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

NCT ID: NCT04230980

Last Updated: 2023-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-28
• Study Completion Date: 2022-12-16

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.

Conditions

Non-obstructive Azoospermia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Gabapentin

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

Group Type: EXPERIMENTAL

Gabapentin

Intervention Type: DRUG

Gabapentin 600mg tablet

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo tablet

Interventions

Gabapentin

Gabapentin 600mg tablet

Intervention Type: DRUG

Placebo

Placebo tablet

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan Gal, M.D.

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Weill Cornell Medicine

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

19-08020686

Identifier Type: -

Identifier Source: org_study_id