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

NCT06869837 | Completed

• 1 other identifier: OMUKAEK 2024/269
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain Management; Laparoscopic Cholecystectomy Surgery

Keywords

external oblique intercostal plane block

Outcome Measures

Primary Outcomes (1)

• Intraoperative opioid consumption

  Total amount of remifentanil consumed during cholecystectomy surgery

  During surgery

Secondary Outcomes (3)

• Numeric rating scale for postoperative pain intensity

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

• Quality of Recovery - 15 score

  Postoperative 24th hour

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

  30 minutes

Study Arms (2)

Group EOİPB

ACTIVE COMPARATOR

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

Other: Group EOİPB

Group Control

NO INTERVENTION

No intervention will be made in this group.

Interventions

Group EOİPB OTHER

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

Group EOİPB

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsun University: lead

Study Sites (1)

Samsun University, Samsun Training and Research Hospital

Samsun, İ̇lkadim, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• HALE K CELIK

  SAMSUN UNİVERSITY

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 11, 2025
• Study Start: April 8, 2025
• Primary Completion: December 15, 2025
• Study Completion: December 20, 2025
• Last Updated: January 6, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)