Abstract
Background:
Breast surgeries are commonly performed under general anesthesia. The aim of the study was to compare postoperative pain following modified radical mastectomy under thoracic epidural anesthesia versus general anesthesia with the use of laryngeal mask airway.
Materials and Methods:
This randomized controlled study was performed on hundred patients undergoing unilateral modified radical mastectomy. The patients were assigned into two equal groups, E and G. Group E patients received thoracic epidural anaesthesia, and group G received general anesthesia. The primary objective was to compare postoperative pain scores between the two groups. Secondary objectives included incidence of postoperative sore throat, hoarseness of voice, cough, nausea and vomiting, perioperative analgesic requirement, patient and surgeon satisfaction, duration of hospital and intensive care unit (ICU) stay, and any associated anesthesia complications.
Results:
Both groups were similar with respect to demographics. Postoperative pain score was significantly lower in Group E at all time points. The perioperative analgesic requirement was significantly higher in Group G than in Group E, and this was statistically significant with P < 0.001. Duration of hospital stay and intraoperative hemodynamics were comparable between the two groups. Patient satisfaction was significantly higher in Group G; however, surgeons were satisfied with both methods. Sore throat, cough, hoarseness of voice, nausea and vomiting, and duration of ICU stay were significantly higher in group G. Infiltration of local anesthetic in the axilla was required in 10% of the patients in the epidural group.
Conclusions:
Although patients found general anesthesia more satisfying, thoracic epidural anesthesia provided significantly better postoperative analgesia compared with general anesthesia with laryngeal mask airway inpatients undergoing modified radical mastectomy and was associated with significantly lower ICU stay, comparable surgeon satisfaction with lower incidence of postoperative sore throat, nausea and vomiting, hoarseness of voice, and cough.
Keywords: Breast cancer, epidural anaesthesia, general anesthesia, thoracic
Résumé
Contexte:
Les chirurgies du sein sont couramment réalisées sous anesthésie générale. Le but de cette étude était de comparer la douleur postopératoire après une mastectomie radicale modifiée sous anesthésie péridurale thoracique par rapport à l’anesthésie générale avec utilisation d’un masque laryngé.
Matériel et Méthodes:
Cette étude randomisée et contrôlée a été réalisée sur cent patientes subissant une mastectomie radicale modifiée unilatérale. Les patientes ont été réparties en deux groupes égaux, E et G. Les patientes du groupe E ont reçu une anesthésie péridurale thoracique, et celles du groupe G une anesthésie générale. L’objectif principal était de comparer les scores de douleur postopératoire entre les deux groupes. Les objectifs secondaires comprenaient l’incidence des maux de gorge postopératoires, de l’enrouement de la voix, de la toux, des nausées et vomissements, des besoins en analgésiques peropératoires, de la satisfaction de la patiente et du chirurgien, de la durée du séjour à l’hôpital et en unité de soins intensifs (USI), ainsi que de toute complication anesthésique associée.
Résultats:
Les deux groupes étaient similaires en ce qui concerne les données démographiques.1 Le score de douleur postopératoire était significativement plus faible dans le Groupe E à tous les moments. Le besoin en analgésiques peropératoires était significativement plus élevé dans le Groupe G que dans le Groupe E, et cela était statistiquement significatif avec $P < 0.001$. La durée du séjour à l’hôpital et l’hémodynamique peropératoire étaient comparables entre les deux groupes. La satisfaction des patientes était significativement plus élevée dans le Groupe G ; cependant, les chirurgiens étaient satisfaits des deux méthodes. Les maux de gorge, la toux, l’enrouement de la voix, les nausées et vomissements, et la durée du séjour en USI étaient significativement plus élevés dans le Groupe G. Une infiltration d’anesthésique local dans l’aisselle a été nécessaire chez 10 % des patientes du groupe péridural.
Conclusions:
Bien que les patientes aient trouvé l’anesthésie générale plus satisfaisante, l’anesthésie péridurale thoracique a procuré une analgésie postopératoire significativement meilleure par rapport à l’anesthésie générale avec masque laryngé chez les patientes subissant une mastectomie radicale modifiée, et était associée à une durée de séjour en USI significativement plus courte, à une satisfaction du chirurgien comparable avec une incidence plus faible des maux de gorge postopératoires, des nausées et vomissements, de l’enrouement de la voix et de la toux.
