Back to resultsGabapentin for Post-Operative Pain Control and Narcotic Reduction in Scrotal Surgery
Primary Purpose
Non-obstructive Azoospermia
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Gabapentin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Non-obstructive Azoospermia
Eligibility Criteria
Inclusion Criteria:
- Participants undergoing microsurgical testicular sperm extraction.
- Participants over 18 years of age who can provide informed consent
- Participants with no contraindication to the consumption gabapentin or documented allergy/intolerance
- Participants not currently using opiates for another reason
Exclusion Criteria:
- Contraindication to the consumption of celecoxib or gabapentin
- History of substance abuse (including prior opiate abuse)
- Narcotic use within last 3 months
- Any of the following comorbidities: renal failure, heart disease, peptic ulcer disease, cerebrovascular disease, significant liver disease, untreated depression, chronic pain disorder, or bleeding diatheses
- Medical history or concurrent illness that the investigator considers sufficiently serious to interfere with the conduct, completion, or results of this trial, or constitutes an unacceptable risk to the subject
Sites / Locations
- Weill Cornell Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Gabapentin
Placebo
Arm Description
Participants receive Gabapentin 600mg tablet taken pre-operatively and 300mg taken three times a day for 3 days.
Participants receive Placebo tablet taken pre-operatively and three times a day for 3 days
Outcomes
Primary Outcome Measures
Pain Score as Measured by the NRS-11 Scale
The Numerical pain Rating Scale (NRS-11) is an 11-point numerical pain rating scale used to measure levels of pain. The lowest possible score is 0 with 0 meaning no pain, and the highest possible score is 10 with 10 meaning severe pain.
Secondary Outcome Measures
Opioid Consumption, as Measured by Number of Tablets Taken.
Participants were requested to self-report the number of opioid tablets (oxycodone, 5mg) that they had taken since the last survey.
Change in Narcotic Consumption, as Measured by Frequency of Narcotic Tablets Taken
Frequency of narcotic tablets that were taken after surgery
Change in Narcotic Consumption, as Measured by Duration of Narcotic Tablets Consumption
Duration (time period) over which narcotic tablets that were consumed
Full Information
NCT ID
NCT04230980
First Posted
January 13, 2020
Last Updated
October 17, 2023
Sponsor
Weill Medical College of Cornell University
1. Study Identification
Unique Protocol Identification Number
NCT04230980
Brief Title
Gabapentin for Post-Operative Pain Control and Narcotic Reduction in Scrotal Surgery
Official Title
The Use of Gabapentin for Post-Operative Pain Control and Narcotic Reduction in Scrotal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
July 28, 2020 (Actual)
Primary Completion Date
November 28, 2022 (Actual)
Study Completion Date
December 16, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The use of non-narcotic multi-modal analgesia to be used in the pre-operative, peri-operative and post-operative period to reduce or potentially eliminate narcotic usage following scrotal surgery. Research study results have shown that the use of anti-inflammatories in the peri-operative period reduces both pain and narcotic use. The hypothesis is that adding another agent in the multi-modal pathway will further reduce pain and potentially reduce narcotic usage.
Detailed Description
This is a double-blinded, placebo-controlled, randomized trial that will recruit patients categorized into two study arms. Patients in the gabapentin arm will receive gabapentin 600mg taken pre-operatively and 300mg taken three times a day for 3 days, while patients in the placebo arm will receive a placebo drug taken pre-operatively three times a day for 3 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-obstructive Azoospermia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gabapentin
Arm Type
Experimental
Arm Description
Participants receive Gabapentin 600mg tablet taken pre-operatively and 300mg taken three times a day for 3 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants receive Placebo tablet taken pre-operatively and three times a day for 3 days
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Description
Gabapentin 600mg tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet
Primary Outcome Measure Information:
Title
Pain Score as Measured by the NRS-11 Scale
Description
The Numerical pain Rating Scale (NRS-11) is an 11-point numerical pain rating scale used to measure levels of pain. The lowest possible score is 0 with 0 meaning no pain, and the highest possible score is 10 with 10 meaning severe pain.
Time Frame
Post-operative day 0 (the day of surgery, after surgery was completed) through post-operative day 7
Secondary Outcome Measure Information:
Title
Opioid Consumption, as Measured by Number of Tablets Taken.
Description
Participants were requested to self-report the number of opioid tablets (oxycodone, 5mg) that they had taken since the last survey.
Time Frame
Post-operative day 0 (the day of surgery, after surgery was completed) through post-operative day 7
Title
Change in Narcotic Consumption, as Measured by Frequency of Narcotic Tablets Taken
Description
Frequency of narcotic tablets that were taken after surgery
Time Frame
Post-operative day 0 (the day of surgery, after surgery was completed) through post-operative day 7
Title
Change in Narcotic Consumption, as Measured by Duration of Narcotic Tablets Consumption
Description
Duration (time period) over which narcotic tablets that were consumed
Time Frame
Post-operative day 0 (the day of surgery, after surgery was completed) through post-operative day 7
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants undergoing microsurgical testicular sperm extraction.
Participants over 18 years of age who can provide informed consent
Participants with no contraindication to the consumption gabapentin or documented allergy/intolerance
Participants not currently using opiates for another reason
Exclusion Criteria:
Contraindication to the consumption of celecoxib or gabapentin
History of substance abuse (including prior opiate abuse)
Narcotic use within last 3 months
Any of the following comorbidities: renal failure, heart disease, peptic ulcer disease, cerebrovascular disease, significant liver disease, untreated depression, chronic pain disorder, or bleeding diatheses
Medical history or concurrent illness that the investigator considers sufficiently serious to interfere with the conduct, completion, or results of this trial, or constitutes an unacceptable risk to the subject
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Gal, M.D.
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Gabapentin for Post-Operative Pain Control and Narcotic Reduction in Scrotal Surgery
We'll reach out to this number within 24 hrs