Quadratus Lumborum Block vs Transversus Abdominis Plane Block in Bladder Cancer Surgeries

NCT04402411 | Unknown

• 1 other identifier: 201617049.3
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

Transversus abdominis plane (TAP) block can be used to provide effective analgesia during the postoperative period following a range of surgeries. TAP block administers local anesthetics between the T6 to L1 spinal nerve roots to stop the nerve signal and to alleviate pain for abdominal procedures 4, 5. The viscera are innervated by the vagal nerve (parasympathetic innervation) and by the splanchnic nerves (sympathetic innervation). The splanchnic nerves carry both visceral efferent and afferent nerve fibers. The sensory (or afferent) part of the splanchnic nerves reach the spinal column at certain spinal segments, It is possible to block central visceral pain conduction with thoracic paravertebral blockade or maybe even with the novel quadratus lumborum (QL) block. The effect of the QL block is believed to result from a spread of LA from its lumbar deposition cranially into the thoracic paravertebral space (TPVS), since Carney et al found traces of contrast agent in the TPVS following application of this block. Hence, the QL block would seem to be able to alleviate both somatic and visceral pain.10 The aim of this study is to compare between quadratus lumborum block, transversus abdominis plane block regarding perioperative analgesia after bladder cancer surgeries by measuring intraoperative hemodynamics, postoperative pain scores and morphine consumption in the first 24 h postoperative.

Conditions

Quadratus Lumborum Block; Transversus Abdominis Plane Block; Bladder Cancer; Postoperative Pain; Surgery

Outcome Measures

Primary Outcomes (1)

• Time to first rescue dose of morphine

  First time at which morphine was given postoperatively (If Vsual analogue scale (VAS) was \>4, 3 mg morphine IV was administered as a rescue analgesia for the first 24 hours)

  24 hours

Secondary Outcomes (2)

• Total dose of postoperative morphine consumption

  24 hours

• Pain intensity by visual analogue scale (VAS)

  24 hours

Study Arms (3)

Control Group

ACTIVE COMPARATOR

Patients will receive general anesthesia with intravenous opioid

Drug: Intravenous opioid

Quadratus lumborum

EXPERIMENTAL

Patients will receive bilateral quadratus lumborum block

Procedure: Quadratus lumborum block

Transversus abdominis plane

EXPERIMENTAL

Patients will receive bilateral transversus abdominis plane block

Procedure: Transversus abdominis plane block

Interventions

Quadratus lumborum block PROCEDURE

The patient will be placed in a lateral position with the side to be blocked facing upwards. The ultrasound probe will be properly sterilized and with sterile covers. An 18-20 gauge blunt tipped block needle or a Tuohy needle is advanced under ultrasound guidance on the posterior aspect of the Quadratus Lumborum. The QL muscle is identified with its attachment to the lateral edge of the transverse process of the L4 vertebral body. With the psoas major muscle anteriorly, the erector spinae muscle posteriorly and the QL muscle adherent to the apex of the transverse process, a well recognisable pattern of a shamrock with three leaves can be seen.

Also known as: Group B

Quadratus lumborum

Transversus abdominis plane block PROCEDURE

The patient will be supine while performing the block and sterilization of the site of the ultrasound and needle entry will be performed. The ultrasound probe is placed in a transverse plane to the lateral abdominal wall in the midaxillary line, between the lower costal margin and iliac crest. The needle is introduced in plane of the ultrasound probe directly under the probe and advanced until it reaches the plane between the internal oblique and transversus abdominis muscles.

Also known as: Group C

Transversus abdominis plane

Intravenous opioid DRUG

Patients will receive morphine 0.1 mg/kg

Also known as: Group A

Control Group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of the patients between 20 to 80 years.
• ASA physical status II -III
• Elective bladder cancer operations.

You may not qualify if:

• Patient refusal
• Local infection at the site of injection
• Allergy to study medications
• Sepsis
• Anatomic abnormalities
• Systemic anticoagulation or coagulopathy
• Inability to comprehend or participate in pain scoring system

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National Cancer Institute - Egypt

Cairo, 11796, Egypt

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Pain, Postoperative

Condition Hierarchy (Ancestors)

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; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Ahmed M Mohammed, MSc

  Assistant lecturer of Anesthesia, ICU, and Pain Relief

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed M Mohammed, MSc

CONTACT

+20 122 431 8828; mans.cerano@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2020
• First Posted: May 26, 2020
• Study Start: June 1, 2020
• Primary Completion: September 30, 2020
• Study Completion: October 5, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)