Back to resultsOptimizing Postoperative Pain Control After Laparoscopic Colorectal Surgery
Primary Purpose
Postoperative Pain
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Bupivacaine and ketamine
Bupivacaine and transdermal fentanyl patch
Bupivacain
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria: Patients undergoing laparoscopic colorectal surgery. American Society of Anesthesiologists (ASA) physical status I or II. Exclusion Criteria: Known allergy to one of the study medications. Skin infections at the site of the needle puncture. Hepatic, renal or cardiac dysfunction. Patients diagnosed with obstructive sleep apnoea
Sites / Locations
- Ain-Shams University HospitalsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Bupivacaine and ketamine
Bupivacaine and transdermal fentanyl patch
Bupivacaine
Arm Description
Outcomes
Primary Outcome Measures
The total rescue analgesia consumption (mg)
The total rescue analgesia consumption (mg) in the first 48 hours after surgery
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06007378
Brief Title
Optimizing Postoperative Pain Control After Laparoscopic Colorectal Surgery
Official Title
Optimizing Postoperative Pain Control After Laparoscopic Colorectal Surgery by Supplementing Ultrasound-guided Erector Spinae Plane Block With Ketamine or Transdermal Fentanyl Patch
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 5, 2023 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (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
Erector spinae plane block (ESPB) is a novel regional block technique that was proven to have superior outcomes in relieving postoperative pain in colorectal surgeries.Ketamine enhances the impact of local anaesthetics by reducing the duration and extent of motor block while shortening the onset of sensory and motor block.Transdermal Fentanyl Patch (TFP) was better than transdermal buprenorphine in postoperative analgesia following abdominal surgeries.
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
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bupivacaine and ketamine
Arm Type
Other
Arm Title
Bupivacaine and transdermal fentanyl patch
Arm Type
Other
Arm Title
Bupivacaine
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Bupivacaine and ketamine
Intervention Description
Bilateral erector spinae plane block (bupivacaine and ketamine)
Intervention Type
Other
Intervention Name(s)
Bupivacaine and transdermal fentanyl patch
Intervention Description
Bilateral erector spinae plane block (bupivacaine) and transdermal fentanyl patch
Intervention Type
Other
Intervention Name(s)
Bupivacain
Intervention Description
Bilateral erector spinae plane block (bupivacaine)
Primary Outcome Measure Information:
Title
The total rescue analgesia consumption (mg)
Description
The total rescue analgesia consumption (mg) in the first 48 hours after surgery
Time Frame
in the first 48 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing laparoscopic colorectal surgery.
American Society of Anesthesiologists (ASA) physical status I or II.
Exclusion Criteria:
Known allergy to one of the study medications.
Skin infections at the site of the needle puncture.
Hepatic, renal or cardiac dysfunction.
Patients diagnosed with obstructive sleep apnoea
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
Learn more about this trial
Optimizing Postoperative Pain Control After Laparoscopic Colorectal Surgery
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