Non-obstructive Azoospermia
Conditions
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.
Interventions
DRUGGabapentin
Gabapentin 600mg tablet
DRUGPlacebo
Placebo tablet
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score as Measured by the NRS-11 Scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption, as Measured by Number of Tablets Taken. | 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. |
| Change in Narcotic Consumption, as Measured by Frequency of Narcotic Tablets Taken | 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 |
| Change in Narcotic Consumption, as Measured by Duration of Narcotic Tablets Consumption | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Gabapentin Participants receive Gabapentin 600mg tablet taken pre-operatively and 300mg taken three times a day for 3 days.
Gabapentin: Gabapentin 600mg tablet | 35 |
| Placebo Participants receive Placebo tablet taken pre-operatively and three times a day for 3 days
Placebo: Placebo tablet | 35 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 2 |
Baseline characteristics
| Characteristic | Gabapentin | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 38 years STANDARD_DEVIATION 10.1 | 36.5 years STANDARD_DEVIATION 8.8 | 34.9 years STANDARD_DEVIATION 7.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) White | 25 Participants | 51 Participants | 26 Participants |
| Region of Enrollment United States | 35 participants | 70 participants | 35 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 35 Participants | 70 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 38 |
| other Total, other adverse events | 16 / 36 | 15 / 38 |
| serious Total, serious adverse events | 0 / 36 | 2 / 38 |
Outcome results
Primary
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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gabapentin | Pain Score as Measured by the NRS-11 Scale | Post-Operative Day 2, midnight | 2.19 scores on a scale | Standard Deviation 1.86 |
| Gabapentin | Pain Score as Measured by the NRS-11 Scale | Post-Operative Day 6, after noon | 1.41 scores on a scale | Standard Deviation 2.34 |
| Gabapentin | Pain Score as Measured by the NRS-11 Scale | Post-Operative Day 3, after noon | 1.56 scores on a scale | Standard Deviation 1.51 |
| Gabapentin | Pain Score as Measured by the NRS-11 Scale | Post-Operative Day 7, before noon | 1.36 scores on a scale | Standard Deviation 2.38 |
| Gabapentin | Pain Score as Measured by the NRS-11 Scale | Post-Operative Day 2, after noon | 1.81 scores on a scale | Standard Deviation 1.43 |
| Gabapentin | Pain Score as Measured by the NRS-11 Scale | Post-Operative Day 7, after noon | .99 scores on a scale | Standard Deviation 1.4 |
| Gabapentin | Pain Score as Measured by the NRS-11 Scale | Post-Operative Day 4, before noon | 1.14 scores on a scale | Standard Deviation 1.19 |
| Gabapentin | Pain Score as Measured by the NRS-11 Scale | Post-Operative Day 0 | 1.91 scores on a scale | Standard Deviation 1.63 |
| Gabapentin | Pain Score as Measured by the NRS-11 Scale | Post-Operative Day 1, after noon | 2.52 scores on a scale | Standard Deviation 1.88 |
| Gabapentin | Pain Score as Measured by the NRS-11 Scale | Post-Operative Day 1, midnight | 2.27 scores on a scale | Standard Deviation 1.55 |
| Gabapentin | Pain Score as Measured by the NRS-11 Scale | Post-Operative Day 1, before noon | 2.02 scores on a scale | Standard Deviation 1.8 |
| Gabapentin | Pain Score as Measured by the NRS-11 Scale | Post-Operative Day 4, after noon | 1.29 scores on a scale | Standard Deviation 1.47 |
| Gabapentin | Pain Score as Measured by the NRS-11 Scale | Post-Operative Day 2, before noon | 1.94 scores on a scale | Standard Deviation 1.42 |
| Gabapentin | Pain Score as Measured by the NRS-11 Scale | Post-Operative Day 3, before noon | 1.57 scores on a scale | Standard Deviation 1.55 |
| Gabapentin | Pain Score as Measured by the NRS-11 Scale | Post-Operative Day 5, before noon | 1.64 scores on a scale | Standard Deviation 1.88 |
| Gabapentin | Pain Score as Measured by the NRS-11 Scale | Post-Operative Day 6, before noon | 1.56 scores on a scale | Standard Deviation 2.41 |
| Gabapentin | Pain Score as Measured by the NRS-11 Scale | Post-Operative Day 5, after noon | 1.48 scores on a scale | Standard Deviation 1.8 |
| Placebo | Pain Score as Measured by the NRS-11 Scale | Post-Operative Day 6, before noon | 2.26 scores on a scale | Standard Deviation 2.11 |
