Transversus abdominis plane (TAP) block versus standard analgesia for postoperative pain following open upper abdominal surgery through a midline incision: a protocol for a prospective randomized controlled trial.
Researchers
Jihen Krichen, Asma Sghaier, Slah Soui, Sihem Sendi, Maroua Naoui, Bilel Faidi, Khalil Ben Salah, Amine Felhi, Oumayma Khechini, Imen Bannour
Abstract
To determine whether bilateral ultrasound-guided subcostal transversus abdominis plane (TAP) block, added to standardized non-opioid multimodal analgesia, reduces early pain after open upper midline laparotomy. In this single-center, parallel-group randomized controlled superiority trial, 108 adults undergoing elective open upper abdominal surgery through a midline incision will be randomized 1:1 (stratified by procedure category) to TAP block (bupivacaine 0.25%, 30 mL per side, maximum 2.5 mg/kg) plus multimodal analgesia or multimodal analgesia alone. Outcome assessors and the statistician will be blinded; no sham block is used. The primary outcome is pain at rest on a 100-mm visual analog scale (VAS), averaged over 6, 12 and 24 h after surgery. Secondary outcomes include movement-evoked pain, Quality of Recovery-15 (QoR-15), consumption of each rescue analgesic, postoperative nausea and vomiting (PONV), time to ambulation, time to first flatus and adverse events (actively monitored until 48 h after surgery or hospital discharge, whichever is later). The primary effect will be estimated by intention-to-treat using a mixed model for repeated measures, as the equally weighted mean between-group difference with 95% confidence interval. This trial will quantify the incremental benefit of subcostal TAP block in a defined surgical population. Pan African Clinical Trials Registry (www.pactr.org) identifier is PACTR202608546707144. Pan African Clinical Trials Registry (PACTR; www.pactr.org), PACTR202608546707144, registered on 18 August 2026. Operations on the upper part of the abdomen through a long vertical cut are painful. Pain can stop patients from breathing deeply, getting out of bed and walking, and can slow the return of normal bowel function. In our hospital, pain after such operations is usually treated with medicines given through a drip or an injection, such as paracetamol, nefopam and ketoprofen.A transversus abdominis plane (TAP) block is an injection of local anesthetic (numbing medicine) into a layer between the muscles of the abdominal wall. The anesthetist guides the needle with an ultrasound scanner while the patient is already asleep. The numbing medicine may reduce pain in the skin and muscles around the wound for several hours.This study will include 108 adults having planned surgery through an upper vertical cut. By chance, like tossing a coin, half will receive the TAP block on both sides in addition to usual pain medicines, and half will receive usual pain medicines only. The staff who ask patients about their pain will not know which group they are in. We will compare pain scores during the first day after surgery, pain when coughing, the amount of extra pain medicine needed, sickness, the time to first walking and to passing wind, overall recovery, and any side effects. The results will help doctors decide whether this block is worth adding to routine care after this type of operation.Source: PubMed (PMID: 43008107)View Original on PubMed