Transversus abdominis plane block under laparoscopic guide versus port-site local anaesthetic infiltration in laparoscopic excision of endometriosis: a double-blind randomised placebo-controlled trial.

OBJECTIVE: To compare the efficiency of laparoscopically guided transversus abdominis plane block (LTAP) versus port-site local anaesthetic infiltration (LAI) in reducing postoperative pain following laparoscopic excision of endometriosis. DESIGN: A prospective, double-blind randomised controlled trial. SETTING: A tertiary referral centre for endometriosis and minimally invasive gynaecological surgery. POPULATION: Women undergoing laparoscopic excision of endometriosis from December 2015 through July 2016. METHODS: Participants were randomised to receive: port-site infiltration with bupivacaine and placebo LTAP (LAI group, n = 21); placebo port-site infiltration and LTAP with bupivacaine (LTAP group, n = 24); placebo port-site infiltration and placebo LTAP (placebo group, n = 25). MAIN OUTCOME MEASURES: Post-operative pain at 2-4, 6-8, 10-12 and 24 hours, analgesic requirements, TAP block-related complications and opioid-related adverse effects. RESULTS: There were no differences in patient characteristics between the groups. In comparison with placebo, both LTAP and LAI groups had significantly less pain at 2-4, 6-8, and 10-12 hours (median 3, 3, 3.5 versus 3, 6, 4 versus 8, 8, 7 for LTAP, LAI, and placebo, respectively, P < 0.05). Median differences (and 95% confidence intervals) were as follows; LTAP versus placebo -5 (-6 to -4), -4 (-5 to -3), -3 (-4 to -0.5); LAI versus placebo -4 (-5 to -2), -2 (-3 to -0.5), -1 (-4 to -0.5) at 2-4, 6-8 and 10-12 hours, respectively. There were no statistically significant differences between the LTAP and LAI groups. CONCLUSIONS: Laparoscopically guided transversus abdominis plane block and LAI both reduce postoperative pain in patients undergoing laparoscopic excision of endometriosis, compared with placebo. We found no differences in effect between LTAP and LAI. TWEETABLE ABSTRACT: TAP block and port-site local infiltration are both effective in reducing postoperative pain in major gynaecological laparoscopic surgery.

The randomised uterine septum transsection trial (TRUST): design and protocol.

BACKGROUND: A septate uterus is a uterine anomaly that may affect reproductive outcome, and is associated with an increased risk for miscarriage, subfertility and preterm birth. Resection of the septum is subject of debate. There is no convincing evidence concerning its effectiveness and safety. This study aims to assess whether hysteroscopic septum resection improves reproductive outcome in women with a septate uterus. METHODS/DESIGN: A multi-centre randomised controlled trial comparing hysteroscopic septum resection and expectant management in women with recurrent miscarriage or subfertility and diagnosed with a septate uterus. The primary outcome is live birth, defined as the birth of a living foetus beyond 24 weeks of gestational age. Secondary outcomes are ongoing pregnancy, clinical pregnancy, miscarriage and complications following hysteroscopic septum resection. The analysis will be performed according to the intention to treat principle. Kaplan-Meier curves will be constructed, estimating the cumulative probability of conception leading to live birth rate over time. Based on retrospective studies, we anticipate an improvement of the live birth rate from 35% without surgery to 70% with surgery. To demonstrate this difference, 68 women need to be randomised. DISCUSSION: Hysteroscopic septum resection is worldwide considered as a standard procedure in women with a septate uterus. Solid evidence for this recommendation is lacking and data from randomised trials is urgently needed. TRIAL REGISTRATION: Dutch trial registry ( NTR1676 , 18th of February 2009).