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

NCT ID: NCT05444985

Last Updated: 2023-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-17
• Study Completion Date: 2023-05-09

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.

Conditions

Analgesia; Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

External Oblique Intercostal Block Group

While patients are still under general anesthesia, external oblique intercostal block (EOIB) will be performed bilaterally according to appropriate asepsis/antisepsis rules before awakening.

Group Type: EXPERIMENTAL

Pain Management

Intervention Type: OTHER

Regional anesthetic techniques for peri-operative pain management after surgery.

Control

Patients in the control group will not have any intervention concerning regional anesthesia.

Group Type: ACTIVE_COMPARATOR

Pain Management

Intervention Type: OTHER

Regional anesthetic techniques for peri-operative pain management after surgery.

Interventions

Pain Management

Regional anesthetic techniques for peri-operative pain management after surgery.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsun University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hatice Kusderci, M.D.

Role: PRINCIPAL_INVESTIGATOR

Samsun University

Locations

Samsun University

Samsun, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

HATICE55

Identifier Type: -

Identifier Source: org_study_id