Mots-clés: Cancer du sein, anesthésie péridurale, anesthésie générale, thoracique
INTRODUCTION
Breast cancer is the most common cause of cancer in women. Breast surgeries are commonly performed under general anesthesia. Surgery, pain, opioid use, stress hormones, and immune suppression are suspected to have an influence on cancer recurrence.[1] Cervical or thoracic epidural, thoracic paravertebral block, pectoral nerve block, erector spinae block, and segmental thoracic spinal anesthesia are tried in breast cancer surgeries to avoid general anaesthesia.[,3,4] Animal studies have shown that opioids, volatile anesthetics, thiopental, and ketamine could inhibit natural killer cell activity and cause cancer metastasis.[5,6] Regional plane blocks are used along with general anesthesia to reduce the consumption of opioids. Limitations of the use of regional blocks are technical difficulties in performing the blocks and increased possibilities of complications like pneumothorax. We hypothesized that the use of thoracic epidural anesthesia would provide adequate anesthesia for performing modified radical mastectomy, thereby reducing complications, pain, intensive care unit (ICU), hospital stay and healthcare costs. The primary objective of this study was to compare postoperative pain scores between the two groups. Secondary objectives included intraoperative and postoperative analgesic requirement, duration of hospital and ICU stay, anesthetic cost, patient and surgeon satisfaction, incidence of postoperative sore throat, nausea and vomiting, hoarseness of voice, and cough.
MATERIALS AND METHODS
This prospective, randomized study was conducted after obtaining approval from the hospital ethical committee (IEC-AIMS-2020-ANES-012), the clinical trial registry of India (CTRI/2020/06/025816), and informed written consent from patients from December 2020 to December 2023. One hundred female patients aged 18–60 years, of the American Society of Anaesthesiologists (ASA) physical status 2–3, undergoing unilateral modified radical mastectomy were included in this study [Figure 1]. Patients with any contraindications to epidural, infection at the site of the planned epidural placement, any coagulation disorders, or known allergy to lignocaine or any anesthetic drug were excluded from the study.
Figure 1.
Consort flow diagram
The patients were randomly assigned into two equal groups, G and E, based on a computer-generated random sequence of numbers. Concealment was achieved by the closed envelope technique. Patients in both groups received oral ranitidine 150 mg, metoclopramide10 mg, and alprazolam 0.25 mg on the night before surgery and ranitidine 150 mg and metoclopramide 10 mg on the morning of surgery. In the operation theater, an intravenous (IV) cannula was inserted and monitoring with electrocardiography, a noninvasive blood pressure monitor, and a pulse oximeter were done. Standard general anesthesia protocol was followed in Group G. Patients were preoxygenated with 100% O2; glycopyrrolate 0.2 mg, midazolam 2 mg, and fentanyl 2 µg/kg were given intravenously. They were then induced with IV propofol 1.5–2.5 mg/kg till there was the loss of response to verbal command. Classic LMA size 3/4 was inserted after full deflation. Patients were maintained on O2, N2O and isoflurane 0.5%–1.5%. LMA cuffs were filled with 20/30 mL of room air.
Patients in Group E were placed in the left lateral position and under strict aseptic precautions; an epidural catheter was placed in T5–T6 using an 18-gauge Tuohy needle. Supplemental oxygen 5 L/min was administered through a face mask for the entire duration of the surgery. The epidural catheter was inserted 3–5 cm into the epidural space. A test dose of 3 mL of 2% lignocaine with epinephrine 1:200,000 was given to exclude intravascular or intrathecal injection. A titrated dose of 5–8 mL of 2% lignocaine with 1:200,000 adrenaline was injected through the catheter, and anesthetic dermatomal levels achieved were determined by pinprick. Following this, a titrated infusion of the same drug was maintained.
