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

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

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.

Study Overview

• Status: Completed
• Conditions: Non-obstructive Azoospermia
• Intervention / Treatment: Drug: Placebo; Drug: Gabapentin

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 Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Jonathan Gal, M.D., Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2020
• Primary Completion (Actual): November 28, 2022
• Study Completion (Actual): December 16, 2022

Study Registration Dates

• First Submitted: January 13, 2020
• First Submitted That Met QC Criteria: January 13, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Infertility, Male; Infertility; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Pain, Postoperative; Azoospermia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Gabapentin
• Other Study ID Numbers: 19-08020686

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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