Gabapentin for Post-Operative Pain Control and Narcotic Reduction in Scrotal Surgery

Sponsor

Weill Medical College of Cornell University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04230980

Collaborator

(none)

Enrollment

Location

Arms

28.1

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Non-obstructive Azoospermia	Drug: Gabapentin Drug: Placebo	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Use of Gabapentin for Post-Operative Pain Control and Narcotic Reduction in Scrotal Surgery

Actual Study Start Date :

Jul 28, 2020

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Gabapentin Participants receive Gabapentin 600mg tablet taken pre-operatively and 300mg taken three times a day for 3 days.	Drug: Gabapentin Gabapentin 600mg tablet
Placebo Comparator: Placebo Participants receive Placebo tablet taken pre-operatively and three times a day for 3 days	Drug: Placebo Placebo tablet

Arm

Intervention/Treatment

Experimental: Gabapentin

Participants receive Gabapentin 600mg tablet taken pre-operatively and 300mg taken three times a day for 3 days.

Drug: Gabapentin

Gabapentin 600mg tablet

Placebo Comparator: Placebo

Participants receive Placebo tablet taken pre-operatively and three times a day for 3 days

Drug: Placebo

Placebo tablet

Outcome Measures

Primary Outcome Measures

Change in Pain as measured by the NRS 1-11 [Level of pain will be measured on day of surgery (Day 1), and post-operative days 1 through 7]
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

Change in narcotic consumption, as measured by number of tablets taken. [Number of tablets will be measured on day of surgery (Day 1), and post-operative days 1 through 7]
Number of narcotic tablets that were consumed after surgery
Change in narcotic consumption, as measured by frequency of narcotic tablets taken [Frequency of tablets will be measured on day of surgery (Day 1), and post-operative days 1 through 7]
Frequency of narcotic tablets that were taken after surgery
Change in narcotic consumption, as measured by duration of narcotic tablets consumption [Duration of narcotic tablets consumed will be measured on day of surgery (Day 1), and post-operative days 1 through 7]
Duration (time period) over which narcotic tablets that were consumed

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Weill Cornell Medicine	New York	New York	United States	10065

Sponsors and Collaborators

Weill Medical College of Cornell University

Investigators

Principal Investigator: Caroline Kang, M.D., Weill Medical College of Cornell University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Weill Medical College of Cornell University

ClinicalTrials.gov Identifier:

NCT04230980

Other Study ID Numbers:

19-08020686

First Posted:

Jan 18, 2020

Last Update Posted:

Sep 22, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Azoospermia

Pain, Postoperative

Gabapentin

Study Results

No Results Posted as of Sep 22, 2021