Postoperative Analgesic Effects of Bilateral External Oblique Intercostal Block in Laparoscopic Cholecystectomy Surgery

NCT05444985 | Completed

• 1 other identifier: HATICE55
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of our study is to reduce postoperative pain by performing external oblique intercostal block in L/S cholecystectomy surgeries. Our main goal is to provide well managed post-operative analgesia.

Conditions

Analgesia; Pain, Postoperative

Keywords

External oblique intercostal block; Pain management

Outcome Measures

Primary Outcomes (1)

• Postoperative opioid consumption

  Contramal consumption in the first 24 hours after surgery

  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)

External Oblique Intercostal Block Group

EXPERIMENTAL

While patients are still under general anesthesia, external oblique intercostal block (EOIB) will be performed bilaterally according to appropriate asepsis/antisepsis rules before awakening.

Other: Pain Management

Control

ACTIVE COMPARATOR

Patients in the control group will not have any intervention concerning regional anesthesia.

Other: Pain Management

Interventions

Pain Management OTHER

Regional anesthetic techniques for peri-operative pain management after surgery.

Control; External Oblique Intercostal Block Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• 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, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Interventions

Pain Management

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

Intervention Hierarchy (Ancestors)

Therapeutics; Disease Management; Patient Care Management; Health Services Administration

Study Officials

• Hatice Kusderci, M.D.

  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 block 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: One interventional group and one control group.

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 6, 2022
• Study Start: July 17, 2022
• Primary Completion: May 9, 2023
• Study Completion: May 9, 2023
• Last Updated: July 21, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)