Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07423910

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Inguinal Hernia Hernia Hernia, Abdominal Hernia, Inguinal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tampere University Hospital

Tampere, Finland

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Transversus abdominis plane block (TAP block)

Procedure

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

Rectus sheath block (active)

Procedure

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

Placebo nerve block

Procedure

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

Ropivacaine

Drug

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.

Sodium Chloride

Drug

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

Ultrasound device

Device

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

Morphine

Drug

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.

Primary outcomes

  1. Total cumulative opioid consumption (intravenous morphine equivalent dose, mg)

    Time frame: Perioperative/Periprocedural

    Total cumulative opioid dose administered intraoperatively and postoperatively, converted to intravenous morphine equivalent dose (mg) using standardized equianalgesic conversion factors.

Secondary outcomes

  1. Postoperative pain intensity (Numeric Rating Scale, NRS 0-10)

    Time frame: 1 hour and 24 hours after surgery

    Postoperative pain intensity assessed using a Numeric Rating Scale (NRS, 0-10), where 0 indicates no pain and 10 indicates worst imaginable pain.

  2. Number of participants requiring rescue analgesia within 24 hours

    Time frame: Up to 24 hours

    Number of participants requiring additional rescue analgesic medication due to inadequate pain control.

  3. Number of participants with postoperative nausea and/or vomiting

    Time frame: Up to 24 hours

    Occurrence of postoperative nausea and/or vomiting and need for antiemetic medication.

  4. Time to fulfillment of discharge criteria

    Time frame: Up to 24 hours

    Time from completion of surgery to fulfillment of predefined discharge criteria according to institutional day-surgery protocol

  5. Number of participants with unplanned hospital admission within 24 hours

    Time frame: Up to 24 hours

    Number of participants requiring unplanned hospital admission or prolonged hospital stay following planned day-case surgery.

  6. Presence of chronic postoperative pain

    Time frame: 1 week and 1, 3, 5, and 10 years after surgery

    Presence of persistent postoperative pain assessed during follow-up using patient self-report.

Study contacts

Contact information is provided by the study sponsor or research team.

Aki Lumme, MD

CONTACT

[email protected]

+358331167232

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Registry information

Official study title

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)

Acronym: PRO-RSTAP

Important dates

Study start
2025
Primary completion
2028
Study completion
2038
First posted
Feb 20, 2026
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.