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Comparison of M-TAPA and External Oblique Intercostal Block for Intraoperative Opioid Consumption in Laparoscopic Cholecystectomy

Study acronym: MTAPA-EOI
StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Notable Phase changed: not specified → not applicable Show 9 more changesShow less
    • Trial completed
    • Interventions modified
    • Primary completion date changed from estimate of Aug 2026 to Aug 31, 2026
    • Study completion date changed from estimate of Sep 2026 to Sep 1, 2026
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 1 of 7 entries
    • Study description expanded, about 13 words
    • Site details revised
    • Publications: details revised at 3 of 3 entries
  2. Notable Recruitment opened
    • Study sites: 0 to 1
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This prospective, randomized, interventional study compares the effects of modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) and external oblique intercostal plane block (EOI) on intraoperative analgesia and opioid consumption in patients undergoing elective laparoscopic cholecystectomy. Eighty patients are randomized into two groups: the M-TAPA group and the EOI group. All patients receive standardized general anesthesia. Intraoperative analgesia is guided using the Skin Conductance Algesimeter (SCA), which reflects sympathetic nervous system activity by measuring fluctuations in skin conductance. The SCA parameter "peaks per second (PPS)" is used to assess nociceptive responses, and remifentanil infusion is titrated according to SCA values. Patients assigned to the M-TAPA group receive bilateral ultrasound-guided M-TAPA block, while patients assigned to the EOI group receive bilateral ultrasound-guided external oblique intercostal plane block. In both groups, 20 mL of 0.25% bupivacaine is administered on each side. Perioperative analgesia is standardized. All patients receive intravenous dexketoprofen toward the end of surgery. During postoperative follow-up, intravenous paracetamol is administered as rescue analgesia when the numeric rating scale (NRS) pain score is 4 or higher. The primary outcome is the time-weighted average intraoperative remifentanil infusion rate (µg/kg/min). Secondary outcomes include total intraoperative remifentanil consumption, intraoperative hemodynamic parameters, SCA measurements, postoperative pain scores, time to first rescue analgesic requirement, rescue analgesic consumption, postoperative nausea and vomiting, and perioperative complications. The study aims to compare the opioid-sparing and analgesic effects of M-TAPA and EOI under objective nociception-guided intraoperative analgesia.
Trial Details
NCT Number NCT07595679
Lead Sponsor Ankara Etlik City Hospital
Conditions
(from sponsor)
Laparoscopic Cholecystectomy Surgery, Perioperative Analgesia
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov