Comparison of Two Approaches of Quadratus Lumborum Block for Post-operative Analgesia in Radical Cystectomy

Comparison of Two Approaches of Quadratus Lumborum Block for Post-operative Analgesia in Radical Cystectomy: Prospective-randomized Clinical Trial

To compare the postoperative analgesic effect of two ultrasound guided approaches of quadratus lumborum block (QLB) (anterior and intramuscular) for radical cystectomy.

Study Overview

• Status: Recruiting
• Conditions: Quadratus Lumborum Block
• Intervention / Treatment: Procedure: US guided injection

Detailed Description

The quadratus lumborum block (QLB) is one of the abdominal wall block techniques used to anesthetize thoracolumbar nerves . The QLB technique was described initially by Blanco et al. in 2007 (not published), then reported initially by Kadam in 2013. Since then, QLB has evolved with the development of the ultrasound-guided nerve block. To date, several randomized controlled trials have reported effective postoperative analgesia, with non-intramuscular QLB for cesarean sections, laparoscopic gynecologic surgery and hip hemiarthroplasty .

The intramuscular QLB (QLBi) technique was first reported by. This approach is different from others in tubouchi for QLB; although the injection target sites of the other approaches are planes around the quadratus lumborum muscle, the intramuscular approach penetrates the fascia of the quadratus lumborum muscle, where local anesthetics are injected. Therefore, QLBi is relatively easier to perform compared with other QLB approaches.

The incidence of urinary bladder cancer in the Middle East and Africa is greater in areas with high rather than low SH prevalence.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hassan Mostafa abdelbaky ahmed, Master; Phone Number: 01060264751; Email: hassan.mostafa9444@gmail.com
• Study Contact Backup: Name: Abdel raheem Mahmoud Mohamed, Prof; Phone Number: 01000032655

Study Locations

• Egypt
  • Assiut, Egypt
    • Recruiting
    • Assuit university urology hospital
    • Contact: Hassan Mostafa abdelbaky; Phone Number: 01060264751; Email: Hassan.mostafa9444@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age: 40-70years.

  • BMI: 20-30 kg.m2
  • Sex: both males and females.
  • American Society of Anesthesiologists (ASA )physical status: I-III.
  • Operation: radical cystectomy

Exclusion Criteria:

• • Patient's refusal to participate in the study.

  • known allergy to local anesthesia (LA),
  • coagulopathy or thrombocytopenia,
  • body mass index (BMI) above 30 kg .m 2, and infection at site of injection.
  • Chronic pain syndromes,
  • Prolonged opioid medication,
  • Patients on regular use of analgesic or who received analgesic 24 h before surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 (QLBA) will include 30 patients; will receive ultrasound-guided anterior approach quadratus lumborum block	Procedure: US guided injection; using 2.5mg/kg of 0.25% bupivacaine diluted in a 20 mL syringe of normal saline , received ultrasound-guided quadratus lumborum.
Experimental: Group 2 (QLBI)will include 30 patients.; received ultrasound-guided intramuscular quadratus lumborum.	Procedure: US guided injection; using 2.5mg/kg of 0.25% bupivacaine diluted in a 20 mL syringe of normal saline , received ultrasound-guided quadratus lumborum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the first call for rescue analgesia	The time of the first call of analgesia is recorded	24hours after recovery From anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total doses of morphine required	Doses of morphine required postoperative	24hours after recovery from anesthesia

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2021
• Primary Completion (Estimated): September 4, 2024
• Study Completion (Estimated): September 25, 2024

Study Registration Dates

• First Submitted: May 22, 2021
• First Submitted That Met QC Criteria: October 10, 2021
• First Posted (Actual): October 22, 2021

Study Record Updates

• Last Update Posted (Actual): July 31, 2024
• Last Update Submitted That Met QC Criteria: July 30, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 01060264751

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No