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

Официальное название

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)

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Transversus abdominis plane block (TAP block)
  Ultrasound-guided transversus abdominis plane (TAP) block performed preoperatively using local anesthetic for postoperative analgesia.
• Процедура Rectus sheath block (active)
  Ultrasound-guided rectus sheath (RS) block performed preoperatively using local anesthetic for postoperative analgesia.
• Процедура Placebo nerve block
  Ultrasound-guided sham block performed using saline to maintain blinding, without active local anesthetic.
• Препарат 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.
• Препарат Sodium chloride
  0.9% sodium chloride solution used as placebo in sham transversus abdominis plane (TAP) and rectus sheath (RS) blocks to maintain blinding.
• Устройство Ultrasound device
  Ultrasound guidance used to perform transversus abdominis plane (TAP) and rectus sheath (RS) blocks.
• Препарат 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.

Первичные конечные точки

• Total cumulative opioid consumption (intravenous morphine equivalent dose, mg) [Срок оценки: Perioperative/Periprocedural]

Вторичные конечные точки (6)

• Postoperative pain intensity (Numeric Rating Scale, NRS 0-10) [Срок оценки: 1 hour and 24 hours after surgery]
• Number of participants requiring rescue analgesia within 24 hours [Срок оценки: Up to 24 hours]
• Number of participants with postoperative nausea and/or vomiting [Срок оценки: Up to 24 hours]
• Time to fulfillment of discharge criteria [Срок оценки: Up to 24 hours]
• Number of participants with unplanned hospital admission within 24 hours [Срок оценки: Up to 24 hours]
• Presence of chronic postoperative pain [Срок оценки: 1 week and 1, 3, 5, and 10 years after surgery]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Финляндия · 1 центр

• Tampere University Hospital — Tampere

Публикации

• Nordstrom P, Lumme A, Virman J, Kalliomaki ML. Combined Transversus Abdominis Plane and Rectus Sheath Blocks in Open Inguinal Hernia Repair: Protocol for a Double-Blind Randomized Controlled Trial (PRO-RSTAP). Acta Anaesthesiol Scand. 2026 Jul;70(6):e70238. doi: 10.1111/aas.70238. PMID 42089120

Идентификаторы

NCT: NCT07423910 · R24107M · 2024-513406-59-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