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

NCT ID: NCT06869837

Last Updated: 2026-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-08

Study Completion Date

2025-12-20

Brief Summary

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

Detailed Description

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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.

Conditions

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Pain Management Laparoscopic Cholecystectomy Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Group EOİPB

Bilateral External oblique intercostal plane block will be applied 45 minutes before surgery.

Group Type ACTIVE_COMPARATOR

Group EOİPB

Intervention Type OTHER

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

Group Control

No intervention will be made in this group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Group EOİPB

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsun University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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HALE K CELIK

Role: STUDY_DIRECTOR

SAMSUN UNİVERSITY

Locations

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Samsun University, Samsun Training and Research Hospital

Samsun, İ̇lkadim, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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OMUKAEK 2024/269

Identifier Type: -

Identifier Source: org_study_id

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