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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Non-obstructive Azoospermia

Intervention / Treatment
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* Drug: Gabapentin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gabapentin<br>Participants receive Gabapentin 600mg tablet taken pre-operatively and 300mg taken three times a day for 3 days. | Drug: Gabapentin<br>* Gabapentin 600mg tablet<br>|
| Placebo Comparator: Placebo<br>Participants receive Placebo tablet taken pre-operatively and three times a day for 3 days | Drug: Placebo<br>* Placebo tablet<br>|

What is the study measuring?
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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 |