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

NCT04230980 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: 19-08020686
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-obstructive Azoospermia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Opioid Consumption, as Measured by Number of Tablets Taken.

  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

  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

  Post-operative day 0 (the day of surgery, after surgery was completed) through post-operative day 7

Study Arms (2)

Gabapentin

EXPERIMENTAL

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

Drug: Gabapentin

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Gabapentin DRUG

Gabapentin 600mg tablet

Gabapentin

Placebo DRUG

Placebo tablet

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

MeSH Terms

Interventions

Gabapentin

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Grace Tan, Clinical Research Coordinator
• Organization: Weill Cornell Medical College

grt2008@med.cornell.edu

212-746-3208

Study Officials

• Jonathan Gal, M.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2020
• First Posted: January 18, 2020
• Study Start: July 28, 2020
• Primary Completion: November 28, 2022
• Study Completion: December 16, 2022
• Last Updated: October 18, 2023
• Results First Posted: October 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)