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

ConditionInguinal Hernia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTampere University Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18 years or older

Elective unilateral open inguinal hernia repair

Ability to provide written informed consent

Disqualifiers

Emergency surgery

Bilateral or recurrent inguinal hernia

Contraindication to regional anesthesia or study interventions

Known allergy to local anesthetics

Trial design

Design model

Factorial

Treatments tested in this trial

  • Transversus abdominis plane block (TAP block)

    Procedure/Surgery

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

  • Rectus sheath block (active)

    Procedure/Surgery

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

  • Placebo nerve block

    Procedure/Surgery

    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.

Treatment groups

200 Participants
are divided into 4 treatment groups
Group A: Combined TAP + RS blockExperimental treatment 5 interventions
Group B: TAP block onlyExperimental treatment 6 interventions
Group C: RS block onlyExperimental treatment 6 interventions
Group D: Placebo TAP + Placebo RSPlacebo comparator 4 interventions

Trial outcomes

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.

Time frame
Perioperative/Periprocedural

Secondary outcomes

1

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.

Time frame
1 hour and 24 hours after surgery
2

Number of participants requiring rescue analgesia within 24 hours

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

Time frame
Up to 24 hours
3

Number of participants with postoperative nausea and/or vomiting

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

Time frame
Up to 24 hours
4

Time to fulfillment of discharge criteria

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

Time frame
Up to 24 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tampere University Hospital

Lead sponsor

Source ClinicalTrials.gov
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