Efficacy of Preventive Ketamine on Postoperative Pain
Primary Purpose
Postoperative Pain
Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
bupivacaine(intraperitoneally) and ketamine (intraperitoneally)
bupivacaine(intraperitoneally) and ketamine (intravenously)
bupivacaine(intraperitoneally)
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Pain
Eligibility Criteria
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.
Sites / Locations
- Ain-Shams University HospitalsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
- GROUP (I): 30 patients
- GROUP (II): 30 patients
- GROUP (III) (Control): 30 patients
Arm Description
Outcomes
Primary Outcome Measures
Time to first given rescue analgesia(minutes)
Time to first given rescue analgesia(minutes)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04908579
Brief Title
Efficacy of Preventive Ketamine on Postoperative Pain
Official Title
Efficacy of Preventive Ketamine on Postoperative Pain: A Randomized, Double-blind Trial of Patients Undergoing Laparoscopic Sleeve Gastrectomy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2021 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
- GROUP (I): 30 patients
Arm Type
Active Comparator
Arm Title
- GROUP (II): 30 patients
Arm Type
Active Comparator
Arm Title
- GROUP (III) (Control): 30 patients
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
bupivacaine(intraperitoneally) and ketamine (intraperitoneally)
Intervention Description
40 ml volume of bupivacaine 0.25% + ketamine 0.5 mg/kg distributed as 30 ml intraperitoneally and 10 ml as port site infiltration
10 ml normal saline 0.9% will be given intravenous.
Intervention Type
Drug
Intervention Name(s)
bupivacaine(intraperitoneally) and ketamine (intravenously)
Intervention Description
40 ml volume of bupivacaine 0.25% only distributed as 30 ml intraperitoneally and 10 ml as port site infiltration
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.
Intervention Type
Drug
Intervention Name(s)
bupivacaine(intraperitoneally)
Intervention Description
40 ml volume of bupivacaine 0.25% only distributed as 30 ml intraperitoneally and 10 ml as port site infiltration
10 ml normal saline 0.9% will be given intravenous.
Primary Outcome Measure Information:
Title
Time to first given rescue analgesia(minutes)
Description
Time to first given rescue analgesia(minutes)
Time Frame
24 hours postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ibrahim Mamdouh Esmat
Phone
01001241928
Email
ibrahim_mamdouh@med.asu.edu.eg
Facility Information:
Facility Name
Ain-Shams University Hospitals
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ibrahim Mamdouh Esmat
Phone
01001241928
Email
ibrahim_mamdouh@med.asu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Preventive Ketamine on Postoperative Pain
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