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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
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

First Posted
May 27, 2021
Last Updated
July 20, 2023
Sponsor
Ain Shams University
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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

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Efficacy of Preventive Ketamine on Postoperative Pain

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