. More than one-quarter of patients receiving combined wound infiltration and opioids were pain-free at 24 h. These results underline the substantial preventive impact of ropivacaine infiltration, significantly reducing acute severe pain, opioid demand, and opioid-related side effects compared to the control group. The observed pain scores are in line with previous real-world data in similar surgical settings [19], highlighting the ongoing need for effective multimodal analgesia.

Comparable preventive benefits from ropivacaine wound infiltration have been reported for breast surgeries by Campbell et al. [20] where a notable opioid-sparing effect was observed, although in a smaller patient cohort (n = 90). Furthermore, a double-blind randomized study including 236 patients with local ropivacaine wound infiltration prolonged the pain-free time by 90 min compared to controls [21]. In a meta-analysis for wound infiltration with ropivacaine or bupivacaine in breast cancer surgeries, a reduction of pain 2 h after surgery could be seen, though without demonstrating an overall reduction in analgesic demand [22]. Our findings highlight the comprehensive preventive impact of ropivacaine infiltration in reducing acute postoperative pain, opioid requirements, and opioid-related side effects, but also the pain levels after 24 h, compared to standard analgesic approaches. Importantly, regional anaesthesia techniques have been associated with reductions in chronic postoperative pain, defined as persistent pain 3 months post-surgery, as indicated by a Cochrane Review which found moderate-quality evidence for thoracotomy, breast cancer surgery, and caesarean sections. Such findings suggest the potential long-term preventive benefits of using local anaesthetic techniques during surgery [23].

A recent RCT on laparoscopic cholecystectomies reported significantly less postoperative pain and opioid demand when intravenous nalbuphine was combined with incisional ropivacaine (10 mL, 0.5%) compared to ropivacaine alone [24]. In contrast, our study did not show additional benefits of prophylactic opioids when combined with local anaesthetics. A potential explanation for this discrepancy might be the substantially higher ropivacaine dose (225 mg total) in our protocol. Malhotra et al. [25], who compared two doses of bupivacaine (50 mg vs. 100 mg) given at the end of laparoscopy, have previously emphasized the importance of dose, showing greater and prolonged analgesic effects using higher doses.

Long-acting local anaesthetics such as ropivacaine, levobupivacaine, and bupivacaine generally demonstrate superior analgesic effects compared to short-acting anaesthetics like lidocaine [26–28]. Parsanezhad et al. [26] showed in an RCT significantly better postoperative pain reduction with long-acting bupivacaine compared to lidocaine. Fayman et al. [29] postulate no difference of effectiveness between the two long-lasting LAs bupivacaine and ropivacaine but emphasized ropivacaine’s better safety profile, with fewer cardiovascular and neurological adverse effects. No local or systemic side effects related to ropivacaine administration were observed in this cohort. This aligns with its known safety profile in the concentrations used for wound infiltration, especially as known risk factors for systemic toxicity – such as intravascular injection or impaired metabolism – were not applicable to the route, dose, and patient population studied [30]. Due to this advantageous safety profile and substantial analgesic efficacy confirmed by multiple studies [31–33], ropivacaine remains our recommended choice for wound infiltration.

In our study, surgeries involving combined therapy (ropivacaine and opioids) were 23–39 min longer compared to the other groups. Longer surgery duration is commonly associated with increased postoperative pain, with severe pain rising notably after procedures exceeding 90 or 120 min, severe pain was expressed in even 20% [34]. Remarkably, our data demonstrated significantly reduced postoperative pain and delayed analgesic demand, despite longer surgery duration. This underscores the strong preventive analgesic benefit of the multimodal approach in group D.

Continuous postoperative wound infiltration with ropivacaine (0.8%, 2 mL/h) using a wound catheter after anterior lumbar interbody fusion surgeries has shown substantial analgesic benefits, significantly reducing pain and opioid requirements during the first 48 h compared to standard patient-controlled analgesia [35]. Although pain differences diminished after 1 week, patient satisfaction remained significantly higher in those receiving continuous local anaesthetic infusion.

Infiltration of local anaesthetics via surgical drains has also been demonstrated effective for postoperative analgesia. Wang et al. [36] observed in an RCT of 74 patients reduced pain scores using ropivacaine infiltrated via drainage catheters post-breast surgery. Also, Khpal et al. [37] showed significantly lower pain scores with levobupivacaine administered via surgical drain 3 and 12 h after axillary dissection. This positive effect lasted up to 24 h postoperatively. Repetitive doses of LA in surgical drains suggest being an effective method with low side effect profile to further enhance postoperative pain management.