Toward the end of the surgery, IV ondansetron 4 mg and IV paracetamol 1 g were given to patients in both groups, and the surgeon gave local infiltration with 5–10 mL of 2% lignocaine with 1:200,000 adrenaline. In Group G, on completion of the surgery, LMA was removed after suctioning and deflating the cuff. All patients were shifted to the postoperative ICU after surgery. In Group E, the epidural catheter was removed before shifting to ICU. In the ward, all patients received oral paracetamol 650 mg 8th hourly. Patients were given rescue analgesia with IV tramadol 50 mg if the pain score was ≥4. The total dose of tramadol given in the first 24 h was noted for both groups.
Postoperative pain scores, sore throat, cough, hoarseness, nausea and vomiting were monitored by the anesthetist who was blinded to the group allocation, and the responses were noted at 0, 4, and 24 h. Total intraoperative fentanyl and postoperative tramadol consumption, anesthesia costs, and the duration of ICU and hospital stays were documented. Pain intensity was assessed using a numerical pain scale of 0–10 (0 = No pain to 10 = Worst imaginable pain). Ward and home readiness were assessed by the operating surgeon. Patient and surgeon satisfaction with the anesthetic experience was noted. They were asked to rate their overall experience with the anesthetic technique as “satisfactory” or “unsatisfactory.”
As there were no previous studies comparing epidural with general anesthesia using laryngeal mask airway, a pilot study was conducted and based on the mean and standard deviation of pain score between groups E (1.2 ± 0.788) and G (2.3 ± 1.159), with 95% confidence and 80% power, the minimum sample size came to 13 in each group. However, we recruited 50 patients in each group as an adequate sample size can reduce Type II error, which can result in skewed results.
To test the statistically significant difference in the mean percentage difference of pain score, duration of hospital, ICU stay, and anesthetic cost between two groups, independent sample t-test was applied. To test the statistical significant association of incidence of postoperative hoarseness of voice, cough, postoperative nausea, and vomiting with group, Pearson’s Chi-square test was applied. P < 0.05 was considered statistically significant. Statistical analysis was done using IBM SPSS 20.0 (SPSS Inc., Chicago, IL, USA).
RESULTS
Both groups were similar with respect to demographics and ASA physical status [Table 1]. Postoperative pain score was significantly less in Group E at all time points with P ≤ 0.002 [Table 2]. Intraoperative fentanyl consumption was zero in group E, whereas it was 150 µg in 84%, 160 µg in 6%, 180 µg in 6%, and 200 µg in 4% of patients in Group G. This was statistically significant with a P < 0.001. None of the patients in group E required postoperative tramadol, whereas 54% patients used 50 mg tramadol in group G. This was also statistically significant with a P < 0.001. Surgeons were satisfied with anaesthesia in 92% in group E and 100% in Group G. This was not statistically significant with a P = 0.117. On comparing patient satisfaction, it was found that 80% of patients in the epidural group and 96% of patients in Group G found anesthesia satisfactory. This was also not statistically significant with P = 0.042 [Table 3].
Table 1.
Demographic data
| Variables | Group E (mean±SD) | Group G (mean±SD) | P |
|---|---|---|---|
| Age (year) | 56.24±12.07 | 52.86±11.92 | 0.162 |
| Weight (kg) | 69±10.35 | 66.64±10.15 | 0.252 |
| Height (cm) | 153.54±7.32 | 154.40±5.69 | 0.514 |
| ASA score 2, n (%) | 41 (82) | 41 (82) | 1 |
| ASA score 3, n (%) | 9 (18) | 9 (18) |
SD=Standard deviation, ASA=American Society of Anaesthesiologists
Table 2.
Comparison of pain score
| Time (h) | Pain score | Group E, n (%) | Group G, n (%) | P |
|---|---|---|---|---|
| 0 | 0 | 18 (36) | 3 (6) | <0.001 |
| 1 | 12 (24) | 7 (14) | ||
| 2 | 20 (40) | 15 (30) | ||
| 3 | 0 | 13 (26) | ||
| 4 | 0 | 11 (22) | ||
| 5 | 0 | 1 (2) | ||
| 4 | 0 | 15 (30) | 4 (8) | <0.001 |
| 1 | 17 (34) | 6 (12) | ||
| 2 | 18 (36) | 15 (30) | ||
| 3 | 0 | 15 (30) | ||
| 4 | 0 | 6 (12) | ||
| 5 | 0 | 4 (8) | ||
| 24 | 0 | 16 (32) | 7 (14) | 0.002 |
| 1 | 19 (38) | 17 (34) | ||
| 2 | 15 (30) | 15 (30) | ||
| 3 | 0 | 5 (10) | ||
| 4 | 0 | 6 (12) |
Table 3.