| Placebo | Pain Score as Measured by the NRS-11 Scale | Post-Operative Day 1, after noon | 3.65 scores on a scale | Standard Deviation 2.6 |
| Placebo | Pain Score as Measured by the NRS-11 Scale | Post-Operative Day 2, midnight | 3.83 scores on a scale | Standard Deviation 2.58 |
| Placebo | Pain Score as Measured by the NRS-11 Scale | Post-Operative Day 2, before noon | 3.77 scores on a scale | Standard Deviation 2.94 |
| Placebo | Pain Score as Measured by the NRS-11 Scale | Post-Operative Day 2, after noon | 3.5 scores on a scale | Standard Deviation 2.52 |
| Placebo | Pain Score as Measured by the NRS-11 Scale | Post-Operative Day 3, before noon | 3.16 scores on a scale | Standard Deviation 2.39 |
| Placebo | Pain Score as Measured by the NRS-11 Scale | Post-Operative Day 3, after noon | 2.98 scores on a scale | Standard Deviation 2.39 |
| Placebo | Pain Score as Measured by the NRS-11 Scale | Post-Operative Day 4, before noon | 2.44 scores on a scale | Standard Deviation 2.02 |
| Placebo | Pain Score as Measured by the NRS-11 Scale | Post-Operative Day 5, after noon | 2.79 scores on a scale | Standard Deviation 2.14 |
| Placebo | Pain Score as Measured by the NRS-11 Scale | Post-Operative Day 1, midnight | 3.24 scores on a scale | Standard Deviation 2.7 |
| Placebo | Pain Score as Measured by the NRS-11 Scale | Post-Operative Day 6, after noon | 2.50 scores on a scale | Standard Deviation 2.19 |
| Placebo | Pain Score as Measured by the NRS-11 Scale | Post-Operative Day 7, before noon | 2.25 scores on a scale | Standard Deviation 2.14 |
| Placebo | Pain Score as Measured by the NRS-11 Scale | Post-Operative Day 7, after noon | 2.12 scores on a scale | Standard Deviation 2.24 |
| Placebo | Pain Score as Measured by the NRS-11 Scale | Post-Operative Day 0 | 3.05 scores on a scale | Standard Deviation 2.68 |
| Placebo | Pain Score as Measured by the NRS-11 Scale | Post-Operative Day 1, before noon | 3.33 scores on a scale | Standard Deviation 2.75 |
| Placebo | Pain Score as Measured by the NRS-11 Scale | Post-Operative Day 4, after noon | 2.93 scores on a scale | Standard Deviation 2.58 |
| Placebo | Pain Score as Measured by the NRS-11 Scale | Post-Operative Day 5, before noon | 2.54 scores on a scale | Standard Deviation 1.88 |
Comparison: Mean NRS-11 score at post-operative day 7 (compared between the two arms).p-value: 0.0195% CI: [-2.02, -0.24]t-test, 2 sided
Secondary
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
Population: Data was not collected for this measure.
Secondary
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
Population: Data was not collected for this measure.
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gabapentin | Opioid Consumption, as Measured by Number of Tablets Taken. | Post-Operative Day 0 | 1.11 Number of oxycodone 5mg tablets consumed | Standard Deviation 0.32 |
| Gabapentin | Opioid Consumption, as Measured by Number of Tablets Taken. | Post-Operative Day 1, before noon | 1.2 Number of oxycodone 5mg tablets consumed | Standard Deviation 0.47 |
| Gabapentin | Opioid Consumption, as Measured by Number of Tablets Taken. | Post-Operative Day 1, after noon | 1.14 Number of oxycodone 5mg tablets consumed | Standard Deviation 0.36 |
| Gabapentin | Opioid Consumption, as Measured by Number of Tablets Taken. | Post-Operative Day 2, midnight | 1.18 Number of oxycodone 5mg tablets consumed | Standard Deviation 0.39 |
| Gabapentin | Opioid Consumption, as Measured by Number of Tablets Taken. | Post-Operative Day 2, before noon | 1.18 Number of oxycodone 5mg tablets consumed | Standard Deviation 0.52 |
| Gabapentin | Opioid Consumption, as Measured by Number of Tablets Taken. | Post-Operative Day 2, after noon | 1.12 Number of oxycodone 5mg tablets consumed | Standard Deviation 0.33 |
| Gabapentin | Opioid Consumption, as Measured by Number of Tablets Taken. | Post-Operative Day 3, before noon | 1.09 Number of oxycodone 5mg tablets consumed | Standard Deviation 0.29 |
| Gabapentin | Opioid Consumption, as Measured by Number of Tablets Taken. | Post-Operative Day 3, after noon | 1.09 Number of oxycodone 5mg tablets consumed | Standard Deviation 0.29 |
| Gabapentin | Opioid Consumption, as Measured by Number of Tablets Taken. | Post-Operative Day 4, before noon | 1.06 Number of oxycodone 5mg tablets consumed | Standard Deviation 0.24 |
| Gabapentin | Opioid Consumption, as Measured by Number of Tablets Taken. | Post-Operative Day 4, after noon | 1.03 Number of oxycodone 5mg tablets consumed | Standard Deviation 0.17 |
