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

Non-obstructive Azoospermia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04230980
• Other study ID #: 19-08020686
• Status: Completed
• Phase: Phase 3
• Start date: July 28, 2020
• Est. completion date: December 16, 2022

Study information

• Verified date: October 2023
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: December 16, 2022
• Est. primary completion date: November 28, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Azoospermia
• Non-obstructive Azoospermia
• Pain, Postoperative

Intervention

Drug:
• Gabapentin
Gabapentin 600mg tablet
• Placebo
Placebo tablet

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Post-operative day 0 (the day of surgery, after surgery was completed) through post-operative day 7
Secondary	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.	Post-operative day 0 (the day of surgery, after surgery was completed) through post-operative day 7
Secondary	Change in Narcotic Consumption, as Measured by Frequency of Narcotic Tablets Taken	Frequency of narcotic tablets that were taken after surgery	Post-operative day 0 (the day of surgery, after surgery was completed) through post-operative day 7
Secondary	Change in Narcotic Consumption, as Measured by Duration of Narcotic Tablets Consumption	Duration (time period) over which narcotic tablets that were consumed	Post-operative day 0 (the day of surgery, after surgery was completed) through post-operative day 7