Non-obstructive AzoospermiaPhase 3NCT04230980

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

A Phase 3 study testing Gabapentin in people with Non-obstructive Azoospermia, run by Weill Medical College of Cornell University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Non-obstructive Azoospermia
What is being tested?: Gabapentin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 74 participants
Where: 1 siteUnited States
Study dates: 28 Jul 2020to 16 Dec 2022
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

Weill Cornell Medicine
New York, New York, 10065

Other trials in United States

About this study

Official title: The Use of 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.

Read the 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.

Conditions: Non-obstructive Azoospermia
Being tested: Gabapentin, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GabapentinDrug
Gabapentin 600mg tablet
PlaceboDrug
Placebo tablet

Study groups in NCT04230980
Study group	Role	What they receive
Gabapentin	Experimental	Participants receive Gabapentin 600mg tablet taken pre-operatively and 300mg taken three times a day for 3 days. Receives: Drug: Gabapentin
Placebo	Placebo comparator	Participants receive Placebo tablet taken pre-operatively and three times a day for 3 days Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Post-operative day 0 (the day of surgery, after surgery was completed) through post-operative day 7

Secondary outcomes (3)

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.
Measured: 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
Measured: 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
Measured: Post-operative day 0 (the day of surgery, after surgery was completed) through post-operative day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Jul 202016 Dec 2022

First posted18 Jan 2020
Study start28 Jul 2020
Primary completion28 Nov 2022
Study completion16 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Non-obstructive AzoospermiaStudies of the same condition, open and under way.
More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04230980
Sponsor's protocol ID: 19-08020686
Status last verified: Oct 2023
First submitted: 13 Jan 2020
Last updated: 18 Oct 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Punjani N, Marinaro JA, Kang C, Gal J, Rippon B, Jotwani R, Weinberg R, Schlegel PN. Gabapentin for Postoperative Pain Control and Opioid Reduction in Scrotal Surgery: A Randomized Controlled Clinical Trial. J Urol. 2024 May;211(5):658-666. doi: 10.1097/JU.0000000000003884. Epub 2024 Feb 21.
PubMed 38382042

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Use of Gabapentin for Post-Operative Pain Control and Narcotic Reduction in Scrotal Surgery
ClinicalTrials.gov ID: NCT04230980
Acronym / sponsor ID: 19-08020686
Conditions: Non-obstructive Azoospermia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 74 participants (actual)
Lead sponsor: Weill Medical College of Cornell UniversityUniversity, hospital or other
Study start: 28 Jul 2020 (actual)
Primary completion: 28 Nov 2022 (actual)
Study completion: 16 Dec 2022 (actual)
First posted: 18 Jan 2020 (actual)
Results: Posted 18 Oct 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Gabapentin	Experimental	Drug: GabapentinParticipants receive Gabapentin 600mg tablet taken pre-operatively and 300mg taken three times a day for 3 days.
Placebo	Placebo comparator	Drug: PlaceboParticipants receive Placebo tablet taken pre-operatively and three times a day for 3 days

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GabapentinGabapentin 600mg tablet	Drug	Gabapentin
PlaceboPlacebo tablet	Drug	Placebo

Primary outcome

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.

3 secondary outcomes

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
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
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

Results and safety

Results posted to the registry on 18 Oct 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Gabapentin	36	35
Placebo	38	35

Primary outcome: 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. Mean (Standard Deviation). Unit: scores on a scale

Measure	Gabapentin n = 35	Placebo n = 35
Post-Operative Day 0	1.91 (1.63)	3.05 (2.68)
Post-Operative Day 1, midnight	2.27 (1.55)	3.24 (2.7)
Post-Operative Day 1, before noon	2.02 (1.8)	3.33 (2.75)
Post-Operative Day 1, after noon	2.52 (1.88)	3.65 (2.6)
Post-Operative Day 2, midnight	2.19 (1.86)	3.83 (2.58)
Post-Operative Day 2, before noon	1.94 (1.42)	3.77 (2.94)
Post-Operative Day 2, after noon	1.81 (1.43)	3.5 (2.52)
Post-Operative Day 3, before noon	1.57 (1.55)	3.16 (2.39)

Gabapentin vs Placebo: Mean Difference (Final Values): -1.13 (95% CI -2.02 to -0.24), p = 0.01, t-test, 2 sided

Population analysed: 1 subject has been lost to followup in the gabapentin arm and was therefore excluded from analysis. 2 subjects have been lost to followup in the placebo arm and were therefore excluded from analysis. 1 subject experienced an adverse event in the placebo arm and was taken off the study medication and was therefore excluded from analysis.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: After surgery (post-operative day 0) through 2 weeks post-operatively.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Gabapentin	0 of 36 (0%)	16 of 36 (44.4%)	0 of 36
Placebo	2 of 38 (5.3%)	15 of 38 (39.5%)	0 of 38

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38382042Punjani N, Marinaro JA, Kang C, Gal J, Rippon B, Jotwani R, Weinberg R, Schlegel PN. Gabapentin for Postoperative Pain Control and Opioid Reduction in Scrotal Surgery: A Randomized Controlled Clinical Trial. J Urol. 2024 May;211(5):658-666. doi: 10.1097/JU.0000000000003884. Epub 2024 Feb 21.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jonathan Gal, M.D. principal investigator

Weill Medical College of Cornell University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Gabapentin in people with Non-obstructive Azoospermia, run by Weill Medical College of Cornell University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04230980, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.