Trial Outcomes & Findings for Gabapentin for Post-Operative Pain Control and Narcotic Reduction in Scrotal Surgery (NCT NCT04230980)

Last Updated: 2023-10-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

74 participants

Primary outcome timeframe

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

Results posted on

2023-10-18

Participant Flow

Participant milestones

Participant milestones
Measure	Gabapentin Participants receive Gabapentin 600mg tablet taken pre-operatively and 300mg taken three times a day for 3 days. Gabapentin: Gabapentin 600mg tablet	Placebo Participants receive Placebo tablet taken pre-operatively and three times a day for 3 days Placebo: Placebo tablet
Overall Study STARTED	36	38
Overall Study COMPLETED	35	35
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Gabapentin Participants receive Gabapentin 600mg tablet taken pre-operatively and 300mg taken three times a day for 3 days. Gabapentin: Gabapentin 600mg tablet	Placebo Participants receive Placebo tablet taken pre-operatively and three times a day for 3 days Placebo: Placebo tablet
Overall Study Lost to Follow-up	1	2
Overall Study Adverse Event	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gabapentin n=35 Participants Participants receive Gabapentin 600mg tablet taken pre-operatively and 300mg taken three times a day for 3 days. Gabapentin: Gabapentin 600mg tablet	Placebo n=35 Participants Participants receive Placebo tablet taken pre-operatively and three times a day for 3 days Placebo: Placebo tablet	Total n=70 Participants Total of all reporting groups
Age, Continuous	38 years STANDARD_DEVIATION 10.1 • n=5 Participants	34.9 years STANDARD_DEVIATION 7.1 • n=7 Participants	36.5 years STANDARD_DEVIATION 8.8 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants	35 Participants n=7 Participants	70 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants	26 Participants n=7 Participants	51 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	35 participants n=5 Participants	35 participants n=7 Participants	70 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Gabapentin n=35 Participants Participants receive Gabapentin 600mg tablet taken pre-operatively and 300mg taken three times a day for 3 days. Gabapentin: Gabapentin 600mg tablet	Placebo n=35 Participants Participants receive Placebo tablet taken pre-operatively and three times a day for 3 days Placebo: Placebo tablet
Pain Score as Measured by the NRS-11 Scale Post-Operative Day 0	1.91 scores on a scale Standard Deviation 1.63	3.05 scores on a scale Standard Deviation 2.68
Pain Score as Measured by the NRS-11 Scale Post-Operative Day 1, midnight	2.27 scores on a scale Standard Deviation 1.55	3.24 scores on a scale Standard Deviation 2.7
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	3.33 scores on a scale Standard Deviation 2.75
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	3.65 scores on a scale Standard Deviation 2.6
Pain Score as Measured by the NRS-11 Scale Post-Operative Day 2, midnight	2.19 scores on a scale Standard Deviation 1.86	3.83 scores on a scale Standard Deviation 2.58
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	3.77 scores on a scale Standard Deviation 2.94
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	3.5 scores on a scale Standard Deviation 2.52
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	3.16 scores on a scale Standard Deviation 2.39
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	2.98 scores on a scale Standard Deviation 2.39
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	2.44 scores on a scale Standard Deviation 2.02
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	2.93 scores on a scale Standard Deviation 2.58
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	2.54 scores on a scale Standard Deviation 1.88
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	2.79 scores on a scale Standard Deviation 2.14
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	2.26 scores on a scale Standard Deviation 2.11
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	2.50 scores on a scale Standard Deviation 2.19
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	2.25 scores on a scale Standard Deviation 2.14
Pain Score as Measured by the NRS-11 Scale Post-Operative Day 7, after noon	.99 scores on a scale Standard Deviation 1.4	2.12 scores on a scale Standard Deviation 2.24

SECONDARY outcome

Timeframe: 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.

Outcome measures

SECONDARY outcome

Timeframe: 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.

Frequency of narcotic tablets that were taken after surgery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome data not reported

Adverse Events

Gabapentin

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Gabapentin n=36 participants at risk Participants receive Gabapentin 600mg tablet taken pre-operatively and 300mg taken three times a day for 3 days. Gabapentin: Gabapentin 600mg tablet	Placebo n=38 participants at risk Participants receive Placebo tablet taken pre-operatively and three times a day for 3 days Placebo: Placebo tablet
General disorders syncopal episode	0.00% 0/36 • After surgery (post-operative day 0) through 2 weeks post-operatively. Adverse events were self-reported by participants from the day of surgery (post-operative day 0) through post-operative day 7, along with pain score and number of opioid tablets taken. Participants were also evaluated and assessed for adverse events 2-weeks post-operatively by the surgeon.	5.3% 2/38 • Number of events 2 • After surgery (post-operative day 0) through 2 weeks post-operatively. Adverse events were self-reported by participants from the day of surgery (post-operative day 0) through post-operative day 7, along with pain score and number of opioid tablets taken. Participants were also evaluated and assessed for adverse events 2-weeks post-operatively by the surgeon.

