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Clinical Trials/NCT03547011
NCT03547011CompletedNot Applicable

The Efficacy of Ultrasound Guided Continuous Quadratus Lumborum Block Versus Continuous Paravertebral Block In Radical Cystectomy

University of Alexandria1 site in 1 country60 target enrollmentStarted: September 16, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
analgesic effect

Study Overview

Brief Summary

The aim of the study to compare between intraoperative and postoperative analgesic effect of ultrasound guided continuous quadratus lumborum block and continuous thoracic paravertebral block in patients operated for radical cystectomy (primary outcome). Side effects, length of hospital stay and patient satisfaction(secondary outcome).

Detailed Description

The analgesic efficacy of ultrasound guided continuous quadratus lumborum block versus continuous paravertebral block in radical cystectomy

Protocol of a thesis submitted to the Faculty of Medicine University of Alexandria In partial fulfillment of the requirements of the degree of Master of Anaesthesia And Surgical Intensive Care

By

Amr Ragheb Hieba MBBCh, Alex. Resident Alexandria University Hospitals Department of Anaesthesia and Surgical Intensive Care Faculty of Medicine University of Alexandria 2017

SUPERVISORS

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Masking Description

The patients, outcome assessors and care providers are not informed with the block type done.

Eligibility Criteria

Ages
18 Years to 99 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •• After written informed consent from each patient or oral consent if illiteracy prevent a written consent, The present study will be carried out in the Urosurgery department at Alexandria Main University hospital on 60 adult patients scheduled for radical cystectomy, males and females.
  • •Patients will be randomly assigned into two equal groups (30 patients each) according to type of the block:
  • •Patients will receive ultrasound guided quadratus lumborum block with 0.3 ml /kg bupivacaine 0.25% on each side with catheter insertion for maintenance doses 0.1ml/kg/hr on each side.
  • •Patients will receive ultrasound guided thoracic paravertebral block with 0.3 ml/kg bupivacaine 0.25 % on each side with catheter insertion for maintenance doses 0.1 ml/kg/hr on each side.

Exclusion Criteria

  • •Patient refusal.
  • •Coagulopathy/ thrombocytopenia.
  • •Localized infection at the proposed site of injection.
  • •Inability to comprehend the scoring systems to be employed due to mental problems.
  • •known allergy to the drugs to be used (local anesthetics, opioids)
  • •Opioid tolerance/ dependence
  • •Back abnormalities.
  • •Neurological deficits.

Arms & Interventions

US guided Quadratus Lumborum block

Active Comparator

Patients will receive ultrasound guided quadratus lumborum block with 0.3 ml /kg bupivacaine 0.25% on each side with catheter insertion for maintenance doses 0.1ml/kg/hr on each side.

Intervention: US guided Quadratus Lumborum block (Procedure)

US guided Paravertebral block.

Active Comparator

Patients will receive ultrasound guided thoracic paravertebral block with 0.3 ml/kg bupivacaine 0.25 % on each side with catheter insertion for maintenance doses 0.1 ml/kg/hr on each side.

Intervention: US guided Paravertebral block. (Procedure)

Outcomes

Primary Outcomes

analgesic effect

Time Frame: 72 hours

Visual Analogue Scale measure and needed postoperative analgesics.0 to 10, as 0 no pain 10 the worst pain.

Secondary Outcomes

  • length of hospital stay(30 days)
  • Side effects(30 days)
  • Patient satisfaction.(30 days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mohammad Hazem I. Ahmad Sabry

Lecturer of Anesthesia

University of Alexandria

Study Sites (1)

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