Abstract
Objective:
To evaluate whether the various surgical treatment reserved for ilioinguinal, iliohypogastric, and genital branch of the genitofemoral nerves, during open hernia mesh repair, is effective in reducing chronic postoperative pain.
Background:
Interest in chronic groin pain following herniorrhaphy has escalated, in recent years, due both to treatment and legal implications. However, much debate still exists concerning which treatment to reserve for the 3 inguinal sensory nerves.
Methods:
A multicentric prospective study involving 11 Italian institutions led to the recruitment of 973 cases of hernioplasty. All surgeons were asked to report whether or not each nerve had been identified and preserved or divided. The main endpoint of the study was the evaluation of moderate to severe chronic pain at 6 months and 1 year.
Results:
Overall, the presence of groin pain at the 6-month and 1-year follow-up was 9.7% and 4.1%, respectively. Pain was mild in 7.9% and moderate to severe in 2.1%, at 6 months, and mild in 3.6% and moderate to severe in 0.5%, at 1 year. Univariate and multivariate analysis showed that lack of identification of nerves is significantly correlated with presence of chronic pain, the risk of developing inguinal pain increasing with the number of nerves not detected. Likewise, division of nerves was clearly correlated with presence of chronic pain.
Conclusions:
The present findings indicate that identification and preservation of nerves during open inguinal hernia repair reduce chronic incapacitating groin pain and that, in the majority of patients with chronic pain at 6 months, the pain at 1 year is resolved only with conservative or medical treatment.
Lack of a uniform description of treatment reserved for ilioinguinal, iliohypogastric, and genital branch of genitofemoral nerves during herniorrhaphy hampers definitive considerations on the risk of developing chronic groin pain. In 973 cases of open mesh hernioplasty, the authors found an increasing risk of developing chronic pain with the number of nerves not identified or divided.
Although chronic pain following inguinal hernia repair is a well-known complication, very few data are available from large consecutive prospective studies. The reported incidence has been increasing in recent years, ranging from ≤3% to 12%.1–3 However, when it does occur, it represents a substantial diagnostic and therapeutic challenge both for the surgeon and patient; moreover, legal problems may occur, especially if the patient has not provided acceptable informed consent.
While there are many reports in the literature concerning presentation, diagnosis, and modes of treatment of chronic pain, very few series have studied the causes. The beneficial effects of preservation of the ilioinguinal nerve in reducing chronic postoperative pain have been described in several studies, but the clinical usefulness has not yet been investigated in large prospective trials; moreover, to our knowledge, no data are available regarding the treatment of all inguinal nerves (ilioinguinal, iliohypogastric, and genital branch of genitofemoral nerves) during primary groin hernioplasty.
This report would appear to be the first in the literature presenting the results of a multicentric prospective clinical trial designed to assess the role of identification versus nonidentification and preservation versus division of the inguinal nerves on chronic postoperative pain following open inguinal polypropylene mesh hernia repair.
This study was intentionally designed not randomized to evaluate whether the different surgical approaches adopted on inguinal nerves, during hernia repair, may have any influence on chronic pain.
METHODS
A total of 11 Italian institutions took part in a prospective multicentric study. Institution approval was obtained by each center.
All patients 18 years of age and older with primary inguinal hernias admitted to surgical units of the centers taking part in the study between January 2002 and June 2003 and candidate for nonemergency open mesh inguinal hernioplastic repair were potentially eligible for the study. These patients were screened to detect any condition requiring exclusion or that might have had a substantial effect on the surgical treatment; briefly, exclusion criteria were as follows: mesh allergy, neurologic disorders (including patients requiring analgesics or suffering from chronic pain), and previous surgery in the inguinal region. Each surgeon taking part in the study was asked to perform an inguinal mesh hernioplastic repair (according to Lichtenstein's4 or Trabucco's technique5); as usual, no recommendations were made regarding identification or preservation of inguinal nerves.
All surgeons were asked to complete a form immediately after the operation, providing the following data: hernia type (direct, indirect, combined, sliding), identification/nonidentification and treatment (preserved, injured, or divided) of each inguinal nerve (ilioinguinal, iliohypogastric, genital branch of genitofemoral nerves). A nerve was considered injured if stretched or burned.
Patients were observed at routine follow-up 1 week and 1 month, postoperatively, in the outpatient unit. Thereafter, patients were asked to return as outpatients or were interviewed by telephone, 3 months, 6 months, and 1 year after surgery. They were requested to provide information concerning pain, use of analgesics, restriction of daily activity, as well as need to consult a physician due to pain in the groin.
