Clinical trial

Comparison of External Oblique Intercostal Plane Block Oblique Subcostal Transversus Abdominis Plane Block and Local Anesthetic Infiltration Methods in Laparoscopic Cholecystectomies

Name

ACHBILKENT-ANEST-BK-01

Description

This study is to demonstrate the effectiveness of external oblique intercostal plane block, a new block method, in the treatment of postoperative pain occurring after laparoscopic cholecystectomy operations, which are frequently and widely performed today. It aims to add new applications to multimodal analgesia methods, which provide the greatest contribution to the early recovery process after surgery, and to contribute to the early recovery process by increasing patient satisfaction.

Trial arms

Trial start

2024-03-20

Estimated PCD

2024-09-20

Trial end

2024-10-20

Status

Active (not recruiting)

Treatment

unilateral external oblique intercostal plane block group

USG guided external oblique intercostal plane block will perform unilateral with Bupivacaine 25 patient included and patients were observed for pain for 24 hours

Arms:

External oblique intercostal plane block group

unilateral oblique subcostal transversus abdomınıs plane block group

USG guided oblique subcostal transversus abdomınıs plane block block will perform unilateral with Bupivacaine. 25 patient included and patients were observed for pain for 24 hours

Arms:

Oblique subcostal transversus abdomınıs plane block group

Local anesthetic infiltration group

Bupivacaine infiltration will be performed to trocar insertion sites. 25 patient included and patients were observed for pain for 24 hours

Arms:

Local anesthetic infiltration group

Control group

All patients were followed using a standardized postoperative analgesia protocol which includes tramadol patient controlled analgesia. Tramadol at a concentration of 5 mg/mL is included in our patient controlled analgesia protocol (total volume 100 mL.) patient controlled analgesias were set to no basal infusion and 10 mg bolus doses with a 20 min lock time 25 patient included and patients were observed for pain for 24 hours

Arms:

Control Group

Other names:

intravenous patient controlled analgesia group with tramadol

Size

100

Primary endpoint

Amount of postoperative opioid use

24 hours

Finding out which method is more effective according to the Numerical Rating Scale (0-10)

24 hours

Eligibility criteria

Inclusion Criteria: * age 18-65 * Patients undergoing elective laparoscopic cholecystectomy * American Society of Anesthesiologists score 1-2 patients * Body mass index ) \<35kg/m2 * Patients whose consent was obtained before the procedure Exclusion Criteria: * Patients under the age of 18 and over the age of 65 * American Society of Anesthesiologists score III and above * Surgeries with an operating time exceeding 120 minutes * Emergency surgeries * Those who have had abdominal surgery * Pregnant or breastfeeding patients * Those who have coagulopathy and use anticoagulant drugs * Those who are allergic to local anesthetics * Those with localized infection at the injection site * Patients who do not have the ability to use patient controlled analgesia and evaluate Numerical rating scale * Patients with peripheral nerve disease * Patients with renal failure and congestive heart failure * Patients undergoing elective laparoscopic cholecystectomy due to malignancy * Surgeries where open surgery is performed during the operation

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Evaluation of postoperative pain in 4 groups in laparoscopic cholecystectomy with control group', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Patients were not told which method would be used The person evaluating the patients did not know which method was applied to which patient.', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ACTUAL'}}

Updated at

2024-06-05

1 organization

1 product

2 indications

Organization

Ankara City Hospital Bilkent

Product

Control

Indication

Postoperative Pain

Indication

Regional Anaesthesia