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

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.

Study Overview

• Status: Recruiting
• Conditions: Inguinal Hernia
• Intervention / Treatment: Procedure: Transversus abdominis plane block (TAP block); Procedure: Rectus sheath block (active); Drug: Ropivacaine; Device: Ultrasound device; Drug: Morphine; Procedure: Placebo nerve block; Drug: Sodium chloride

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aki Lumme, MD; Phone Number: +358331167232; Email: aki.lumme@pirha.fi

Study Locations

• Finland
  • Tampere, Finland
    • Recruiting
    • Tampere University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combined TAP + RS block; Participants receive active TAP block and active RS block in addition to standard perioperative care.	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.; 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.; 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.
Experimental: TAP block only; Participants receive active TAP block and placebo RS block in addition to standard perioperative care.	Procedure: Transversus abdominis plane block (TAP block); Ultrasound-guided transversus abdominis plane (TAP) block performed preoperatively using local anesthetic for postoperative analgesia.; 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.; 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.; Procedure: Placebo nerve block; Ultrasound-guided sham block performed using saline to maintain blinding, without active local anesthetic.; 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.
Experimental: RS block only; Participants receive active RS block and placebo TAP block in addition to standard perioperative care.	Procedure: Rectus sheath block (active); Ultrasound-guided rectus sheath (RS) block performed preoperatively using local anesthetic for postoperative analgesia.; 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.; 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.; Procedure: Placebo nerve block; Ultrasound-guided sham block performed using saline to maintain blinding, without active local anesthetic.; 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.
Placebo Comparator: Placebo TAP + Placebo RS; Participants receive placebo transversus abdominis plane (TAP) block and placebo rectus sheath (RS) block in addition to standard perioperative care.	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.; Procedure: Placebo nerve block; Ultrasound-guided sham block performed using saline to maintain blinding, without active local anesthetic.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain intensity (Numeric Rating Scale, NRS 0-10)	Postoperative pain intensity assessed using a Numeric Rating Scale (NRS, 0-10), where 0 indicates no pain and 10 indicates worst imaginable pain.	1 hour and 24 hours after surgery
Number of participants requiring rescue analgesia within 24 hours	Number of participants requiring additional rescue analgesic medication due to inadequate pain control.	Up to 24 hours
Number of participants with postoperative nausea and/or vomiting	Occurrence of postoperative nausea and/or vomiting and need for antiemetic medication.	Up to 24 hours
Time to fulfillment of discharge criteria	Time from completion of surgery to fulfillment of predefined discharge criteria according to institutional day-surgery protocol	Up to 24 hours
Number of participants with unplanned hospital admission within 24 hours	Number of participants requiring unplanned hospital admission or prolonged hospital stay following planned day-case surgery.	Up to 24 hours
Presence of chronic postoperative pain	Presence of persistent postoperative pain assessed during follow-up using patient self-report.	1 week and 1, 3, 5, and 10 years after surgery

Collaborators and Investigators

• Sponsor: Tampere University Hospital
• Investigators: Principal Investigator: Aki Lumme, Tampere University Hospital, Pirkanmaa Wellbeing Services County

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2038

Study Registration Dates

• First Submitted: February 6, 2026
• First Submitted That Met QC Criteria: February 13, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Postoperative analgesia; Regional anesthesia; Transversus abdominis plane block; Rectus sheath block; Open inguinal hernia repair
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia; Hernia, Abdominal; Pathological Conditions, Signs and Symptoms; Hernia, Inguinal; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Diagnostic Techniques and Procedures; Diagnosis; Alkaloids; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Anilides; Amides; Aniline Compounds; Amines; Inorganic Chemicals; Chlorine Compounds; Diagnostic Imaging; Heterocyclic Compounds, 4 or More Rings; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, Bridged-Ring; Phenanthrenes; Morphine Derivatives; Sodium Compounds; Chlorides; Hydrochloric Acid; Ropivacaine; Morphine; Exercise; Ultrasonography; Sodium Chloride
• Other Study ID Numbers: R24107M; 2024-513406-59-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No