Prospective randomized trial of iliohypogastric-ilioinguinal nerve block on post-operative morphine use after inpatient surgery of the female reproductive tract

<p>Abstract</p> <p>Objective</p> <p>To determine the impact of pre-operative and intra-operative ilioinguinal and iliohypogastric nerve block on post-operative analgesic utilization and length of stay (LOS).</p> <p>Methods</p> <p>We conducted a prospective randomized double-blind placebo controlled trial to assess effectiveness of ilioinguinal-iliohypogastric nerve block (IINB) on post-operative morphine consumption in female study patients (<it>n </it>= 60). Patients undergoing laparotomy via Pfannenstiel incision received injection of either 0.5% bupivacaine + 5 mcg/ml epinephrine for IINB (Group I, <it>n </it>= 28) or saline of equivalent volume given to the same site (Group II, <it>n </it>= 32). All injections were placed before the skin incision and after closure of rectus fascia via direct infiltration. Measured outcomes were post-operative morphine consumption (and associated side-effects), visual analogue pain scores, and hospital length of stay (LOS).</p> <p>Results</p> <p>No difference in morphine use was observed between the two groups (47.3 mg in Group I vs. 45.9 mg in Group II; <it>p </it>= 0.85). There was a trend toward lower pain scores after surgery in Group I, but this was not statistically significant. The mean time to initiate oral narcotics was also similar, 23.3 h in Group I and 22.8 h in Group II (<it>p </it>= 0.7). LOS was somewhat shorter in Group I compared to Group II, but this difference was not statistically significant (<it>p </it>= 0.8). Side-effects occurred with similar frequency in both study groups.</p> <p>Conclusion</p> <p>In this population of patients undergoing inpatient surgery of the female reproductive tract, utilization of post-operative narcotics was not significantly influenced by IINB. Pain scores and LOS were also apparently unaffected by IINB, indicating a need for additional properly controlled prospective studies to identify alternative methods to optimize post-surgical pain management and reduce LOS.</p

Investigating the effect of intra-operative infiltration with local anaesthesia on the development of chronic postoperative pain after inguinal hernia repair. A randomized placebo controlled triple blinded and group sequential study design [NCT00484731]

<p>Abstract</p> <p>Background</p> <p>Inguinal hernia repair is one of the most frequently performed procedures in Switzerland (15'000/year). The most common complication postoperatively is development of chronic pain in up to 30% of all patients irrespective of the operative technique.</p> <p>Methods/Design</p> <p>264 patients scheduled for an inguinal hernia repair using one of three procedures (Lichtenstein, Barwell and TEP = total extraperitoneal hernioplasty) are being randomly allocated intra-operatively into two groups. Group I patients receive a local injection of 20 ml Carbostesin^®0.25% at the end of the operation according to a standardised procedure. Group II patients get a 20 ml placebo (0.9% Saline) injection. We use pre-filled identically looking syringes for blinded injection, i.e. the patient, the surgeon and the examinator who performs the postoperative clinical follow-ups remain unaware of group allocation. The primary outcome of the study is the occurrence of developing chronic pain (defined as persistent pain at 3 months FU) measured by VAS and Pain Matcher^®device (Cefar Medical AB, Lund, Sweden).</p> <p>The study started on July 2006. In addition to a sample size re-evaluation three interim analyses are planned after 120, 180 and 240 patients had finished their 3-months follow-up to allow for early study termination.</p> <p>Discussion</p> <p>Using a group sequential study design the minimum number of patients are enrolled to reach a valid conclusion before the end of the study.</p> <p>To limit subjectivity, both a VAS and the Pain Matcher^®device are used for the evaluation of pain. This allows us also to compare these two methods and further assess the use of Pain Matcher^®in clinical routine.</p> <p>The occurrence of chronic pain after inguinal hernia repair has been in focus of several clinical studies but the reduction of it has been rarely investigated. We hope to significantly reduce the occurrence of this complication with our investigated intervention.</p> <p>Trial Registration</p> <p>Our trial has been registered at ClinicalTrials.gov. The trial registration number is: [NCT00484731].</p