Ketamine Versus Dexmedetomidine With Local Anesthetic in TAP Block

July 1, 2017 updated by: Ahmed H Othman, Assiut University

Comparison of the Analgesic Effect of Ketamine Versus Dexmedetomidine Added to Local Anesthetic in TAP Block for Lower Abdominal Cancer Surgery

Comparing the analgesic effects of ketamine and dexmedetomidine when added to local anesthetic in TAP block for postoperative analgesia after lower abdominal cancer surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Assiut University
      • Assiut, Assiut University, Egypt, 171516
        • South Egypt Cancer Institute

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients ASA I and II to whom abdominal surgery for cancer will be conducted will be included in the study

Exclusion Criteria:

  • Coagulopathies
  • ASA III or IV, patient refusal, sensitivity to the used drugs

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: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: control group,
saline in the same volume will be added to the local anesthetic for TAP block in patients undergoing abdominal cancer surgery
Drug: Ketamine
Ketamine at a dose of 0.5mg/kg will be added to bupivacaine 0.25 (total volume 20ml) in each side using sonar guided TAP block
Drug: dexmedetomidine
dexmedetomidine at a dose of 1ug/kg will be added to bupivacaine 0.25 (total volume 20ml) in each side using sonar guided TAP block
Active Comparator: ketamine group,
ketamine in a dose of 0.5mg/kg will be added to the local anesthetic for TAP block in patients undergoing abdominal cancer surgery
Drug: dexmedetomidine
dexmedetomidine at a dose of 1ug/kg will be added to bupivacaine 0.25 (total volume 20ml) in each side using sonar guided TAP block
Drug: control group
20ml of 0.25% bupivacaine will be injected in each side of the TAP block
Active Comparator: dexmedetomidine group
dexmedetomidine in a dose of 1ug/kg will be added to the local anesthetic for TAP block in patients undergoing abdominal cancer surgery
Drug: Ketamine
Ketamine at a dose of 0.5mg/kg will be added to bupivacaine 0.25 (total volume 20ml) in each side using sonar guided TAP block
Drug: control group
20ml of 0.25% bupivacaine will be injected in each side of the TAP block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative rescue morphine consumption
Time Frame: 24 hours postoperative
postoperative rescue morphine consumption
24 hours postoperative

Collaborators and Investigators

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

Sponsor

Assiut University

Collaborators

South Egypt Cancer Institute

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 (Actual)

March 10, 2017

Primary Completion (Actual)

June 25, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

February 17, 2017

First Submitted That Met QC Criteria

February 20, 2017

First Posted (Actual)

February 23, 2017

Study Record Updates

Last Update Posted (Actual)

July 5, 2017

Last Update Submitted That Met QC Criteria

July 1, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 321

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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