NCT07423910

PRO-RSTAP: Effect of TAP and RS Blocks on Recovery After Inguinal Hernia Surgery (PRO-RSTAP)

Effect of Medial Transversus Abdominis Plane (TAP) Block and Rectus Sheath (RS) Block on Inguinal Hernia Surgery Recovery, a Prospective Randomized Double-blind Study (PRO-RSTAP)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Tampere University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Inguinal hernia repair is a common surgical procedure, often performed as day-case surgery. Despite standardized surgical techniques, postoperative pain may delay recovery and occasionally lead to unplanned hospital admission. The PRO-RSTAP study is a prospective, randomized, double-blind clinical trial evaluating whether ultrasound-guided transversus abdominis plane (TAP) block, rectus sheath (RS) block, or their combination improves postoperative recovery after open inguinal hernia surgery. Adult patients undergoing unilateral open inguinal hernia repair are randomized into four groups receiving either combined TAP and RS blocks, TAP block only, RS block only, or placebo blocks , in addition to standard perioperative care. The primary outcome is total perioperative opioid consumption measured as intravenous morphine equivalents. Secondary outcomes include postoperative pain scores, need for rescue analgesia, postoperative nausea and vomiting, time to discharge, unplanned hospital admission, and chronic postoperative pain during long-term follow-up. The aim of this study is to determine the individual and combined effects of TAP and RS blocks on postoperative analgesia and recovery in patients undergoing open inguinal hernia repair.

Detailed description

This study is a prospective, randomized, double-blind clinical trial evaluating the effects of ultrasound-guided transversus abdominis plane (TAP) block and rectus sheath (RS) block on postoperative recovery after open inguinal hernia surgery. The study uses a 2 × 2 factorial design, with participants randomized into four groups receiving combined TAP and RS blocks, TAP block only, RS block only, or placebo blocks, in addition to standard perioperative care. The primary outcome is total perioperative opioid consumption measured as intravenous morphine equivalent dose. Secondary outcomes include postoperative pain intensity, need for rescue analgesia, postoperative nausea and vomiting, time to discharge, and unplanned hospital admission.

Conditions

• Inguinal Hernia

Interventions

Type	Name	Description
PROCEDURE	Transversus abdominis plane block (TAP block)	Ultrasound-guided transversus abdominis plane (TAP) block performed preoperatively using local anesthetic for postoperative analgesia.
PROCEDURE	Rectus sheath block (active)	Ultrasound-guided rectus sheath (RS) block performed preoperatively using local anesthetic for postoperative analgesia.
PROCEDURE	Placebo nerve block	Ultrasound-guided sham block performed using saline to maintain blinding, without active local anesthetic.
DRUG	Ropivacaine	Ropivacaine 7.5 mg/ml diluted 1:1 with saline, used for active transversus abdominis plane (TAP) and/or rectus sheath (RS) blocks administered preoperatively for postoperative analgesia.
DRUG	Sodium chloride	0.9% sodium chloride solution used as placebo in sham transversus abdominis plane (TAP) and rectus sheath (RS) blocks to maintain blinding.
DEVICE	Ultrasound device	Ultrasound guidance used to perform transversus abdominis plane (TAP) and rectus sheath (RS) blocks.
DRUG	Morphine	Standard perioperative opioid analgesics administered intraoperatively and postoperatively according to institutional protocol. Opioid doses are recorded and converted to intravenous morphine equivalent dose for outcome assessment.

Timeline

• Start date: 2025-07-01
• Primary completion: 2028-01-01
• Completion: 2038-01-01
• First posted: 2026-02-20
• Last updated: 2026-02-20

Locations

1 site across 1 country: Finland