Comparison of OSTAP and EOIP Blocks in Laparoscopic Cholecystectomies

Comparison of Bilateral Oblique Transversus Abdominis Plane Block (OSTAPB) and Bilateral External Oblique Intercostal Plane Block (EOIPB) in Laparoscopic Cholecystectomies

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.

Study Overview

• Status: Completed
• Conditions: Analgesia; Pain, Post Operative
• Intervention / Treatment: Other: EOIP; Other: OSTAP

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ilkadım
    • Samsun, Ilkadım, Turkey, 55100
      • Samsun University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group external oblique intercostal plane block; 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.	Other: EOIP; Ultrasound guided External oblique intercostal block will be performed bilaterally.
Active Comparator: group oblique subcostal transversus abdominis plane block; 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	Other: OSTAP; Ultrasound guided oblique subcostal transversus abdominis plane block will be performed bilaterally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative opioid consumption	tramadol consumption in the first 24 hours after surgery	up to 24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Samsun University
• Investigators: Principal Investigator: gamze MD ertaş, specialist, Samsun University

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2024
• Primary Completion (Actual): November 24, 2024
• Study Completion (Actual): November 25, 2024

Study Registration Dates

• First Submitted: December 7, 2023
• First Submitted That Met QC Criteria: December 7, 2023
• First Posted (Actual): December 15, 2023

Study Record Updates

• Last Update Posted (Estimated): November 27, 2024
• Last Update Submitted That Met QC Criteria: November 25, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: laparoscopic cholecystectomy; oblique subcostal transversus abdominis plane block; external oblique interfascial plane block
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative
• Other Study ID Numbers: trunk block

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No