Pain was graduated with a 4-point verbal-rank scale: none, mild, moderate, or severe. Mild pain was defined as occasional or discomfort that did not limit daily activity, with a return to prehernia lifestyle without the need of analgesics. Moderate pain was defined as pain that interfered with return to normal everyday activities with analgesics rarely being needed. Severe pain was defined as pain that incapacitated the patient, at frequent intervals, or interfered with everyday activities with frequent need of pain-killers. Patients were asked to express agreement or disagreement on a 4-point verbal-rank scale.
Daily activity included both physical and sports activities such as walking, lifting a bag of fruit, playing tennis, or jogging.
Patient follow-up, whether in the outpatient unit or by means of telephone calls, was always performed with the same 4-point verbal-rank scale. All patients with moderate to severe chronic pain were also submitted to a thorough clinical examination to exclude recurrence. The main endpoint of the study was evaluation of moderate to severe chronic pain at 6 months and 1 year.
The definition of the International Association for the Study of Pain regarding chronic pain (pain persisting beyond the normal tissue healing time, assumed to be 3 months) was used in this study.6
Statistical Analysis
Statistical analyses were performed using the Statistical Package for the Social Sciences (SPSS) for Windows, version 9.01 (SPSS, Chicago, IL). P < 0.05 was considered significant. χ2 tests were used to assess associations between different variables and the presence of chronic pain; t tests were used to compare the means of certain characteristics between patients with and without chronic pain.
RESULTS
During the 18-month patient accrual, 955 patients were enrolled in the study and operated on for nonrecurrent inguinal hernia, with 1050 total repairs being performed (95 patients presented bilateral hernias).
The study population comprised 955 patients (927 male, 28 female; mean age, 55 years; range, 18–92 years). At physical examination, 977 hernias were confined to the inguinal region, while 73 (6.9%) were located in an inguinal-scrotal site. Hernias were right and left in 578 and 472 patients, respectively. A total of 297 patients (31%) were operated on in the day hospital setting and were discharged after a mean time of 2 hours, whereas 658 (69%) were treated as inpatients.
Excluded from the study were 60 patients with hernioplasty (17 with bilateral hernias) due to lack of postoperative data (incomplete charts n. 62) and lost to follow-up (n = 15). Overall, the study population and statistical analysis comprised 895 patients with 973 hernioplasties.
The postoperative surgical-site complication rate was 8.4%: inguinal hematoma in 58 cases, scrotal hematoma in 14, and wound infection in 8.
Early postoperative pain (at 1 month) was mild in 185 (19%) cases and moderate to severe in 65 (6.7%). As far as concerns the main outcome of the study, the overall presence of groin pain at the 6-month and 1-year follow-up was 9.7% and 4.1%, respectively. Pain was mild in 7.9% (n = 74) and moderate to severe in 2.1% (n = 21) at 6 months and mild in 3.6% (n = 35) and moderate to severe in 0.5% (n = 5) at 1 year (Fig. 1).
FIGURE 1. Incidence of chronic groin pain at 1-, 6-, and 1-year follow-up.
Identification rate and type of treatment (preserved, injured or divided) for each inguinal nerve during surgery are outlined in Table 1. Overall, all 3 nerves have been concomitantly identified in 380 hernioplasties (39%); not identified in 189 hernioplasties (19.4%). In the remaining 404 hernioplasties (41.6%), 1 (n = 260) or 2 nerves (n = 144) have not been identified (Table 2).
TABLE 1. Nerve Identification Rate and Type of Treatment for Each Individual Nerve
TABLE 2. Repair Subgroups Classified According to Treatment of 3 Inguinal Nerves During Surgery, and Incidence of Chronic Pain at 6 Months
Of the 380 hernioplasties with all nerves identified, 310 (81.6%) had all nerves preserved, 10 (2.6%) had all nerves dissected, and the remaining 60 (15.8%) had at least 1 or 2 nerves injured or divided. The overall incidence of pain in this group was 5.5% at 6 months: mild in 16 cases (4.2%) and moderate to severe in 5 cases (1.3%). Briefly, moderate to severe pain occurred in 4 (40%) of 10 hernioplasties with all nerves divided and in 1 (1.7%) of 60 hernioplasties with 1 or 2 nerves injured or divided. In none of the cases of hernia repair with all nerves preserved was chronic moderate to severe pain reported.
As far as concerns the group of 404 hernioplasties with identification of only 1 or 2 nerves, the incidence of pain was 8.1%, with mild and moderate to severe pain being found in 26 (6.4%) and 7 (1.7%) hernioplasties, respectively. Indeed, moderate to severe pain occurred in 4 of 144 (2.8%) and in 3 of 260 (1.1%) hernioplasties in which 2 or 1 nerve had not been identified, respectively.
