Inguinal Hernia
Conditions
Keywords
Open inguinal hernia repair, Regional anesthesia, Transversus abdominis plane block, Rectus sheath block, Postoperative analgesia
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.
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.
Interventions
Ultrasound-guided transversus abdominis plane (TAP) block performed preoperatively using local anesthetic for postoperative analgesia.
PROCEDURERectus sheath block (active)
Ultrasound-guided rectus sheath (RS) block performed preoperatively using local anesthetic for postoperative analgesia.
PROCEDUREPlacebo nerve block
Ultrasound-guided sham block performed using saline to maintain blinding, without active local anesthetic.
DRUGRopivacaine
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.
DRUGSodium chloride
0.9% sodium chloride solution used as placebo in sham transversus abdominis plane (TAP) and rectus sheath (RS) blocks to maintain blinding.
DEVICEUltrasound device
Ultrasound guidance used to perform transversus abdominis plane (TAP) and rectus sheath (RS) blocks.
DRUGMorphine
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.
Sponsors
Tampere University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total cumulative opioid consumption (intravenous morphine equivalent dose, mg) | Perioperative/Periprocedural | Total cumulative opioid dose administered intraoperatively and postoperatively, converted to intravenous morphine equivalent dose (mg) using standardized equianalgesic conversion factors. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain intensity (Numeric Rating Scale, NRS 0-10) | 1 hour and 24 hours after surgery | Postoperative pain intensity assessed using a Numeric Rating Scale (NRS, 0-10), where 0 indicates no pain and 10 indicates worst imaginable pain. |
| Number of participants requiring rescue analgesia within 24 hours | Up to 24 hours | Number of participants requiring additional rescue analgesic medication due to inadequate pain control. |
| Number of participants with postoperative nausea and/or vomiting | Up to 24 hours | Occurrence of postoperative nausea and/or vomiting and need for antiemetic medication. |
| Time to fulfillment of discharge criteria | Up to 24 hours | Time from completion of surgery to fulfillment of predefined discharge criteria according to institutional day-surgery protocol |
| Number of participants with unplanned hospital admission within 24 hours | Up to 24 hours | Number of participants requiring unplanned hospital admission or prolonged hospital stay following planned day-case surgery. |
| Presence of chronic postoperative pain | 1 week and 1, 3, 5, and 10 years after surgery | Presence of persistent postoperative pain assessed during follow-up using patient self-report. |
Countries
Finland
Contacts
CONTACTAki Lumme, MD
PRINCIPAL_INVESTIGATORAki Lumme
Tampere University Hospital, Pirkanmaa Wellbeing Services County
Outcome results
None listed