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

6 juni 2026 uppdaterad av: İsmet Uluhan, Ankara Etlik City Hospital

Comparison of M-TAPA and External Oblique Intercostal Plane Block on Intraoperative Analgesia and Opioid Consumption Guided by Skin Conductance Algesimeter in Laparoscopic Cholecystectomy

This prospective observational study is designed to evaluate the effects of modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) and external oblique intercostal (EOI) plane block on intraoperative analgesia and opioid consumption in patients undergoing elective laparoscopic cholecystectomy. Abdominal wall blocks are widely used to improve perioperative analgesia; however, their impact on intraoperative opioid requirements when guided by objective nociception monitoring remains unclear.

All patients will receive standardized general anesthesia. Intraoperative analgesia will be 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)" will be used to assess nociceptive responses. Remifentanil infusion will be titrated according to SCA values to maintain adequate analgesia. Dose adjustments will be performed at predefined intervals, and changes will be considered valid only if sustained for a minimum duration.

Patients will receive either M-TAPA or EOI block as part of routine clinical practice. The choice of block will not be influenced by the investigators, in accordance with the observational design of the study. Data will be collected prospectively during the intraoperative period and postoperative follow-up.

The primary outcome of the study is the time-weighted average intraoperative remifentanil infusion rate (µg/kg/min). Secondary outcomes include total intraoperative remifentanil consumption (µg/kg), intraoperative hemodynamic parameters (heart rate and mean arterial pressure), frequency of deviations in SCA values from the target range, postoperative pain scores assessed using a numeric rating scale (NRS), time to first analgesic requirement, and total rescue analgesic consumption.

Perioperative analgesia will be standardized. All patients will receive intravenous dexketoprofen toward the end of surgery as part of routine clinical practice. Rescue analgesia will be provided with intravenous dexketoprofen when clinically indicated. Additional outcomes include postoperative nausea and vomiting and perioperative complications.

This study aims to provide objective data on the opioid-sparing effects of different abdominal wall block techniques when intraoperative analgesia is guided by nociception monitoring. The findings may contribute to optimizing analgesic strategies and improving perioperative pain management in laparoscopic surgery.

Studieöversikt

Status

Rekrytering

Betingelser

Detaljerad beskrivning

This prospective observational study evaluates intraoperative opioid requirements under nociception-guided analgesia in patients undergoing elective laparoscopic cholecystectomy. Analgesic management is guided by the Skin Conductance Algesimeter (SCA), which reflects sympathetic activation through fluctuations in palmar skin conductance. The SCA-derived parameter "peaks per second (PPS)" is used as a real-time surrogate of nociceptive activity.

General anesthesia is administered according to institutional standards. Remifentanil is delivered via continuous infusion and titrated in response to SCA values to maintain a predefined nociception-analgesia balance. Dose adjustments are performed in stepwise increments, with changes considered valid only if sustained over a defined period. Hemodynamic variables are monitored concurrently but are not the primary determinants of opioid titration.

Abdominal wall analgesia is provided using either modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) or external oblique intercostal (EOI) plane block, both applied as part of routine clinical practice. In line with the observational design, no allocation or intervention is performed by the investigators, and block selection is based on standard clinical decision-making.

Intraoperative data are recorded at fixed time intervals, including heart rate, mean arterial pressure, SCA-derived PPS values, and remifentanil infusion rates. The primary endpoint is the time-weighted average remifentanil infusion rate (µg/kg/min), reflecting overall intraoperative opioid requirement normalized to surgical duration. Secondary analyses include total opioid exposure, frequency and magnitude of deviations from target nociception ranges, and perioperative analgesic requirements.

Intravenous dexketoprofen is administered toward the end of surgery as part of routine clinical care. Postoperative outcomes include pain intensity assessed using a numeric rating scale (NRS), time to first analgesic request, and additional analgesic consumption. Postoperative nausea, vomiting, and perioperative adverse events are also recorded.

This study aims to characterize the relationship between nociception-guided opioid titration and regional anesthesia techniques, and to determine the relative contribution of abdominal wall blocks to intraoperative opioid sparing under objective monitoring conditions.

Studietyp

Observationell

Inskrivning (Beräknad)

80

Kontakter och platser

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Studiekontakt

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Adult patients undergoing elective laparoscopic cholecystectomy under general anesthesia at a tertiary care hospital.

Beskrivning

Inclusion Criteria:

  • Patients aged 18-80 years
  • ASA physical status I-III
  • Scheduled for elective laparoscopic cholecystectomy under general anesthesia
  • Ability to provide written informed consent

Exclusion Criteria:

  • Patient refusal
  • Known allergy to local anesthetics
  • Chronic opioid use or opioid dependence
  • Neurological or psychiatric disorders affecting pain perception
  • Use of medications affecting autonomic nervous system activity, such as beta-blockers
  • Infection at the injection site
  • Coagulopathy or anticoagulant therapy
  • Pregnancy

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
M-TAPA Group
Patients receiving ePatients receiving modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) for intraoperative analgesia during laparoscopic cholecystectomy.ternal oblique intercostal plane block (EOI) for analgesia
EOI Group
Patients receiving external oblique intercostal plane (EOI) block for intraoperative analgesia during laparoscopic cholecystectomy.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Time-Weighted Mean Intraoperative Remifentanil Infusion Rate
Tidsram: Intraoperative period (from induction to end of surgery)
The time-weighted mean intraoperative remifentanil infusion rate will be calculated throughout the surgical period and expressed as micrograms per kilogram per minute (µg/kg/min) based on continuous infusion data.
Intraoperative period (from induction to end of surgery)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Postoperative Pain Scores Assessed by Numeric Rating Scale
Tidsram: 0, 2, 4, 6, 12, and 24 hours postoperatively
Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain. Assessments will be performed at rest and during movement.
0, 2, 4, 6, 12, and 24 hours postoperatively
Time to First Analgesic Requirement
Tidsram: Within 24 hours postoperatively
Time to First Analgesic Requirement
Within 24 hours postoperatively
Rescue Analgesic Consumption
Tidsram: First 24 hours postoperatively
Total amount of rescue analgesic (dexketoprofen) administered within the first 24 hours postoperatively.
First 24 hours postoperatively
Mean Arterial Pressure
Tidsram: Intraoperative period
Mean arterial pressure (MAP), expressed in mmHg, will be recorded intraoperatively and compared with baseline values.
Intraoperative period
Heart Rate
Tidsram: Intraoperative period
Heart rate, expressed as beats per minute, will be recorded intraoperatively and compared with baseline values.
Intraoperative period
Skin Conductance Algesimeter(SCA)
Tidsram: Intraoperative period
Skin Conductance Algesimeter (SCA) peaks per second (PPS) values recorded intraoperatively to assess nociceptive responses.
Intraoperative period
Postoperative Nausea and Vomiting (PONV)
Tidsram: First 24 hours postoperatively
Incidence of postoperative nausea and vomiting within the first 24 hours after surgery.
First 24 hours postoperatively

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Ankara Etlik City Hospital

Publikationer och användbara länkar

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Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

15 maj 2026

Primärt slutförande (Beräknad)

1 augusti 2026

Avslutad studie (Beräknad)

1 september 2026

Studieregistreringsdatum

Först inskickad

5 maj 2026

Först inskickad som uppfyllde QC-kriterierna

15 maj 2026

Första postat (Faktisk)

19 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

9 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • AEŞH-EK-2026-019

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

Individual participant data will not be shared in accordance with institutional policies

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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