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

NCT06640062 | Completed

• 1 other identifier: 118-2022
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Degree of pain intensity

  The degree of pain intensity was assessed using the Visual Analogue Scale (VAS). Each patient was instructed about postoperative pain assessment with the VAS. VAS(0 represents "no pain" while 10 represents "the worst pain imaginable"). It was assessed at 30 minutes, 2, 4, 6, 8, 12, 16, 20, and 24 hours postoperatively.

  24 hours postoperatively

Secondary Outcomes (5)

• Time to first rescue analgesia

  24 hours postoperatively

• Total amount of morphine consumption

  24 hours postoperatively

• Morphine-related side effects

  24 hours postoperatively

• Local anesthetics-related side effects

  24 hours postoperatively

• Incidence of adverse effects of the block technique

  24 hours postoperatively

Study Arms (2)

Erector spinae plane block group

ACTIVE COMPARATOR

Patients received ultrasound-guided erector spinae plane block.

Other: Erector spinae plane block

Oblique subcostal transversus abdominis plane block group

EXPERIMENTAL

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

Other: Oblique subcostal transversus abdominis plane block

Interventions

Erector spinae plane block OTHER

Patients received ultrasound-guided erector spinae plane block.

Erector spinae plane block group

Oblique subcostal transversus abdominis plane block OTHER

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

Oblique subcostal transversus abdominis plane block group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Helwan University: lead

Study Sites (1)

Helwan University

Helwan, Cairo Governorate, 11795, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Helwan University, Egypt.

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 15, 2024
• Study Start: January 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)