Opioid consumption and satisfaction scores
| Variables | Score | Group E, n (%) | Group G, n (%) | P |
|---|---|---|---|---|
| Intraoperative fentanyl (µg) | 0 | 50 (100) | 0 | <0.001 |
| 150 | 0 | 42 (84) | ||
| 160 | 0 | 3 (6) | ||
| 180 | 0 | 2 (4) | ||
| 200 | 0 | 3 (6) | ||
| Postoperative tramadol (mg) | 0 | 50 (100) | 23 (46) | <0.001 |
| 50 | 0 | 27 (54) | ||
| Surgeon satisfaction | 46 (92) | 50 (100) | 0.117 | |
| Patient satisfaction | 40 (80) | 48 (96) | 0.042 |
Anesthesia time was comparable between the two groups 124.48 ± 11.34 versus 123.22 ± 9.14 min, with P = 0.542. The duration of ICU stay was significantly less in Group E (2.48 ± 0.50 vs. 4.40 ± 0.57 days, P < 0.001). However, the total duration of hospital stay was comparable between the two groups (1.48 ± 0.50 vs. 1.50 ± 0.51 days, P = 0.853). The total anesthesia cost was also comparable between the two groups (9984 ± 411.25 vs. 9604 ± 1356.07 Rs, with a P = 0.063) [Table 4].
Table 4.
Duration of anaesthesia, intensive care unit, hospital stay and cost
| Variables | Group E (mean±SD) | Group G (mean±SD) | P |
|---|---|---|---|
| Anaesthesia time (min) | 124.48±11.34 | 123.22±9.14 | 0.542 |
| ICU stay (h) | 2.48±0.50 | 4.40±0.57 | <0.001 |
| Hospital stay (days) | 1.48±0.50 | 1.50±0.51 | 0.843 |
| Cost (Rs) | 9984±411.25 | 9604±1356.07 | 0.063 |
ICU=Intensive care unit, SD=Standard deviation
On comparing sore throat, Group G had a higher incidence of sore throat, which was statistically significant up to 4 h (P = 0.001, <0.001, 0.242 at 0, 4, and 24 h, respectively). Hoarseness of voice, cough, nausea, and vomiting were absent in Group E but the difference between groups was not found to be significant at any time points. Incidences of intraoperative bradycardia, tachycardia, hypotension, and hypertension were also comparable between the two groups [Table 5].
Table 5.
Comparison of complications associated with the procedure
| Variables | Time (h) | Group E, n (%) | Group G, n (%) | P |
|---|---|---|---|---|
| Sore throat | 0 | 0 | 8 (16) | 0.001 |
| 4 | 0 | 3 (6) | <0.001 | |
| 24 | 0 | 2 (4) | 0.242 | |
| Cough | 0 | 0 | 8 (16) | 0.006 |
| 4 | 0 | 3 (6) | 0.242 | |
| 24 | 0 | 2 (4) | 0.495 | |
| Hoarseness of voice | 0 | 0 | 2 (4) | 0.495 |
| 4 | 0 | 2 (4) | 0.495 | |
| 24 | 0 | 0 | 1 | |
| Nausea and vomiting | 0 | 10 (20) | 10 (20) | 1 |
| 4 | 6 (12) | 7 (14) | 1 | |
| 24 | 0 | 2 (4) | 0.495 | |
| Bradycardia | 2 (4) | 0 | 0.495 | |
| Tachycardia | 1 (2) | 6 (12) | 0.112 | |
| Hypotension | 10 (20) | 3 (6) | 0.071 | |
| Hypertension | 1 (2) | 7 (14) | 0.059 |
DISCUSSION
It is well known that cervical epidural anesthesia is more useful for breast surgeries than general anesthesia with endotracheal intubation. Our study, however, is the first to evaluate the effectiveness of general anesthesia with thoracic epidural anaesthesia while preserving spontaneous ventilation with the use of a laryngeal mask airway. Our study had demonstrated that thoracic epidural anesthesia was reliable and provided adequate operating conditions with a better postoperative pain profile over general anesthesia with laryngeal mask airway for modified radical mastectomies.
