Clinical trial NCT04230980: Gabapentin for Post-Operative Pain Control and Narcotic Reduction in Scrotal Surgery
Official title: The Use of Gabapentin for Post-Operative Pain Control and Narcotic Reduction in Scrotal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-obstructive Azoospermia
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 74
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain Score as Measured by the NRS-11 Scale
timeFrame: Post-operative day 0 (the day of surgery, after surgery was completed) through post-operative day 7
Secondary outcomes:
measure: Opioid Consumption, as Measured by Number of Tablets Taken.
timeFrame: Post-operative day 0 (the day of surgery, after surgery was completed) through post-operative day 7
measure: Change in Narcotic Consumption, as Measured by Frequency of Narcotic Tablets Taken
timeFrame: Post-operative day 0 (the day of surgery, after surgery was completed) through post-operative day 7
measure: Change in Narcotic Consumption, as Measured by Duration of Narcotic Tablets Consumption
timeFrame: Post-operative day 0 (the day of surgery, after surgery was completed) through post-operative day 7
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Jonathan Gal, M.D.
role: PRINCIPAL_INVESTIGATOR
References: