An interventional study of Transversus abdominis plane block (TAP block) and Rectus sheath block (active) in Inguinal Hernia, sponsored by Tampere University Hospital. Recruiting at 1 site in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-20.
Sponsored by Tampere University Hospital · Not applicable, Interventional, and Treatment
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.
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.
549 studies on the registry are indexed under Hernia, Inguinal; 74 are open to participants now.
This study's planned enrollment of 200 is above the median of 90 across 406 interventional studies indexed under Hernia, Inguinal.
Browse Hernia, Inguinal studies →Tampere University Hospital is the lead sponsor of 209 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
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
Ultrasound-guided transversus abdominis plane (TAP) block performed preoperatively using local anesthetic for postoperative analgesia.
Ultrasound-guided rectus sheath (RS) block performed preoperatively using local anesthetic for postoperative analgesia.
Ultrasound-guided sham block performed using saline to maintain blinding, without active local anesthetic.
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.
0.9% sodium chloride solution used as placebo in sham transversus abdominis plane (TAP) and rectus sheath (RS) blocks to maintain blinding.
Ultrasound guidance used to perform transversus abdominis plane (TAP) and rectus sheath (RS) blocks.
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.
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
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
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
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
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
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.
Time frame: Up to 24 hours
Presence of chronic postoperative pain
Presence of persistent postoperative pain assessed during follow-up using patient self-report.
Time frame: 1 week and 1, 3, 5, and 10 years after surgery
Plan to share: No
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Tampere University Hospital