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

Quadratus Lumborum Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05089994
• Other study ID #: 01060264751
• Status: Recruiting
• Phase: N/A
• Start date: October 6, 2021
• Est. completion date: June 25, 2024

Study information

• Verified date: May 2024
• Source: Assiut University
• Contact: Hassan Mostafa abdelbaky ahmed, Master
• Phone: 01060264751
• Email: hassan.mostafa9444[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 section , laparoscopic gynecologic surgery and hip hemiarthroplasty [6]. At the moment, several approaches for QLB have been reported; lateral (QLB type 1) , posterior (QLB type 2], transmuscular (anterior) [paramedian sagittal oblique [8], supra-iliac anterior [9], and intramuscular approaches . The intramuscular QLB (QLBi) technique was first reported by in 2016. This approach is different from others 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 in which local anesthetics are injected. Therefore, QLBi is relatively easier to perform compared with other QLB approaches. As there are only a few reports on QLBi in the clinical setting , its effectiveness remains controversial. Bladder cancer is an important worldwide health problem with a global estimate of 386,300 new cases and 150,200 deaths in the year 2008. The majority of bladder cancer occurs in males and there is a 14-fold variation in incidence internationally. The highest incidence rates are found in the countries of Europe, North America, and Northern Africa. Smoking and occupational exposure are the major risk factors in Western countries, while chronic infection with Schistosoma Hematobium (SH) in developing countries, particularly in Africa and the Middle East, accounts for the main total burden. The incidence of urinary bladder cancer in the Middle East and Africa is greater in areas with high rather than low SH prevalence. The overall prevalence of SH infection in Egypt was 37-48% that decreased due to the antibilharzial campaign to 3%. The urinary bladder cancer previously accounted for about 31% of the total incidence of cancers in Egypt that subsequently decreased to 12 %. Radical cystectomy has traditionally been considered the standard of therapy for high-grade invasive bladder cancer, with the best survival results and lowest local recurrence rates reported to date . Radical cystectomy provides the optimum result for accurate pathological staging, prevention of local recurrence and overall survival ]. In addition, radical cystectomy may influence the decision for adjuvant chemotherapy based upon clear pathological criteria

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 25, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Quadratus Lumborum Block

Intervention

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.

Locations

Country	Name	City	State
Egypt	Assuit university urology hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the first call for rescue analgesia	The time of the first call of analgesia is recorded	24hours after recovery From anesthesia
Secondary	Total doses of morphine required	Doses of morphine required postoperative	24hours after recovery from anesthesia