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CompletedNCT04230980Updated Oct 18, 2023Results posted

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

A Phase 3 interventional study of Gabapentin and Placebo in Non-obstructive Azoospermia, sponsored by Weill Medical College of Cornell University. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-18.

Sponsored by Weill Medical College of Cornell University · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
74
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study 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.

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.

02

Conditions studied

  • Non-obstructive Azoospermia

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03

In context

Azoospermia

59 studies on the registry are indexed under Azoospermia; 17 are open to participants now.

This study's enrollment of 74 is above the median of 57 across 32 interventional studies indexed under Azoospermia.

Browse Azoospermia studies →

Lead sponsor

Weill Medical College of Cornell University is the lead sponsor of 892 studies on the registry; 165 are open to participants now.

Of its 123 completed or terminated interventional studies of FDA-regulated products, 94 (76%) have results posted.

Browse Weill Medical College of Cornell University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participants undergoing microsurgical testicular sperm extraction.
  • Participants over 18 years of age who can provide
  • Participants with no to the consumption gabapentin or documented allergy/intolerance
  • Participants not currently using opiates for another reason

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
74 participants (actual)

Study arms

  • Experimental
    Gabapentin

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

    Drug: Gabapentin

  • Placebo comparator
    Placebo

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

    Drug: Placebo

Interventions

  • DrugGabapentin

    Gabapentin 600mg tablet

  • DrugPlacebo

    Placebo tablet

06

What researchers measure

Primary outcomes

  1. 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.

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

Secondary outcomes

  1. 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.

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

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

    Frequency of narcotic tablets that were taken after surgery

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

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

    Duration (time period) over which narcotic tablets that were consumed

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

07

Results

Posted Oct 18, 2023

Participant flow

Participant flow — Overall Study
MilestoneGabapentinPlacebo
Started3638
Completed3535
Not completed13
Withdrew: Lost to follow-up12
Withdrew: Adverse event01

Outcome measures

PrimaryPain 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.

Time frame:
Post-operative day 0 (the day of surgery, after surgery was completed) through post-operative day 7
Reported as:
Mean · scores on a scale
Pain Score as Measured by the NRS-11 Scale
scores on a scaleGabapentinPlacebo
Post-Operative Day 01.91 ± 1.633.05 ± 2.68
Post-Operative Day 1, midnight2.27 ± 1.553.24 ± 2.7
Post-Operative Day 1, before noon2.02 ± 1.83.33 ± 2.75
Post-Operative Day 1, after noon2.52 ± 1.883.65 ± 2.6
Post-Operative Day 2, midnight2.19 ± 1.863.83 ± 2.58
Post-Operative Day 2, before noon1.94 ± 1.423.77 ± 2.94
Post-Operative Day 2, after noon1.81 ± 1.433.5 ± 2.52
Post-Operative Day 3, before noon1.57 ± 1.553.16 ± 2.39
Post-Operative Day 3, after noon1.56 ± 1.512.98 ± 2.39
Post-Operative Day 4, before noon1.14 ± 1.192.44 ± 2.02
Post-Operative Day 4, after noon1.29 ± 1.472.93 ± 2.58
Post-Operative Day 5, before noon1.64 ± 1.882.54 ± 1.88
Post-Operative Day 5, after noon1.48 ± 1.82.79 ± 2.14
Post-Operative Day 6, before noon1.56 ± 2.412.26 ± 2.11
Post-Operative Day 6, after noon1.41 ± 2.342.50 ± 2.19
Post-Operative Day 7, before noon1.36 ± 2.382.25 ± 2.14
Post-Operative Day 7, after noon.99 ± 1.42.12 ± 2.24
Statistical analysis
  • Gabapentin vs Placebo · t-test, 2 sided · p = 0.01 · Mean difference (final values): -1.13 · 95% CI -2.02 to -0.24Direction of mean difference is Gabapentin arm minus placebo arm.
SecondaryOpioid 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.

