Perioperative Analgesic Efficiency of Quadratus Lumborum Block vs Epidural in Radical Cystectomy

NCT04133051 | Completed Phase 2

• 1 other identifier: AP1811-30103
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

This study is performed to measure the perioperative analgesic efficiency of bilateral quadratus lumborum block versus epidural analgesia in bladder cancer patients undergoing radical cystectomy

Conditions

Pain, Postoperative

Keywords

quadratus lumborum block; epidural analgesia; bladder cancer; radical cystectomy

Outcome Measures

Primary Outcomes (4)

• Visual analogue pain (VAS) score measurement postoperatively

  The primary outcome measures visual analogue pain scores in the two groups at the end of surgery

  0 Hours Postoperatively

• Visual analogue pain (VAS) score measurement 6 hours postoperatively

  The primary outcome measures visual analogue pain scores in the two groups 6 hours postoperatively

  6 Hours Postoperatively

• Visual analogue pain (VAS) score measurement 24 hours postoperatively

  The primary outcome measures visual analogue pain scores in the two groups 24 hours postoperatively

  24 Hours Postoperatively

• Visual analogue pain (VAS) score measurement 48 hours postoperatively

  The primary outcome measures visual analogue pain scores in the two groups 48 hours postoperatively

  48 Hours Postoperatively

Secondary Outcomes (1)

• Postoperative Nausea and Vomiting

  48 Hours Postoperatively

Other Outcomes (2)

• Morphine Usage

  48 Hours Postoperatively

• Patient's satisfaction

  48 Hours Postoperatively

Study Arms (2)

Quadratus Lumborum Block

ACTIVE COMPARATOR

17 cases will be subjected to bilateral Ultrasound-guided Quadratus lumborum block through bilateral catheter insertion for perioperative analgesia.

Drug: Quadratus Lumborum Block Using Bupivacaine 0.2%

Epidural Analgesia

ACTIVE COMPARATOR

17 cases will be subjected to epidural catheter insertion for perioperative analgesia (as a control group).

Drug: Epidural Analgesia Using Bupivacaine 0.25%

Interventions

Quadratus Lumborum Block Using Bupivacaine 0.2% DRUG

Ultrasound guided transmuscular approach for quadratus lumborum block using an 18 gauge Touhy's epidural needle to insert the catheter. Normal saline 5 mL will be used to identify that plane. A volume of 20 ml of 0.25% of Bupivacaine bolus will be injected in that plane just over QL. This will be followed by epidural catheter insertion to facilitate continuous infusion. A similar procedure will be performed on the other side. A continuous infusion of 0.2% Bupivacaine at 5 ml/h will be administered to the patient. This transmuscular quadratus lumborum (TQL) block, has been suggested to be a simple and perhaps safer alternative to the anterior approach as was described for the original QL block

Also known as: Transmuscular QL

Quadratus Lumborum Block

Epidural Analgesia Using Bupivacaine 0.25% DRUG

With Patients placed in sitting position, puncture site will be identified at (T8-9, T9-10, or T10-11) intervertebral spaces. Using aseptic conditions, an 18G Tuohy epidural needle will be used to insert epidural catheter as appropriate. Induction of epidural analgesia with 10-15 ml bupivacaine 0.25% preoperatively with top up doses of 5-7 ml bupivacaine 0.25% or equivalent administered judiciously till we achieve analgesic level of T4 to L1. The calculated top up doses will be administered each hour using bupivacaine 0.25% or by using a continuous infusion syringe pump for equivalent doses

Also known as: Thoracic Epidural

Epidural Analgesia

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA II-III
• Adult patients (\>18 years old)
• Both sexes
• Scheduled for radical cystectomy at NCI, CU

You may not qualify if:

• Patient's refusal of the study procedures
• Allergy to drugs used in the study
• Patients with chronic pain
• Patients with coagulopathies (INR \> 1.6 or platelets count \< 50,000 cc3)
• Hemodynamically unstable patients (e.g. BP \< 90/60)
• Patients with local or intra-abdominal infections concerning intervention sites and septic patients

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National Cancer Institute - Cairo University

Cairo, 11796, Egypt

Location

Related Publications (2)

• Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015 Nov;32(11):812-8. doi: 10.1097/EJA.0000000000000299.

  PMID: 26225500 BACKGROUND

• Blanco R, Ansari T, Riad W, Shetty N. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):757-762. doi: 10.1097/AAP.0000000000000495.

  PMID: 27755488 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Urinary Bladder Neoplasms

Interventions

Tea

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Ahmed H. Bakeer, M.D.

  National Cancer Institute, Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Group (A): 17 cases will be subjected to bilateral Ultrasound-guided Quadratus lumborum block through bilateral catheter insertion for perioperative analgesia. Group (B): 17 cases will be subjected to epidural catheter insertion for perioperative analgesia (as a control group). This number is to be increased to 34 patients (17 patients in each group) to account for the necessity to use non-parametric test. Sample size was calculated using G\*Power program (University of Düsseldorf, Düsseldorf, Germany) 17, 20, 21.

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: October 21, 2019
• Study Start: November 15, 2018
• Primary Completion: September 15, 2020
• Study Completion: September 15, 2020
• Last Updated: September 25, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)