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Ketamine Versus Dexmedetomidine With Local Anesthetic in TAP Block

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03060070
Recruitment Status : Completed
First Posted : February 23, 2017
Last Update Posted : July 5, 2017
Sponsor:
Collaborator:
South Egypt Cancer Institute
Information provided by (Responsible Party):
Ahmed H Othman, Assiut University

Tracking Information
First Submitted Date  ICMJE February 17, 2017
First Posted Date  ICMJE February 23, 2017
Last Update Posted Date July 5, 2017
Actual Study Start Date  ICMJE March 10, 2017
Actual Primary Completion Date June 25, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2017)
postoperative rescue morphine consumption [ Time Frame: 24 hours postoperative ]
postoperative rescue morphine consumption
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine Versus Dexmedetomidine With Local Anesthetic in TAP Block
Official Title  ICMJE Comparison of the Analgesic Effect of Ketamine Versus Dexmedetomidine Added to Local Anesthetic in TAP Block for Lower Abdominal Cancer Surgery
Brief Summary Comparing the analgesic effects of ketamine and dexmedetomidine when added to local anesthetic in TAP block for postoperative analgesia after lower abdominal cancer surgery.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Postoperative Analgesia
  • Lower Abdominal Cancer
Intervention  ICMJE
  • 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
  • Drug: control group
    20ml of 0.25% bupivacaine will be injected in each side of the TAP block
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: Ketamine
    • Drug: dexmedetomidine
  • 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
    Interventions:
    • Drug: dexmedetomidine
    • Drug: control group
  • 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
    Interventions:
    • Drug: Ketamine
    • Drug: control group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 20, 2017)
90
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 1, 2017
Actual Primary Completion Date June 25, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03060070
Other Study ID Numbers  ICMJE 321
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ahmed H Othman, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE South Egypt Cancer Institute
Investigators  ICMJE Not Provided
PRS Account Assiut University
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP