Clinical trial NCT06172465: Comparison of OSTAP and EOIP Blocks in Laparoscopic Cholecystectomies
Official title: Comparison of Bilateral Oblique Transversus Abdominis Plane Block (OSTAPB) and Bilateral External Oblique Intercostal Plane Block (EOIPB) in Laparoscopic Cholecystectomies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Pain, Post Operative
Keywords: laparoscopic cholecystectomy
oblique subcostal transversus abdominis plane block
external oblique interfascial plane block
Lead sponsor: Samsun University
Sponsor class: OTHER
First posted: 2023-12-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two interventional group
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Postoperative opioid consumption
timeFrame: up to 24 hours
Secondary outcomes:
measure: NRS scores
timeFrame: At 1,3, 6, 12, 18, 24 hours
measure: Quality of recovery
timeFrame: 24 hours
measure: Nausea and vomiting
timeFrame: At 1,3, 6, 12, 18, 24 hours
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Samsun University
state: Ilkadım
Study officials:
affiliation: Samsun University
name: gamze MD ertaş, specialist
role: PRINCIPAL_INVESTIGATOR
References: