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Completed

NCT Number: NCT04230980

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

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.

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Key information

Conditions

Non-obstructive Azoospermia

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Weill Cornell Medicine

New York, 10065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gabapentin

Drug

Gabapentin 600mg tablet

Placebo

Drug

Placebo tablet

Primary outcomes

  1. Pain Score as Measured by the NRS-11 Scale

    Time frame: 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 outcomes

  1. Opioid Consumption, as Measured by Number of Tablets Taken.

    Time frame: 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.

  2. Change in Narcotic Consumption, as Measured by Frequency of Narcotic Tablets Taken

    Time frame: 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

  3. Change in Narcotic Consumption, as Measured by Duration of Narcotic Tablets Consumption

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 18, 2020
Registry last updated
Oct 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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