Dexmedetomidine Versus Fentanyl as Adjuvants to Bupivacaine in Ultrasound Guided Transversus Abdominis Plane Block

March 20, 2020 updated by: Dina Mahmoud Fakhry, Beni-Suef University

A Comparative Study of Dexmedetomidine Versus Fentanyl as Adjuvants to Bupivacaine in Ultrasound Guided Transversus Abdominis Plane Block in Patients Undergoing Radical Cystectomy

The aim and objective of this study is to compare dexmedetomidine and fentanyl as adjuvants to bupivacaine in ultrasound guided TAP block analgesia in patients undergoing radical cystectomy as regarding postoperative analgesic efficacy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Radical cystectomy with pelvic lymph node dissection is the gold standard treatment for muscle invasive bladder cancer and is associated with a high risk of complications. Management of the postoperative pain is important to decrease the length of stay in the hospital and the risk of morbidity. Multimodal analgesia management is utilized for pain observed in the postoperative period.As part of a multimodal analgesic regimen, a peripheral nerve block can decrease opioid consumption, providing more effective analgesia with fewer adverse effects.TAP block is a relatively new regional anesthesia technique that provides analgesia to the parietal peritoneum, as well as skin and muscles of the lower anterior abdominal wall. Dexmedetomidine and fentanyl have been used as adjuvants to local anesthetics in different surgeries to provide superior analgesia and to improve the duration of the block.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Both sexes.
  • ASA grade I and II.
  • Age between 50-70 years.
  • Elective open radical cystectomy.

Exclusion Criteria:

  • Any history or signs of cardiac, hepatic and renal failure.
  • Patients with coagulopathy or under anticoagulation therapy.
  • Infection near the site of needle insertion.
  • Morbid obesity (BMI>40 kg/m2).
  • History of allergic reactions to any of the study medications.
  • Previous abdominal surgery.
  • Patients with any neurological or neuromuscular disorder or history of seizures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group(B)
Patients will receive single shot US guided TAP block using 20 ml bupivacaine 0.25% on each side.
Drug: Bupivacaine
single shot US guided TAP block using 20 ml bupivacaine 0.25%.
Other Names:
  • Sunnypivacaine
Active Comparator: Group(BD)
Patients will receive single shot US guided TAP block using 20 ml bupivacaine 0.25% + 50 µg dexmedetomedine on each side.
Drug: Dexmedetomidine
Single shot US guided TAP block using 20 ml bupivacaine 0.25% + 50 µg dexmedetomedine on each side.
Other Names:
  • Precedex
Active Comparator: Group(BF)
Patients will receive single shot US guided TAP block using 20 ml bupivacaine 0.25% + 50 µg fentanyl on each side.
Drug: Fentanyl
Single shot US guided TAP block using 20 ml bupivacaine 0.25% + 50 µg fentanyl on each side.
Other Names:
  • Fentanyl hameln

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The time for first rescue analgesia after the TAP block.
Time Frame: first 24 hours after block.
Postoperative analgesia duration.
first 24 hours after block.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the total dose of rescue analgesia after TAP bock.
Time Frame: first 24 hours after block.
Postoperative analgesia consumption.
first 24 hours after block.
VAS for pain.
Time Frame: 0, 2, 4, 6, 12 and 24 hours postoperatively.
Postoperative pain at rest and movement.
0, 2, 4, 6, 12 and 24 hours postoperatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beni-Suef University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2020

Primary Completion (Anticipated)

April 1, 2021

Study Completion (Anticipated)

May 1, 2021

Study Registration Dates

First Submitted

March 19, 2020

First Submitted That Met QC Criteria

March 20, 2020

First Posted (Actual)

March 23, 2020

Study Record Updates

Last Update Posted (Actual)

March 23, 2020

Last Update Submitted That Met QC Criteria

March 20, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMBSUREC/08032020/Fakhry

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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