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Efficacy of Preventive Ketamine on Postoperative Pain

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ClinicalTrials.gov Identifier: NCT04908579
Recruitment Status : Recruiting
First Posted : June 1, 2021
Last Update Posted : June 28, 2022
Sponsor:
Information provided by (Responsible Party):
Dr.Ibrahim Mamdouh Esmat, Ain Shams University

Tracking Information
First Submitted Date  ICMJE May 27, 2021
First Posted Date  ICMJE June 1, 2021
Last Update Posted Date June 28, 2022
Actual Study Start Date  ICMJE June 15, 2021
Estimated Primary Completion Date September 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2021)
Time to first given rescue analgesia(minutes) [ Time Frame: 24 hours postoperatively ]
Time to first given rescue analgesia(minutes)
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 Efficacy of Preventive Ketamine on Postoperative Pain
Official Title  ICMJE Efficacy of Preventive Ketamine on Postoperative Pain: A Randomized, Double-blind Trial of Patients Undergoing Laparoscopic Sleeve Gastrectomy
Brief Summary
  • Although bariatric surgery is mainly performed laparoscopically, analgesic optimization is still essential to reduce complications and to improve the patients' comfort. In laparoscopic sleeve gastrectomy, the intraoperative peritoneal instillation of bupivacaine hydrochloride (30 ml, 0.25%) was known to be safe and effective in reducing postoperative pain, nausea, and vomiting.
  • Furthermore, usage of ketamine both as a pre and post-operative pain management is well established. Ketamine can be used solely or in combination with other co-adjuvant drugs, increasing their efficacy. Many therapeutic properties of ketamine have been attributed to its antagonism mechanism to N-Methyl-D-aspartate receptors.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Condition  ICMJE Postoperative Pain
Intervention  ICMJE
  • Drug: bupivacaine(intraperitoneally) and ketamine (intraperitoneally)
    1. 40 ml volume of bupivacaine 0.25% + ketamine 0.5 mg/kg distributed as 30 ml intraperitoneally and 10 ml as port site infiltration
    2. 10 ml normal saline 0.9% will be given intravenous.
  • Drug: bupivacaine(intraperitoneally) and ketamine (intravenously)
    1. 40 ml volume of bupivacaine 0.25% only distributed as 30 ml intraperitoneally and 10 ml as port site infiltration
    2. 10 ml volume of ketamine 0.5 mg/kg intravenously will be given after delivering the gastric sleeve and before start closure of port sites.
  • Drug: bupivacaine(intraperitoneally)
    1. 40 ml volume of bupivacaine 0.25% only distributed as 30 ml intraperitoneally and 10 ml as port site infiltration
    2. 10 ml normal saline 0.9% will be given intravenous.
Study Arms  ICMJE
  • Active Comparator: - GROUP (I): 30 patients
    Intervention: Drug: bupivacaine(intraperitoneally) and ketamine (intraperitoneally)
  • Active Comparator: - GROUP (II): 30 patients
    Intervention: Drug: bupivacaine(intraperitoneally) and ketamine (intravenously)
  • Active Comparator: - GROUP (III) (Control): 30 patients
    Intervention: Drug: bupivacaine(intraperitoneally)
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 27, 2021)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2022
Estimated Primary Completion Date September 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • - Body mass index > 35 and < 60 kg/m2
  • Either medically free or with well controlled hypertension and/or diabetes.

Exclusion Criteria:

  • - Patient's refusal to participate in the study
  • BMI > 60 kg/m2.
  • Age less than 21 years.
  • Patients with severe systemic disease which is not life-threatening.
  • Patients on antipsychotics, antidepressants and/or corticosteroids.
  • Patients with history of obstructive sleep apnea.
  • Allergic reaction to any of the study medications.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ibrahim Mamdouh Esmat 01001241928 ibrahim_mamdouh@med.asu.edu.eg
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04908579
Other Study ID Numbers  ICMJE FMASU MD 87/ 2021
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Dr.Ibrahim Mamdouh Esmat, Ain Shams University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Ain Shams University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ain Shams University
Verification Date June 2022

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