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

Weill Cornell Medicine (WCM)

Status and phase: Completed; Phase 3

Conditions: Non-obstructive Azoospermia

Treatments: Drug: Placebo; Drug: Gabapentin

Study type: Interventional

Funder types: Other

Identifiers

NCT04230980

19-08020686

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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74 participants in 2 patient groups, including a placebo group

Gabapentin

Experimental group

Description:

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

Treatment:

Drug: Gabapentin

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo