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

Phase 3

Completed

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.

Recruitment & 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

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Pain Score as Measured by the NRS-11 Scale	Post-operative day 0 (the day of surgery, after surgery was completed) through post-operative day 7	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.

Secondary Outcome Measures

Name	Time	Method
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	Participants were requested to self-report the number of opioid tablets (oxycodone, 5mg) that they had taken since the last survey.
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	Frequency of narcotic tablets that were taken after surgery
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	Duration (time period) over which narcotic tablets that were consumed