Comparison of OSTAP and EOIP Blocks in Laparoscopic Cholecystectomies

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06172465
• Other study ID #: trunk block
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2024
• Est. completion date: August 1, 2024

Study information

• Verified date: January 2024
• Source: Samsun University
• Contact: gamze MD ertas, specialist
• Phone: 5056587914
• Email: gamzeertas555[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Pain, Post Operative
• Pain, Postoperative

Intervention

Other:
• EOIP
Ultrasound guided External oblique intercostal block will be performed bilaterally.
• OSTAP
Ultrasound guided oblique subcostal transversus abdominis plane block will be performed bilaterally.

Locations

Country	Name	City	State
Turkey	Samsun University	Samsun	Ilkadim

Sponsors (1)

Lead Sponsor	Collaborator
Samsun University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative opioid consumption	tramadol consumption in the first 24 hours after surgery	up to 24 hours
Secondary	NRS scores	NRS scores in the first 24 hours after surgery	At 1,3, 6, 12, 18, 24 hours
Secondary	Quality of recovery	QR15 scores	24 hours
Secondary	Nausea and vomiting	Nausea and vomiting scores in the first 24 hours	At 1,3, 6, 12, 18, 24 hours