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Clinical Trials/NCT05278598
NCT05278598
Completed
Not Applicable

Comparative Assessment of 3 Ultrasound Guided Plane Blocks for Perioperative Analgesia in Patients Undergoing Radical Cystectomy: A Randomized Clinical Trial

Nazmy Edward Seif1 site in 1 country120 target enrollmentMarch 27, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer, Bladder
Sponsor
Nazmy Edward Seif
Enrollment
120
Locations
1
Primary Endpoint
Morphine consumption.
Status
Completed
Last Updated
last year

Overview

Brief Summary

Radical cystectomy is the gold standard treatment for muscle invasive bladder cancer as well as some T1 and non-invasive disease. It is a major operation with significant perioperative morbidity and complications. Pain is one of the most important complications to be managed.

Regional blocks as a part of multi-modal analgesia are considered main strategies of Enhanced Recovery after Surgery (ERAS) decreasing post-operative complications including post-operative pain and post-operative hospital stay. They also have an upper hand over systemic intravenous opioids decreasing the risk for post-operative delirium specially in old age patients. Thoracic paravertebral plane block (TPVPB), intra muscular quadratus lumborum plane block (QLPB) and erector spinae plane block (ESPB) are among these regional anesthesia techniques for pain management.

Erector spinae plane block is an emerging block, with low risk and more feasibility, but efficacy hasn't been compared to quadratus lumborum and paravertebral plane blocks altogether in radical cystectomy surgeries.

All these blocks are effective in reducing postoperative pain and the need of analgesia in radical cystectomy surgery; this is a comparative study between the three blocks in this population.

Registry
clinicaltrials.gov
Start Date
March 27, 2022
End Date
August 16, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Nazmy Edward Seif
Responsible Party
Sponsor Investigator
Principal Investigator

Nazmy Edward Seif

Clinical Professor

Cairo University

Eligibility Criteria

Inclusion Criteria

  • American Society of Anesthesiologists (ASA) class II - III.
  • Adult patients scheduled for radical cystectomy.

Exclusion Criteria

  • Patient refusal.
  • Uncooperative patients.
  • Patients with known allergies to local anesthetics.
  • Bleeding disorders or coagulopathy.
  • Anatomical abnormality or infection at injection site.
  • Patients receiving opioids for chronic analgesic therapy.
  • Spinal anesthesia or any other regional anesthesia.

Outcomes

Primary Outcomes

Morphine consumption.

Time Frame: 24 hours

Total dose of Morphine (measured in mg) given intra-venously to the patient post-operatively.

Study Sites (1)

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