Comparison of OSTAP and EOIP Blocks in Laparoscopic Cholecystectomies

NCT06172465 | Completed

• 1 other identifier: trunk block
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesia; Pain, Post Operative

Keywords

laparoscopic cholecystectomy; oblique subcostal transversus abdominis plane block; external oblique interfascial plane block

Outcome Measures

Primary Outcomes (1)

• Postoperative opioid consumption

  tramadol consumption in the first 24 hours after surgery

  up to 24 hours

Secondary Outcomes (3)

• NRS scores

  At 1,3, 6, 12, 18, 24 hours

• Quality of recovery

  24 hours

• Nausea and vomiting

  At 1,3, 6, 12, 18, 24 hours

Study Arms (2)

group external oblique intercostal plane block

ACTIVE COMPARATOR

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

group oblique subcostal transversus abdominis plane block

ACTIVE COMPARATOR

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

Interventions

EOIP OTHER

Ultrasound guided External oblique intercostal block will be performed bilaterally.

group external oblique intercostal plane block

OSTAP OTHER

Ultrasound guided oblique subcostal transversus abdominis plane block will be performed bilaterally.

group oblique subcostal transversus abdominis plane block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI \< 35 kg/m² Patients with ASA scores I and II

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsun University: lead

Study Sites (1)

Samsun University

Samsun, Ilkadım, 55100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Study Officials

• gamze MD ertaş, specialist

  Samsun University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The anesthetist who will perform the blocks 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: two interventional group

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 15, 2023
• Study Start: January 5, 2024
• Primary Completion: November 24, 2024
• Study Completion: November 25, 2024
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)