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

Weill Medical College of Cornell University74 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Non-obstructive Azoospermia

Interventions

GabapentinDRUG

Gabapentin 600mg tablet

PlaceboDRUG

Placebo tablet

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Weill Cornell Medicine

New York, New York, United States

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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.

Time frame: 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

Time frame: 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

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.