Postoperative Analgesic Effects of Bilateral External Oblique Intercostal Block in Laparoscopic Cholecystectomy Surgery

Not Applicable

Completed

• Conditions: Analgesia; Pain, Postoperative
• Interventions: Other: Pain Management

• Registration Number: NCT05444985
• Lead Sponsor: Samsun University

Brief Summary

The aim of our study is to reduce postoperative pain by performing external oblique intercostal block in L/S cholecystectomy surgeries. Our main goal is to provide well managed post-operative analgesia.

Detailed Description

The patients will be divided into two groups and general anesthesia will be applied to all of them. There will be no regional anesthetic technique to be performed, on the other hand, external oblique intercostal nerve block will be applied to patients in the other group before the patients are extubated. Study randomization is done with computer-generated randomization codes (computer-generated) by a physician who will not participate in patient follow-up. Interfascial plane block (external oblique intercostal block) will be given to the anesthesiologist in a sealed envelope by an independent assistant staff outside the study, the patient will not know which block is applied. The anesthetist who made the block will not participate in the pain follow-up of the patients. Postoperative pain assessment and data collection will be performed by another anesthetist blinded to the study.

For the standardization, the block procedure will be performed by an experienced anesthesiologist who has performed at least 20 previous successful and uncomplicated procedures.

Study Timeline

• Study First Submitted: 2022-06-28
• Study First Submitted QC: 2022-07-01
• Study First Posted: 2022-07-06
• Study Start: 2022-07-17
• Primary Completion: 2023-05-09
• Study Completion: 2023-05-09
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-20
• Last Update Posted: 2023-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• BMI < 35 kg/m²
• Patients with ASA scores I and II

Exclusion Criteria

• Patients who do not want to be included in the study
• Psychiatric and neurological disease with blurred consciousness
• Patients with ASA > 3
• BMI > 35 kg/m²
• Abnormality in coagulation parameters
• History of allergy to local anesthetic drugs
• Infection at the injection site

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Pain Management	Patients in the control group will not have any intervention concerning regional anesthesia.
External Oblique Intercostal Block Group	Pain Management	While patients are still under general anesthesia, external oblique intercostal block (EOIB) will be performed bilaterally according to appropriate asepsis/antisepsis rules before awakening.

Primary Outcome Measures

Name	Time	Method
Postoperative opioid consumption	24 hours	Contramal consumption in the first 24 hours after surgery

Secondary Outcome Measures

Name	Time	Method
NRS scores	At 1,3, 6, 12, 18, 24 hours	NRS scores in the first 24 hours after surgery
Quality of recovery	24 hours	QR15 scores
Nausea and vomiting	At 1,3, 6, 12, 18, 24 hours	Nausea and vomiting scores in the first 24 hours

Trial Locations

Locations (1)

Samsun University; 🇹🇷 Samsun, Turkey