Skip to main content
OpenTrials
Completed

NCT Number: NCT06869837

EOIPB in Laparoscopic Cholecystectomy: Impact on Opioid Consumption Guided by ANI and Analgesia Quality

The aim of the study was to evaluate the response of regional anesthesia to remifentanyl consumption in patients undergoing laparoscopic cholecystectomy surgery.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain Management Agnosia Laparoscopic Cholecystectomy Surgery Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsun University, Samsun Training and Research Hospital

Samsun, İ̇lkadim, Turkey (Türkiye)

About this study

Routine anesthesia and analgesia protocol will be applied to all participants. The study aims to evaluate the remifentanyl consumption of the participants by dividing them into two groups as those with and without block and then performing their monitoring (pulse, mean arterial pressure with noninvasive measurement, oxygen saturation, Analgesia Nociception Index, Bispectral index). Remifentanil level will be adjusted according to the ANI value. The target is to keep the ANI between 50-70.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants who will undergo elective laparoscopic cholecystectomy surgery,
  • Age 18-70,
  • ASA I-II physical status,
  • Body mass index (BMI) < 35 kg/m²,
  • Participants who have written consent to participate in the study

Exclusion criteria

  • Participants with routine analgesic consumption,
  • Those with coagulopathy,
  • Those with a history of local anesthetic allergy,
  • Those with cardiac arrhythmia and pacemaker,
  • ASA III and above, Those with dementia

Treatment and study plan

Group EOİPB

Other

Bilateral external oblique intercostal plane block under USG guidance will be applied 45 minutes before cholecystectomy surgery.

Primary outcomes

  1. Intraoperative opioid consumption

    Time frame: During surgery

    Total amount of remifentanil consumed during cholecystectomy surgery

Secondary outcomes

  1. Numeric rating scale for postoperative pain intensity

    Time frame: up to 24 hours (Will be evaluated at 1, 3, 6, 9, 12, 18, 24 hours)

    Evaluated with a Numerical rating scale (NRS) from 0 to 10. (0=no pain; 10=worst imaginable pain)

  2. Quality of Recovery - 15 score

    Time frame: Postoperative 24th hour

    The impact of surgical and anesthetic interventions on perioperative quality of life and ability to resume routine life activities will be assessed using the Quality of Recovery (QoR) tool. Each question is scored between 0 and 10. The survey result varies between 0-150 points based on the answers given by the patients. Higher scores indicate better recovery.

  3. Fentanyl consumption at 30 minutes after arrival in the PACU(post anesthesia care unit)

    Time frame: 30 minutes

    Evaluated with a NRS from 0 to 10 and fentanyl will be administered when NRS is 4 and above. Fentanyl consumed will be recorded.

Sponsors and collaborators

Lead sponsor

Samsun University

Other

Registry information

Official study title

Effects of External Oblique Intercostal Plane Block Applied in Laparoscopic Cholecystectomy Surgery on Intraoperative Opioid ConsumptionDetermined by ANI (Analgesia Nociceptive Index) and Postoperative Analgesia Quality Guide; A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 11, 2025
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.