Ultrasound-Guided Erector Spinae Plane Block Versus Oblique Subcostal Transversus Abdominis Plane Block in Laparoscopic Cholecystectomy

NCT ID: NCT06640062

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2024-09-01

Brief Summary

The aim of this work was to compare the effect of using oblique subcostal transversus abdominis plane (OSTAP) block and erector spinae plane (ESP) block as a part of multi-modal analgesia technique in patients undergoing laparoscopic cholecystectomy.

Detailed Description

Laparoscopic cholecystectomy is a commonly performed surgery and requires multi-modal analgesia for better control of pain. Untreated post-operative pain has many consequences, including patient dissatisfaction, transition into chronic pain, delayed discharge from the hospital, and increased healthcare costs.

Many inter-fascial plane blocks like oblique subcostal transversus abdominis plane (OSTAP) block and recently, erector spinae plane (ESP) block have been utilized as a part of multi modal analgesia technique in many abdominal surgeries.

Conditions

Ultrasound; Erector Spinae Plane Block; Oblique Subcostal Transversus Abdominis Plane Block; Laparoscopic Cholecystectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Erector spinae plane block group

Patients received ultrasound-guided erector spinae plane block.

Group Type: ACTIVE_COMPARATOR

Erector spinae plane block

Intervention Type: OTHER

Patients received ultrasound-guided erector spinae plane block.

Oblique subcostal transversus abdominis plane block group

Patients received ultrasound-guided oblique subcostal transversus abdominis plane block.

Group Type: EXPERIMENTAL

Oblique subcostal transversus abdominis plane block

Intervention Type: OTHER

Patients received ultrasound-guided oblique subcostal transversus abdominis plane block.

Interventions

Erector spinae plane block

Patients received ultrasound-guided erector spinae plane block.

Intervention Type: OTHER

Oblique subcostal transversus abdominis plane block

Patients received ultrasound-guided oblique subcostal transversus abdominis plane block.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age from 20 to 60 years.
• Both gender.
• American Society of Anesthesiologists (ASA) grade I and II physical status.
• Body mass index (BMI): ≥ 20 kg/m2 and ≤ 35 kg/m2.
• Underwent laparoscopic cholecystectomy.

Exclusion Criteria

• Patient refusal.
• Known sensitivity or contraindication to drugs used in the study (local anesthetics, opioids).
• History of psychological disorders and/or chronic pain syndrome.
• Contraindication to regional anesthesia, e.g., local sepsis, pre-existing peripheral neuropathies, and coagulopathy.
• Severe respiratory disorders such as (severe obstructive pulmonary disease, forced expiratory volume (FEV1), forced vital capacity (FVC) <50% or severe restrictive pulmonary disease, and adult respiratory distress syndrome).
• Severe cardiac disorders such as (heart failure).
• Advanced liver disease (elevated liver enzymes more than 3 folds of normal range).
• Advanced kidney disease (Decreased creatinine clearance <40 ml/min).
• Pregnancy.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helwan University

OTHER

Sponsor Role: lead

Responsible Party

Michael Fayez Yousef Metias

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Helwan University, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Helwan University

Helwan, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

118-2022

Identifier Type: -

Identifier Source: org_study_id