RecruitingNot ApplicableNCT07423910

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)


Sponsor

Tampere University Hospital

Enrollment

200 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • Adults aged 18 years or older
  • Elective unilateral open inguinal hernia repair
  • Ability to provide written informed consent

Exclusion Criteria5

  • Emergency surgery
  • Bilateral or recurrent inguinal hernia
  • Contraindication to regional anesthesia or study interventions
  • Known allergy to local anesthetics
  • Inability to comply with study procedures

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Interventions

PROCEDURETransversus abdominis plane block (TAP block)

Ultrasound-guided transversus abdominis plane (TAP) block performed preoperatively using local anesthetic for postoperative analgesia.

PROCEDURERectus sheath block (active)

Ultrasound-guided rectus sheath (RS) block performed preoperatively using local anesthetic for postoperative analgesia.

PROCEDUREPlacebo nerve block

Ultrasound-guided sham block performed using saline to maintain blinding, without active local anesthetic.

DRUGRopivacaine

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.

DRUGSodium chloride

0.9% sodium chloride solution used as placebo in sham transversus abdominis plane (TAP) and rectus sheath (RS) blocks to maintain blinding.

DEVICEUltrasound device

Ultrasound guidance used to perform transversus abdominis plane (TAP) and rectus sheath (RS) blocks.

DRUGMorphine

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.


Locations(1)

Tampere University Hospital

Tampere, Finland

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NCT07423910


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