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

NCT07423910 | Recruiting

• 2 other identifiers: R24107M2024-513406-59-00
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inguinal Hernia

Keywords

Open inguinal hernia repair; Regional anesthesia; Transversus abdominis plane block; Rectus sheath block; Postoperative analgesia

Outcome Measures

Primary Outcomes (1)

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

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

  Perioperative/Periprocedural

Secondary Outcomes (6)

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

  1 hour and 24 hours after surgery

• Number of participants requiring rescue analgesia within 24 hours

  Up to 24 hours

• Number of participants with postoperative nausea and/or vomiting

  Up to 24 hours

• Time to fulfillment of discharge criteria

  Up to 24 hours

• Number of participants with unplanned hospital admission within 24 hours

  Up to 24 hours

Study Arms (4)

Combined TAP + RS block

EXPERIMENTAL

Participants receive active TAP block and active RS block in addition to standard perioperative care.

Procedure: Transversus abdominis plane block (TAP block); Procedure: Rectus sheath block (active); Drug: Ropivacaine; Device: Ultrasound device; Drug: Morphine

TAP block only

EXPERIMENTAL

Participants receive active TAP block and placebo RS block in addition to standard perioperative care.

Procedure: Transversus abdominis plane block (TAP block); Procedure: Placebo nerve block; Drug: Ropivacaine; Drug: Sodium chloride; Device: Ultrasound device; Drug: Morphine

RS block only

EXPERIMENTAL

Participants receive active RS block and placebo TAP block in addition to standard perioperative care.

Procedure: Rectus sheath block (active); Procedure: Placebo nerve block; Drug: Ropivacaine; Drug: Sodium chloride; Device: Ultrasound device; Drug: Morphine

Placebo TAP + Placebo RS

PLACEBO COMPARATOR

Participants receive placebo transversus abdominis plane (TAP) block and placebo rectus sheath (RS) block in addition to standard perioperative care.

Procedure: Placebo nerve block; Drug: Sodium chloride; Device: Ultrasound device; Drug: Morphine

Interventions

Transversus abdominis plane block (TAP block) PROCEDURE

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

Combined TAP + RS block; TAP block only

Rectus sheath block (active) PROCEDURE

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

Combined TAP + RS block; RS block only

Placebo nerve block PROCEDURE

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

Placebo TAP + Placebo RS; RS block only; TAP block only

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.

Combined TAP + RS block; RS block only; TAP block only

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.

Placebo TAP + Placebo RS; RS block only; TAP block only

Ultrasound device DEVICE

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

Combined TAP + RS block; Placebo TAP + Placebo RS; RS block only; TAP block only

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.

Combined TAP + RS block; Placebo TAP + Placebo RS; RS block only; TAP block only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tampere University Hospital: lead

Study Sites (1)

Tampere University Hospital

Tampere, Finland

RECRUITING

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Exercise; Ropivacaine; Sodium Chloride; Ultrasonography; Morphine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Aki Lumme

  Tampere University Hospital, Pirkanmaa Wellbeing Services County

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aki Lumme, MD

CONTACT

+358331167232; aki.lumme@pirha.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a 2 × 2 factorial randomized study evaluating the individual and combined effects of rectus sheath (RS) block and transversus abdominis plane (TAP) block. Participants are randomized into four groups receiving combined RS and TAP blocks, TAP block only, RS block only, or placebo blocks.

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 20, 2026
• Study Start: July 1, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2038
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)