POSTOPERATIVE PAIN AND RECOVERY PROFILES FOLLOWING LAPAROSCOPIC VS. CONVENTIONAL HERNIA REPAIR: A RANDOMIZED CONTROLLED TRIAL

Abstract

Background: Hernias of the groin occur very frequently in adults, being diagnosed in approximately 15–20% of the population world-wide, and undergoing surgical repair an estimated 20 million times per year[1]. Similarly, the number of cases in India is very large (approximately 1.5–2.0 million)[2]. Standard open Lichtenstein mesh repair is effective and durable[3]; however, most adults experience moderate to severe pain during the initial period following surgery, and will have prolonged hospitalizations, and delayed return to daily routines. Minimal invasive laparoscopic repair (TEP/TAPP) of the inguinal hernia does not require a groin incision and has been shown to decrease the amount of postoperative pain, and hasten return to daily routines[4][5]; however, it takes longer to perform than open repair. Materials and Methods: A prospective, single center RCT of 100 adults (ASA I–III, age 18–75) with unilateral primary inguinal hernia was completed. Patients were randomly assigned (sealed envelope randomization) to undergo laparoscopic repair (laparoscopic n = 50) or open Lichtenstein repair (open n = 50) that was performed by experienced surgeons. Adults with bilateral or recurrent hernias, obstruction, or contraindications to general anesthesia were excluded from participation in this study. All participants received the same perioperative care (general anesthesia, antibiotic prophylaxis, and a standardized regimen of acetaminophen and nonsteroidal anti-inflammatory drugs [NSAID] with opioids used as needed for pain relief). Participants' postoperative pain was measured with a 0–10 visual analogue scale (VAS) at rest on postoperative day 1 (24 hours), day 3 (72 hours), and day 7. Additional secondary outcomes were total analgesic use (number of tablets used within the first 48 hours), length of hospitalization, time to return to usual activities, and complications (hematoma, seroma, infection, chronic pain). A sample size of 50 per treatment arm was determined to be necessary to detect a 25% difference in pain level on postoperative day 1 (α = 0.05) with 80% power. SPSS version 26 was used to analyze data collected via t-tests and/or chi-squared analyses. Results: Patients' baseline demographic characteristics (e.g., age ~49 years, >90% males, BMI and ASA distribution) were equivalent (see Table 1). The operative time for laparoscopic repair was significantly longer (mean 95 ± 20 minutes vs. 60 ± 15 minutes; p < 0.001). The mean pain levels are shown in Fig. 1 (below): the patients in the laparoscopic repair group reported significantly less pain at every evaluation time point. For example, the mean VAS on postoperative day 1 was 4.0 ± 1.5 for laparoscopic repair vs. 6.3 ± 1.5 for open repair (p < 0.001); on postoperative day 3 it was 2.6 ± 1.0 vs. 4.2 ± 1.0 (p < 0.001); and on postoperative day 7 it was 0.4 ± 0.5 vs. 1.6 ± 0.5 (p < 0.001). Consequently, the patients in the laparoscopic repair group took fewer analgesics (mean 2.8 ± 1.5 vs. 4.8 ± 2.0; p < 0.001) within the first 48 hours following surgery. Additionally, the laparoscopic repair group returned to their normal activities faster (mean hospital stay 1.9 ± 0.5 days vs. 3.1 ± 0.5 days; p < 0.001, and mean time to resume normal activity 8.1 ± 2.6 vs. 12.0 ± 2.8 days; p < 0.001). Complications occurred infrequently, and were equivalent (seroma 10% vs. 6%, hematoma 4% vs. 0%, infection 6% vs. 2%; all p > 0.1). No recurrences were identified at 1 month follow-up.Conclusion: Laparoscopic inguinal hernia repair results in significantly reduced postoperative pain and analgesic requirements, and allows for a faster return to normal activities when compared to traditional open repair of the inguinal hernia. While laparoscopic repair of the inguinal hernia requires additional time to perform, the improvement in postoperative comfort and recovery time suggests that there are advantages for patients who undergo laparoscopic repair for suitable patients[5][6]. These findings support the increased adoption of minimal invasive techniques for inguinal hernia repair to achieve better patient centered outcomes.