Of the 189 hernioplasties in which the all 3 nerves were not identified, the overall incidence of pain at 6 months was 21.6%: 32 (17%) and 9 (4.7%) experienced mild and moderate to severe pain, respectively.
Statistical analyses demonstrate that patients in whom all nerves were identified had significantly less risk of developing moderate to severe chronic pain than those patients with only 1 or 2 nerves identified or patients in whom nerves were not identified during surgery (P = 0.02; Table 2).
Treatment of the 3 nerves in the 21 cases of hernioplasty associated with moderate to severe chronic pain at 6 months is outlined in Table 3. These data demonstrate that in 43% of cases (n = 9), the 3 nerves were not recognized during surgery; in 33.3% of cases (n = 7), 1 or 2 nerves were not identified; in 19% (n = 4) all 3 nerves were resected; and only in 4.7% of cases was 1 nerve injured.
TABLE 3. Characteristics of 21 Cases of Hernioplasty With Moderate to Severe Pain
Of the 21 patients with chronic pain, 15 already had mild or moderate to severe pain at the 1-month follow-up while the remaining 6 cases developed invalidating pain only later, no pain having been reported at the first follow-up observation. Of the last 6 patients, 5 still have moderate to severe pain at 1 year, while the remaining 16 patients slowly recovered with medical treatment. None of the 21 patients was obese. Overall, in 76% of patients with moderate to severe pain, pain was completely eliminated within 1 year.
No correlation was found between moderate to severe pain at 6 months and type of hernia, type of anesthesia, repair technique used, or surgeon experience (Table 4).
TABLE 4. Moderate to Severe Pain at 6 Months According to Intraoperative and Technical Factors in 973 Hernioplasties
Univariate analysis showed that lack of identification of nerves is significantly correlated with the presence of chronic pain, the risk of developing inguinal pain increasing with the number of nerves concomitantly not detected. Likewise, the division of nerves was strongly correlated with the presence of chronic pain. Traumatism of nerves, on the contrary, was not statistically correlated with pain due to the restricted number of patients. Age and gender did not show a significant correlation with chronic pain at univariate analysis (Table 5).
TABLE 5. Univariate Analysis: Risk of Complaining of Pain at 6 Months According to Nerve Treatment
The prognostic significance of nonidentification of nerves during surgery was confirmed at multivariate analysis; the relative risk of developing moderate to severe inguinal pain increases from 2.2 to 19.2 if 1 or 3 nerves have not been recognized, respectively (Table 6).
TABLE 6. Multivariate Analysis: Risk of Complaining of Pain at 6 Months According to Nerve Treatment
Because of the small number of patients with all nerves identified presenting with chronic pain, it was not possible to statistically correlate chronic pain and division of any single nerve.
DISCUSSION
Chronic pain following inguinal hernia repair is becoming a significant clinical problem, involving an increasing number of patients and surgeons, as shown by the rising number of publications over the last 10 years dealing with postoperative pain syndrome. Several explanations may be offered, namely, the low recurrence rates associated with the use of mesh repair that have shifted the hernia surgeons’ attention from recurrence to other outcome parameters and the fact that patients today are more aware of pain syndromes. However, more and more often, patients come to our attention complaining of groin pain, after a hernia operation performed elsewhere, both for a second opinion regarding treatment and for possible legal procedures.
First of all, it is important to differentiate chronic pain from acute pain. Early postoperative pain is usually seen soon after surgery; it is easily and successfully managed with analgesics and generally resolves within 15 to 30 days of surgery without the need of further treatment. On the contrary, moderate to severe chronic pain, generally seen 3 months after surgery, may result in a potentially debilitating condition, becoming not only a therapeutic challenge but sometimes resulting in the patient being unable to perform daily activities or to return to work. It may be refractory to analgesics and successfully treated only by further surgery, such as neurectomy, neurolysis, or excision of the neuroma.7–12 This complication is more frequent than would appear from reports in the literature, with the incidence increasing in recent years.
Albeit the exact incidence of chronic pain remains to be elucidated, varying in different series and only a few studies presenting long-term follow-up and a sufficiently large study population. While studies from dedicated centers have reported a 0% to 2% incidence of chronic pain,13–15 others, from public hospitals and universities, reported that 12% to 37% of patients still presented pain 1 year after hernia repair.16 The report from the Danish Hernia Data Base Group suggests that the incidence of chronic pain, regardless of grade, 12 months after surgery, is approximately 29%, with 11% of patients complaining of severe, invaliding pain.17 The variability of this range may also depend on the different modality of graduating and defining pain. According to some authors, in the present study, chronic pain can be defined as “pain persisting beyond the normal tissue healing time, assumed to be 3 months.”6 Furthermore, assessment of chronic pain was often not the primary aim of many studies.
Several factors have been proposed as predictors of chronic pain, such as experience of the surgeons and surgery due to recurrence,18 damage to inguinal nerves,19 and mesh implantation.20 However, the pathogenic aspects of chronic pain are still unknown and only hypothesized. The different surgical techniques used as well as the difference in management of the inguinal nerves during surgery have been held to be responsible for neuralgia. Some authors think that the widespread use of implanted prosthetic mesh, as well as open, instead of laparoscopic, inguinal hernia repair may play a role in the increased incidence of chronic pain.21,22 However, tension-free mesh repairs are reported to be less likely to cause chronic groin pain than non-mesh repairs;23,24 albeit, no statistically significant difference appears to exist between open mesh, versus laparoscopic mesh repair,25 even if evidence would appear to be contradictory.21,26–31
Partial division, neuroma formation, injury or entrapment of the ilioinguinal, iliohypogastric, or genitofemoral nerves are other possible causes reported to be responsible for chronic pain after herniorrhaphy.
Much controversy exists regarding which treatment to reserve for the inguinal nerves during hernia repair. Elective division of the ilioinguinal nerve has been proposed by some authors to reduce the risk of postoperative chronic pain.32,33 Lichtenstein et al recommend to always preserve the nerve to minimize the incidence of chronic pain.2 Some studies recommend that nerve ends be ligated34 or intentionally divided35 to reduce the risk of chronic pain, but no documentation has been forthcoming regarding the outcome of these recommendations. Others have suggested that the nerves be divided or ligated only when their course, on the operating field, would lead to the risk of injury or if they interfere with positioning of the mesh.32 Other studies have failed to show any relationship between the division or preservation of the ilioinguinal nerve and the risk of developing chronic pain,16,36,37 if division of the nerve is performed as close as possible to the site where it leaves the retroperitoneum. However, current literature is inconsistent concerning this point and opinions differ considerably. Moreover, to our knowledge, the clinical effect of identification versus nonidentification and preservation versus division of all 3 inguinal nerves, on chronic postoperative groin pain, has not been investigated in large prospective trials.
The present large-scale prospective multicentric study, with a 98% of follow-up rate, clearly shows that the risk of developing chronic postoperative groin pain is directly related to the number of nerves identified. Nerve injury during surgery appears to be an important factor influencing chronic pain. Indeed, chronic pain at 6 months after surgery was zero in those patients in whom all 3 nerves were identified and preserved, compared with the 40% incidence when these nerves were all divided, or 4.7% when not all nerves were identified. These data would appear to suggest that, if 1 or more nerves are not detected during surgery, it is possible that they could be inadvertently sectioned, entrapped, or secured, for example, if a continuous suture is introduced along the inguinal ligament or injured if the external spermatic vessels are divided to skeletonize the cord and thus generate severe pain even some considerable time after the operation. The increased risk of developing chronic pain with the number of nerves divided can be explained by the fact that resection of the nerve has generally been performed distal to its origin, leaving the site of the injured nerve intact to continue to generate the pain signal and exposed to neuroma formation. Results from studies in which operative management of an injured nerve is reported to be responsible for severe chronic pain suggest that, if the nerve identified is inadvertently divided, it is important to resect it, as proximally as possible, so that it would not interfere or come into contact with the mesh, thus allowing retraction of the proximal segment into the ventral muscle or retroperitoneum.8,33,38
It should not be forgotten that nerves are most often injured when the surgeon is unaware of the location and course or fails to recognize these during surgery. Caution is stressed when teaching this common procedure to resident physicians. However, it is important to underline that most of our patients with chronic pain slowly recovered at 1 year only with conservative or medical treatment. This suggests that no surgical treatment should be considered for at least 1 year for these patients.
CONCLUSION
Bearing in mind the results emerging from the present prospective multicentric study, and in agreement with other authors,14 we wish to stress the importance of always identifying and preserving all 3 nerves of the inguinal canal, during hernioplastic surgery, to minimize the incidence of chronic postoperative groin pain.
Footnotes
Reprints: Sergio Alfieri, MD, Department of Digestive Surgery, Catholic University of Sacred Heart, Largo Agostino Gemelli 8, 00168, Rome, Italy. E-mail: s.alfieri@rm.unicatt.it.
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