Back to resultsA Single Preoperative Dose of Gabapentin to Decreases Postoperative Pain in Ambulatory Anal Surgeries
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Gabapentin
Sponsored by
About this trial
This is an interventional supportive care trial for Pain, Postoperative focused on measuring anal surgery,, gabapentin,, postoperative pain
Eligibility Criteria
Inclusion Criteria:
- ASA physical status I or II
- Aged from 18 to 65 years
- Scheduled for anal surgeries at Minya University Hospital
Exclusion Criteria:
- Presence of contraindications to neuraxial anesthesia
- Presence of history of central nervous system or mental disorders, epilepsy, chronic pain, or drug abuse.
- The use of neuropathic analgesic or antiepileptic drugs
Sites / Locations
- Sarah Omar
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Other
Arm Label
postoperative pain
total analgesic consumption
Arm Description
Measuring postoperative pain using the visual analogue scale
Recording the total amount of analgesia consumed by the patients
Outcomes
Primary Outcome Measures
postoperative pain
measuring postoperative pain using the visual analog scale from 0 to 10, where zero is the least, and 10 is the worst pain
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05533684
Brief Title
A Single Preoperative Dose of Gabapentin to Decreases Postoperative Pain in Ambulatory Anal Surgeries
Official Title
A Single Preoperative Dose of Gabapentin to Decreases Postoperative Pain in Ambulatory Anal Surgeries
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Single dose 600 mg gabapentin will be given preoperatively in anal surgeries
Detailed Description
Patients will be grouped into 2 groups of 25 patients each, the first group will receive 600 mg of gabapentin one hour before surgery and the second group will receive a placebo tablet. pain scores will be measured postoperatively
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
anal surgery,, gabapentin,, postoperative pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
2 groups are included in the study
Masking
ParticipantInvestigator
Masking Description
double-blinded study both participant and investigator are blind to the study drug
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
postoperative pain
Arm Type
No Intervention
Arm Description
Measuring postoperative pain using the visual analogue scale
Arm Title
total analgesic consumption
Arm Type
Other
Arm Description
Recording the total amount of analgesia consumed by the patients
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Other Intervention Name(s)
Gaptin 600 mg
Intervention Description
single preoperative dose of 600 mg gabapentin
Primary Outcome Measure Information:
Title
postoperative pain
Description
measuring postoperative pain using the visual analog scale from 0 to 10, where zero is the least, and 10 is the worst pain
Time Frame
first 12 hours postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA physical status I or II
Aged from 18 to 65 years
Scheduled for anal surgeries at Minya University Hospital
Exclusion Criteria:
Presence of contraindications to neuraxial anesthesia
Presence of history of central nervous system or mental disorders, epilepsy, chronic pain, or drug abuse.
The use of neuropathic analgesic or antiepileptic drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Omar, M.D.
Organizational Affiliation
Minia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sarah Omar
City
Minya
ZIP/Postal Code
61111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The research will be available to other researchers when it is completed
Learn more about this trial
A Single Preoperative Dose of Gabapentin to Decreases Postoperative Pain in Ambulatory Anal Surgeries
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