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Surgical Site Infiltration Using Ketamine Versus Bupivacaine for Analgesia in Post-operative Appendectomy Operation

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05097118
Recruitment Status : Recruiting
First Posted : October 27, 2021
Last Update Posted : November 5, 2021
Sponsor:
Information provided by (Responsible Party):
Gehad Ahmed Aly, Sohag University

Tracking Information
First Submitted Date  ICMJE October 17, 2021
First Posted Date  ICMJE October 27, 2021
Last Update Posted Date November 5, 2021
Actual Study Start Date  ICMJE September 1, 2021
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2021)
Comparison study between Ketamine and Bupivacaine for post operative analgesia [ Time Frame: one year ]
Analgesia for post -operative Appendectomy operation
Original Primary Outcome Measures  ICMJE
 (submitted: October 17, 2021)
Analgesia [ Time Frame: one year ]
Analgesia for post -operative Appendectomy operation
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 Surgical Site Infiltration Using Ketamine Versus Bupivacaine for Analgesia in Post-operative Appendectomy Operation
Official Title  ICMJE Surgical Site Infiltration Using Ketamine Versus Bupivacaine for Analgesia in Post-operative Appendectomy Operation
Brief Summary surgical site infiltration using ketamine versus Bupivacaine for analgesia in post-operative Appendectomy operation by Ketamine versus Bupivacaine
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Appendicitis Acute
Intervention  ICMJE Drug: Ketamine Versus Bupivacaine
Drugs Ketamine versus Bupivacaine
Study Arms  ICMJE
  • Experimental: Group of Ketamine injection
    Ketamine infiltration for post operative analgesia
    Intervention: Drug: Ketamine Versus Bupivacaine
  • Experimental: Group of Bupivacaine injection
    Bupivacaine infiltration for post operative analgesia
    Intervention: Drug: Ketamine Versus Bupivacaine
Publications *

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 17, 2021)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2022
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 60 adult patients with ASA physical physical status class 1 and class 2 undergoing uncomplicated appendectomy under general anesthesia

Exclusion Criteria:

  • Patient refusal
  • drug abuse
  • Patient with neurological, psychiatirc or neuromuscular disease
  • chronic pain on medicine
  • known allergy to the study medicine
  • Infection at the site of infiltration
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 50 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Gehad a Ali, resident 01012681202 gehad011073@med.sohag.edu.eg
Contact: Ahmed E Abd Elrahman, professor 01118011611
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05097118
Other Study ID Numbers  ICMJE Soh-Med-21-10-03
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Gehad Ahmed Aly, Sohag University
Study Sponsor  ICMJE Sohag University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sohag University
Verification Date October 2021

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