Comparison of OSTAP and EOIP Blocks in Laparoscopic Cholecystectomies

Not Applicable

Completed

• Conditions: Pain, Post Operative; Analgesia
• Interventions: Other: EOIP; Other: OSTAP

• Registration Number: NCT06172465
• Lead Sponsor: Samsun University

Brief Summary

Laparoscopic cholecystectomy (LC) surgery causes postoperative severe pain. As part of multimodal analgesia aimed at reducing postoperative opioid consumption and providing effective analgesia, ultrasound (US)-guided transversus abdominis plane block (TAP) and external oblique intercostal plane block (EOIPB) will be applied as regional anesthesia methods. There is no study in the literature comparing OSTAP and EOIP blocks, and our goal is to evaluate the analgesic effectiveness between OSTAP and EOIP blocks in LC surgeries.

Detailed Description

Patients will be divided into two groups, and general anesthesia will be administered to all. Before extubation, one group will receive an external oblique intercostal nerve block, while the other group will receive an oblique subcostal transversus abdominis plane block. The randomization of the study will be carried out by a computer-generated randomization code (computer-generated) by a physician who will not be involved in patient follow-up. The interfascial plane block (either external oblique intercostal block or oblique subcostal block) will be provided to an anesthesiologist in a sealed envelope by an independent assistant staff member outside the study. The patient will not be aware of which block is applied. The anesthesiologist performing the block will not participate in the pain follow-up of the patients. Postoperative pain assessment and data collection will be conducted by another anesthesiologist unaware of the study.

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

Study Timeline

• Study First Submitted: 2023-12-07
• Study First Submitted QC: 2023-12-07
• Study First Posted: 2023-12-15
• Study Start: 2024-01-05
• Status Verified: 2024-11
• Primary Completion: 2024-11-24
• Study Completion: 2024-11-25
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-27

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
group external oblique intercostal plane block	EOIP	While patients are still under general anesthesia, external oblique intercostal block (EOIB) will be performed bilaterally according to appropriate asepsis/antisepsis rules at end of the surgery.
group oblique subcostal transversus abdominis plane block	OSTAP	Ultrasound-guided bilateral OSTAP block performed at end of the surgery. Perioperative and postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block) Standard Pain Followup and Monitorization will be performed

Primary Outcome Measures

Name	Time	Method
Postoperative opioid consumption	up to 24 hours	tramadol consumption in the first 24 hours after surgery

Secondary Outcome Measures

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