Ultrasound Guided Erector Spinae Plane Block Versus Quadratus Lumborum Block in Laparoscopic Cholecystectomy

NCT04845711 | Unknown

• 1 other identifier: 34503/2/21
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to compare between the efficacy of ultrasound guided erector spinae plane block and ultrasound guided quadratus lumborum block in managing acute postoperative pain in patients undergoing laparoscopic cholecystectomy.

Conditions

Laparoscopic Cholecystectomy; Postoperative Analgesia; Erector Spinae Plane Block; Quadratus Lumborum Block

Outcome Measures

Primary Outcomes (1)

• The degree of postoperative pain in the first 24 hours post-operative

  Postoperative pain will be assessed by the numerical rating scale (NRS); 0 no pain while 10 is the maximum pain) after discharge to the ward ,and at 6, 12, 18, 24 hours.

  first 24 hours post-operative

Secondary Outcomes (3)

• Time to first analgesic requirement

  first 24 hours post-operative

• Total dose of intraoperative consumption of fentanyl

  intraoperative

• Total dose of rescue analgesia in the first 24hr postoperative

  first 24 hours post-operative

Study Arms (3)

Control group

PLACEBO COMPARATOR

patients will receive general anesthesia only.

Other: Control group

Erector spinae plane block group

EXPERIMENTAL

patients will receive general anesthesia and bilateral ultrasound guided erector spinae plane block (20ml Bupivacaine 0.25%)

Procedure: Erector spinae plane block group

Quadratus lumborum block group

EXPERIMENTAL

patients will receive general anesthesia and bilateral ultrasound guided quadratus lumborum block (20 ml Bupivacaine 0.25%)

Procedure: Quadratus lumborum block group

Interventions

Control group OTHER

patients will receive general anesthesia only.

Also known as: Group C

Control group

Erector spinae plane block group PROCEDURE

patients will receive general anesthesia and bilateral ultrasound guided erector spinae plane block (20ml Bupivacaine 0.25%)

Also known as: group ESPB

Erector spinae plane block group

Quadratus lumborum block group PROCEDURE

patients will receive general anesthesia and bilateral ultrasound guided quadratus lumborum block (20 ml Bupivacaine 0.25%)

Also known as: group QLB

Quadratus lumborum block group

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 21-65 years
• both genders
• American Society of Anesthesiology (ASA) class I-II
• Undergoing elective laparoscopic cholecystectomy

You may not qualify if:

• Patient refusal.
• Coagulopathy.
• History of allergy to local anaesthetic.
• History of liver or renal pathology affecting drug elimination
• Mental dysfunction or cognitive disorders.
• Use of medication such as gabapentin-pregabalin that could affect pain perception.
• Body Mass Index \> 40 kg/m2.

Sponsors & Collaborators

• Tanta University: lead

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Mai E Hamada, MBBCH

  Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mai E Hamada, MBBCH

CONTACT

00201285851295; mai154450_pg@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients and medical personnel collecting data and conducting follow-up will be blinded to the group of the patient. All blocks will be performed by one anesthesiologist who will not participate in data collection or analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine

Study Record Dates

• First Submitted: April 11, 2021
• First Posted: April 15, 2021
• Study Start: May 1, 2021
• Primary Completion: October 31, 2021
• Study Completion: November 1, 2021
• Last Updated: April 15, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 6 months after the end of study For 2 years
• Access Criteria: Data are available upon reasonable request from the principal investigator