Phase 3
N=74
Gabapentin for Post-Operative Pain Control and Narcotic Reduction in Scrotal Surgery
Non-obstructive Azoospermia
Bottom Line
View on ClinicalTrials.gov: NCT04230980 ↗Enrolled (actual)
74
Serious AEs
2.7%
Results posted
Oct 2023
Primary outcome: Primary: Pain Score as Measured by the NRS-11 Scale — 1.91; 3.05; 2.27; 3.24 scores on a scale — p=0.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Gabapentin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Weill Medical College of Cornell University
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Score as Measured by the NRS-11 Scale |
1.91; 3.05; 2.27; 3.24; 2.02; 3.33 | 0.01 sig |
| SECONDARY Opioid Consumption, as Measured by Number of Tablets Taken. |
1.11; 1.54; 1.14; 1.24; 1.2; 1.38 | 0.19 |
| SECONDARY Change in Narcotic Consumption, as Measured by Frequency of Narcotic Tablets Taken |
— | — |
| SECONDARY Change in Narcotic Consumption, as Measured by Duration of Narcotic Tablets Consumption |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04230980). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.