The epidural group in this study had a considerably lower postoperative pain score. Using epidural anesthesia, sore throats and other problems related to general anesthesia were avoided. In Addition, it assisted in lowering or doing away with the use of perioperative opioids and the negative effects that go along with them. The two anesthetic modalities did not significantly differ in terms of surgeon satisfaction ratings. However, the patients found general anesthesia more satisfactory. Maintaining a quite environment or providing a provision to listen to soothing music while being awake in the operation theater under epidural anesthesia might have improved the patient satisfaction scores. Although we observed a shorter ICU stay with epidural anaesthesia in our trial, there was no change in the length of overall hospital stays or expenses associated with the use of epidural anesthetic. Patients undergoing general anaesthesia experienced hoarseness of voice, coughing, and sore throats. Hemodynamics and nausea and vomiting were similar in the two groups. Clinically, the epidural group experienced a higher incidence of hypotension, which was easily treated with IV ephedrine and fluid boluses. In addition, none of the patients in the epidural group needed vasopressor infusion. Thoracic epidural anaesthesia was used without causing any respiratory depression.
Epidural anesthesia is used in high-risk patients to reduce the side effects associated with general anesthesia. Vishwanath and Safneedha and Vineetha et al. showed that it was feasible to perform modified radical mastectomy under thoracic epidural anesthesia.[7,8] Similar to their study, we used 2% lignocaine with 1 in 200,000 adrenaline for epidural block. In a study by Bhardwaj et al., a high thoracic epidural was used to avoid endotracheal intubation and reduce respiratory complications in a modified radical mastectomy.[9] Oktavia compared thoracic epidural anesthesia and general anesthesia for patients undergoing modified radical mastectomy with axillary lymph node dissection and concluded that continuous thoracic epidural technique did not cause hypertension and tachycardia and was associated shorter hospital stay and could be used as an alternative technique to general endotracheal anesthesia in patients who underwent modified radical mastectomy with axillary dissection.[10] Groeben studied the effect of local anesthetic and high thoracic epidural on bronchial hyper reactivity and concluded that thoracic epidural is safer than general anaesthesia in respiratory compromised patients.[11]
As breast surgeries did not require motor blockade or muscle relaxation, we used a laryngeal mask airway and maintained the patients on spontaneous ventilation. Barreira et al. reported that the use of the laryngeal technique to access airway during general anaesthesia for elective breast surgery was as safe, effective as tracheal intubation and was associated with a lesser hemodynamic response and sore throat.[12] The safety of use of muscle relaxants to patients after chemotherapy and radiotherapy is controversial. Oral mucositis is common following chemotherapy. Administration of succinylcholine to these patients could lead to hyperkalemia as in thermal injury. Radiation-associated thermal injury to muscle cells can also lead to hyperkalemia with the use of succinylcholine.[,14,15]
Aswini et al. compared the use of local anesthetic, ropivacaine and bupivacaine in thoracic epidural anesthesia for modified radical mastectomy and found that ropivacaine was faster in producing an adequate block compared to bupivacaine. We did not assess the time of onset of adequate block in our study. However, in our study, we used lignocaine which has rapid onset of action compared to ropivacaine or bupivacaine.[16]
CONCLUSIONS
Though patients found general anaesthesia more satisfying, thoracic epidural anaesthesia provided significantly better postoperative analgesia compared with general anaesthesia with laryngeal mask airway inpatients undergoing modified radical mastectomy and was associated with significantly lower ICU stay, comparable surgeon satisfaction with lower incidence of postoperative sore throat, nausea and vomiting, hoarseness of voice, and cough.
Conflicts of interest
There are no conflicts of interest.
Acknowledgement
We would like to thank Department of Surgical Oncology.
Funding Statement
Nil.
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