| Gabapentin | Opioid Consumption, as Measured by Number of Tablets Taken. | Post-Operative Day 5, before noon | 1.00 Number of oxycodone 5mg tablets consumed | Standard Deviation 0 |
| Gabapentin | Opioid Consumption, as Measured by Number of Tablets Taken. | Post-Operative Day 5, after noon | 1.07 Number of oxycodone 5mg tablets consumed | Standard Deviation 0.26 |
| Gabapentin | Opioid Consumption, as Measured by Number of Tablets Taken. | Post-Operative Day 7, after noon | 1 Number of oxycodone 5mg tablets consumed | Standard Deviation 0 |
| Gabapentin | Opioid Consumption, as Measured by Number of Tablets Taken. | Post-Operative Day 1, midnight | 1.14 Number of oxycodone 5mg tablets consumed | Standard Deviation 0.43 |
| Gabapentin | Opioid Consumption, as Measured by Number of Tablets Taken. | Post-Operative Day 6, before noon | 1.00 Number of oxycodone 5mg tablets consumed | Standard Deviation 0 |
| Gabapentin | Opioid Consumption, as Measured by Number of Tablets Taken. | Post-Operative Day 6, after noon | 1.00 Number of oxycodone 5mg tablets consumed | Standard Deviation 0 |
| Gabapentin | Opioid Consumption, as Measured by Number of Tablets Taken. | Post-Operative Day 7, before noon | 1 Number of oxycodone 5mg tablets consumed | Standard Deviation 0 |
| Placebo | Opioid Consumption, as Measured by Number of Tablets Taken. | Post-Operative Day 4, before noon | 1.10 Number of oxycodone 5mg tablets consumed | Standard Deviation 0.31 |
| Placebo | Opioid Consumption, as Measured by Number of Tablets Taken. | Post-Operative Day 0 | 1.54 Number of oxycodone 5mg tablets consumed | Standard Deviation 1.31 |
| Placebo | Opioid Consumption, as Measured by Number of Tablets Taken. | Post-Operative Day 6, before noon | 1.12 Number of oxycodone 5mg tablets consumed | Standard Deviation 0.33 |
| Placebo | Opioid Consumption, as Measured by Number of Tablets Taken. | Post-Operative Day 1, before noon | 1.38 Number of oxycodone 5mg tablets consumed | Standard Deviation 0.98 |
| Placebo | Opioid Consumption, as Measured by Number of Tablets Taken. | Post-Operative Day 4, after noon | 1.00 Number of oxycodone 5mg tablets consumed | Standard Deviation 0 |
| Placebo | Opioid Consumption, as Measured by Number of Tablets Taken. | Post-Operative Day 1, after noon | 1.27 Number of oxycodone 5mg tablets consumed | Standard Deviation 0.52 |
| Placebo | Opioid Consumption, as Measured by Number of Tablets Taken. | Post-Operative Day 1, midnight | 1.24 Number of oxycodone 5mg tablets consumed | Standard Deviation 0.74 |
| Placebo | Opioid Consumption, as Measured by Number of Tablets Taken. | Post-Operative Day 2, midnight | 1.23 Number of oxycodone 5mg tablets consumed | Standard Deviation 0.63 |
| Placebo | Opioid Consumption, as Measured by Number of Tablets Taken. | Post-Operative Day 5, before noon | 1.00 Number of oxycodone 5mg tablets consumed | Standard Deviation 0 |
| Placebo | Opioid Consumption, as Measured by Number of Tablets Taken. | Post-Operative Day 2, before noon | 1.48 Number of oxycodone 5mg tablets consumed | Standard Deviation 1.06 |
| Placebo | Opioid Consumption, as Measured by Number of Tablets Taken. | Post-Operative Day 5, after noon | 1.08 Number of oxycodone 5mg tablets consumed | Standard Deviation 0.28 |
| Placebo | Opioid Consumption, as Measured by Number of Tablets Taken. | Post-Operative Day 2, after noon | 1.52 Number of oxycodone 5mg tablets consumed | Standard Deviation 1.7 |
| Placebo | Opioid Consumption, as Measured by Number of Tablets Taken. | Post-Operative Day 7, before noon | 1.05 Number of oxycodone 5mg tablets consumed | Standard Deviation 0.21 |
| Placebo | Opioid Consumption, as Measured by Number of Tablets Taken. | Post-Operative Day 3, before noon | 1.2 Number of oxycodone 5mg tablets consumed | Standard Deviation 0.48 |
| Placebo | Opioid Consumption, as Measured by Number of Tablets Taken. | Post-Operative Day 6, after noon | 1.04 Number of oxycodone 5mg tablets consumed | Standard Deviation 0.2 |
| Placebo | Opioid Consumption, as Measured by Number of Tablets Taken. | Post-Operative Day 3, after noon | 1.11 Number of oxycodone 5mg tablets consumed | Standard Deviation 0.32 |
| Placebo | Opioid Consumption, as Measured by Number of Tablets Taken. | Post-Operative Day 7, after noon | 1.05 Number of oxycodone 5mg tablets consumed | Standard Deviation 0.22 |
Comparison: Mean number of opioid tablets taken at post-operative day 7 (compared between the two arms).p-value: 0.1995% CI: [-0.13, 0.03]t-test, 2 sided