Adjunctive dexamethasone significantly enhances ropivacaine’s analgesic effects by addressing inflammatory pain mechanisms. In paediatric craniotomy patients, adding dexamethasone prolonged the median opioid-free period to 24 h compared to 8.5 h with ropivacaine alone [38]. Similarly, dexamethasone addition to ropivacaine in knee arthroplasty reduced pain scores, morphine consumption, and levels of inflammatory biomarkers (C-reactive protein, IL-6) [39], suggesting a promising role for corticosteroid adjuncts in preventive postoperative analgesia. While local infiltration techniques such as those evaluated are widely applied in clinical practice, their formal inclusion in national and international guidelines remains limited, in part due to the lack of large-scale RCTs.

Limitations

This prospective observational study evaluated consecutive patient groups to integrate analgesic strategies into clinical routine, potentially introducing selection bias. This study was not blinded. However, an independent trained study assistant conducted patient interactions and data collection, reducing external bias. Uneven group sizes – particularly fewer patients in groups C and D compared to groups A and B – may limit statistical interpretation. Additionally, potential influencing factors such as pre-existing conditions or socioeconomic status which could affect perceived pain levels were not systematically assessed.

Preoperative pain scores were not recorded, as this parameter was not part of the standardized QUIPS protocol used in this study. However, the presence of chronic pain was documented at baseline and found to be similar across all groups (see Table 1), helping reduce potential bias from pre-existing pain conditions. Furthermore, pain intensity was assessed only once at 24 h postoperatively, in accordance with the QUIPS protocol, which is focused on acute postoperative pain rather than longer term outcomes. Although data collection was completed between 2011 and 2013, publication was deferred to allow for integration into routine care and broader institutional learning. The study was embedded in the university-wide PAIN-OUT/QUIPS initiative, which was active over a longer period, and full evaluation for publication was initiated after the conclusion of the local project phase. Following this study, the analgesic multimodal strategies – particularly intraoperative and drain-based ropivacaine infiltration – have since then become our institutional standard, demonstrating sustained effectiveness and ongoing positive feedback from visiting clinicians adopting this preventive approach.

Conclusion

Breast surgery is frequently associated with high postoperative pain intensity. Our results demonstrate that intraoperative and drain-based ropivacaine infiltration – alone or combined with prophylactic oxycodone – effectively reduced pain intensity and opioid demand. Among the strategies tested, local anaesthetic infiltration alone offered the most favourable balance of efficacy and tolerability. Given the established link between severe postoperative pain, recovery quality, and the risk of chronic postsurgical pain, we strongly recommend incorporating these approaches, especially local anaesthetic infiltration as part of standard multimodal, preventive perioperative care.

Acknowledgments

The authors thank the patients for their willingness to participate in this study, the pain team at our institution, as well as the operating room nurses and colleagues, Sabrina Winkler, Ines Koch, and Stefanie Schuetze, for support in management of study patients helping implement the new standard in pre-emptive pain management.

Statement of Ethics

This study was conducted ethically in accordance with the World Medical Association Declaration of Helsinki and was approved by the Local Ethics Committee of the Jena University Hospital (Approval No. 2722-12/09). Before entering the study, all patients gave their written informed consent.

Conflict of Interest Statement

Winfried Meissner’s institution received grants from European Commission, Gemeinsamer Bundesausschuß (GBA), Medtronic, and Vertanical. Winfried Meissner received consulting fees from Merck, Sanofi, Tafalgie, Mundipharma, and Grünenthal. Winfried Meissner received payment for lectures from Kyowa. The other authors declare no conflicts of interest.

Funding Sources

The authors received no special funding for this study.

Author Contributions

Study concepts: Ingo B. Runnebaum and Winfried Meissner. Study design: Ingo B. Runnebaum and Jorge Jiménez Cruz. Data acquisition: Felix Roser and Jorge Jiménez Cruz. Quality control of data and algorithms: Angela Kather and Jorge Jiménez Cruz. Data analysis and interpretation: Jorge Jiménez Cruz, Ingo B. Runnebaum, Kristin Nicolaus-Tellenbach, and Norah L.A. Emrich. Statistical analysis: Jorge Jiménez Cruz. Manuscript preparation: Jorge Jiménez Cruz, Ingo B. Runnebaum and Norah L.A. Emrich. Manuscript review: Angela Kather and Ingo B. Runnebaum.

Funding Statement

The authors received no special funding for this study.

Data Availability Statement

Data are available from the authors upon reasonable request.