Time frame:
Post-operative day 0 (the day of surgery, after surgery was completed) through post-operative day 7
Reported as:
Mean · Number of oxycodone 5mg tablets consumed
Opioid Consumption, as Measured by Number of Tablets Taken.
Number of oxycodone 5mg tablets consumedGabapentinPlacebo
Post-Operative Day 01.11 ± .321.54 ± 1.31
Post-Operative Day 1, midnight1.14 ± .431.24 ± .74
Post-Operative Day 1, before noon1.2 ± .471.38 ± .98
Post-Operative Day 1, after noon1.14 ± .361.27 ± .52
Post-Operative Day 2, midnight1.18 ± .391.23 ± .63
Post-Operative Day 2, before noon1.18 ± .521.48 ± 1.06
Post-Operative Day 2, after noon1.12 ± .331.52 ± 1.7
Post-Operative Day 3, before noon1.09 ± .291.2 ± .48
Post-Operative Day 3, after noon1.09 ± 0.291.11 ± 0.32
Post-Operative Day 4, before noon1.06 ± 0.241.10 ± 0.31
Post-Operative Day 4, after noon1.03 ± 0.171.00 ± 0.00
Post-Operative Day 5, before noon1.00 ± 0.001.00 ± 0.00
Post-Operative Day 5, after noon1.07 ± 0.261.08 ± 0.28
Post-Operative Day 6, before noon1.00 ± 0.001.12 ± 0.33
Post-Operative Day 6, after noon1.00 ± 0.001.04 ± 0.20
Post-Operative Day 7, before noon1 ± 01.05 ± .21
Post-Operative Day 7, after noon1 ± 01.05 ± .22
Statistical analysis
  • Gabapentin vs Placebo · t-test, 2 sided · p = 0.19 · Mean difference (final values): -0.05 · 95% CI -0.13 to 0.03Direction of mean difference is Gabapentin arm minus placebo arm.
SecondaryChange in Narcotic Consumption, as Measured by Frequency of Narcotic Tablets Taken

Frequency of narcotic tablets that were taken after surgery

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

No measurements were reported for this outcome.

SecondaryChange in Narcotic Consumption, as Measured by Duration of Narcotic Tablets Consumption

Duration (time period) over which narcotic tablets that were consumed

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

No measurements were reported for this outcome.

Adverse events

Collected over After surgery (post-operative day 0) through 2 weeks post-operatively.. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Gabapentin0/36 (0%)0/36 (0%)16/36 (44.4%)
Placebo0/38 (0%)2/38 (5.3%)15/38 (39.5%)
Most frequent serious events
Most frequent serious events
EventGabapentinPlacebo
syncopal episodeGeneral disorders0/362/38
Most frequent other events
Showing 10 of 15
Most frequent other events
EventGabapentinPlacebo
GI upset (abdominal pain, bloating, heartburn)Gastrointestinal disorders4/369/38
ParesthesiaNervous system disorders5/363/38
DizzinessGeneral disorders5/361/38
Somnolence, drowsinessGeneral disorders4/361/38
ConstipationGastrointestinal disorders2/363/38
LightheadednessGeneral disorders1/363/38
NauseaGastrointestinal disorders2/361/38
WeaknessMusculoskeletal and connective tissue disorders2/360/38
HeadacheNervous system disorders1/362/38
Blurry visionNervous system disorders1/360/38

Baseline characteristics

1 subject on the gabapentin arm and 3 subjects on the placebo arm were excluded as data collected from these participants was insufficient for analysis.

Age, Continuous
Age, Continuous(years)GabapentinPlaceboTotal
Mean38 ± 10.134.9 ± 7.136.5 ± 8.8
Sex: Female, Male
Sex: Female, Male(Participants)GabapentinPlaceboTotal
Female000
Male353570
Race (NIH/OMB)
Race (NIH/OMB)(Participants)GabapentinPlaceboTotal
American Indian or Alaska Native000
Asian347
Native Hawaiian or Other Pacific Islander000
Black or African American336
White252651
More than one race000
Unknown or Not Reported426
Region of Enrollment
Region of Enrollment(participants)GabapentinPlaceboTotal
United States353570
08

Study locations

1 site
  • Weill Cornell Medicine
    New York, New York 10065, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2020 to primary completion in Nov 2022, 28 months.

Results were first posted in Oct 2023, 10 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 13, 2020
First posted
Jan 18, 2020
StartActual
Jul 28, 2020
Primary completionActual
Nov 28, 2022
CompletionActual
Dec 16, 2022
Results first posted
Oct 18, 2023
Last update
Oct 18, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04230980
Lead sponsor
Weill Medical College of Cornell University
Responsible party
Sponsor
First posted
Jan 18, 2020
Start date
Jul 28, 2020
Primary completion
Nov 28, 2022
Completion
Dec 16, 2022
Results posted
Oct 18, 2023
Last update
Oct 18, 2023

Study contacts

Jonathan Gal, M.D.
principal investigator · Weill Medical College of Cornell University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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