Other adverse events

Additional Information

Grace Tan, Clinical Research Coordinator

Weill Cornell Medical College

Phone: 212-746-3208

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Gabapentin n=35 Participants Participants receive Gabapentin 600mg tablet taken pre-operatively and 300mg taken three times a day for 3 days. Gabapentin: Gabapentin 600mg tablet	Placebo n=35 Participants Participants receive Placebo tablet taken pre-operatively and three times a day for 3 days Placebo: Placebo tablet
Opioid Consumption, as Measured by Number of Tablets Taken. Post-Operative Day 0	1.11 Number of oxycodone 5mg tablets consumed Standard Deviation .32	1.54 Number of oxycodone 5mg tablets consumed Standard Deviation 1.31
Opioid Consumption, as Measured by Number of Tablets Taken. Post-Operative Day 1, midnight	1.14 Number of oxycodone 5mg tablets consumed Standard Deviation .43	1.24 Number of oxycodone 5mg tablets consumed Standard Deviation .74
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 .47	1.38 Number of oxycodone 5mg tablets consumed Standard Deviation .98
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 .36	1.27 Number of oxycodone 5mg tablets consumed Standard Deviation .52
Opioid Consumption, as Measured by Number of Tablets Taken. Post-Operative Day 2, midnight	1.18 Number of oxycodone 5mg tablets consumed Standard Deviation .39	1.23 Number of oxycodone 5mg tablets consumed Standard Deviation .63
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 .52	1.48 Number of oxycodone 5mg tablets consumed Standard Deviation 1.06
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 .33	1.52 Number of oxycodone 5mg tablets consumed Standard Deviation 1.7
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 .29	1.2 Number of oxycodone 5mg tablets consumed Standard Deviation .48
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	1.11 Number of oxycodone 5mg tablets consumed Standard Deviation 0.32
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	1.10 Number of oxycodone 5mg tablets consumed Standard Deviation 0.31
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	1.00 Number of oxycodone 5mg tablets consumed Standard Deviation 0.00
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 0.00	1.00 Number of oxycodone 5mg tablets consumed Standard Deviation 0.00
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	1.08 Number of oxycodone 5mg tablets consumed Standard Deviation 0.28
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 0.00	1.12 Number of oxycodone 5mg tablets consumed Standard Deviation 0.33
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 0.00	1.04 Number of oxycodone 5mg tablets consumed Standard Deviation 0.20
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	1.05 Number of oxycodone 5mg tablets consumed Standard Deviation .21
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	1.05 Number of oxycodone 5mg tablets consumed Standard Deviation .22

Measure	Gabapentin n=36 participants at risk Participants receive Gabapentin 600mg tablet taken pre-operatively and 300mg taken three times a day for 3 days. Gabapentin: Gabapentin 600mg tablet	Placebo n=38 participants at risk Participants receive Placebo tablet taken pre-operatively and three times a day for 3 days Placebo: Placebo tablet
Gastrointestinal disorders GI upset (abdominal pain, bloating, heartburn)	11.1% 4/36 • Number of events 4 • After surgery (post-operative day 0) through 2 weeks post-operatively. Adverse events were self-reported by participants from the day of surgery (post-operative day 0) through post-operative day 7, along with pain score and number of opioid tablets taken. Participants were also evaluated and assessed for adverse events 2-weeks post-operatively by the surgeon.	23.7% 9/38 • Number of events 9 • After surgery (post-operative day 0) through 2 weeks post-operatively. Adverse events were self-reported by participants from the day of surgery (post-operative day 0) through post-operative day 7, along with pain score and number of opioid tablets taken. Participants were also evaluated and assessed for adverse events 2-weeks post-operatively by the surgeon.
Gastrointestinal disorders Constipation	5.6% 2/36 • Number of events 2 • After surgery (post-operative day 0) through 2 weeks post-operatively. Adverse events were self-reported by participants from the day of surgery (post-operative day 0) through post-operative day 7, along with pain score and number of opioid tablets taken. Participants were also evaluated and assessed for adverse events 2-weeks post-operatively by the surgeon.	7.9% 3/38 • Number of events 3 • After surgery (post-operative day 0) through 2 weeks post-operatively. Adverse events were self-reported by participants from the day of surgery (post-operative day 0) through post-operative day 7, along with pain score and number of opioid tablets taken. Participants were also evaluated and assessed for adverse events 2-weeks post-operatively by the surgeon.
Gastrointestinal disorders Nausea	5.6% 2/36 • Number of events 2 • After surgery (post-operative day 0) through 2 weeks post-operatively. Adverse events were self-reported by participants from the day of surgery (post-operative day 0) through post-operative day 7, along with pain score and number of opioid tablets taken. Participants were also evaluated and assessed for adverse events 2-weeks post-operatively by the surgeon.	2.6% 1/38 • Number of events 1 • After surgery (post-operative day 0) through 2 weeks post-operatively. Adverse events were self-reported by participants from the day of surgery (post-operative day 0) through post-operative day 7, along with pain score and number of opioid tablets taken. Participants were also evaluated and assessed for adverse events 2-weeks post-operatively by the surgeon.
Nervous system disorders Paresthesia	13.9% 5/36 • Number of events 5 • After surgery (post-operative day 0) through 2 weeks post-operatively. Adverse events were self-reported by participants from the day of surgery (post-operative day 0) through post-operative day 7, along with pain score and number of opioid tablets taken. Participants were also evaluated and assessed for adverse events 2-weeks post-operatively by the surgeon.	7.9% 3/38 • Number of events 3 • After surgery (post-operative day 0) through 2 weeks post-operatively. Adverse events were self-reported by participants from the day of surgery (post-operative day 0) through post-operative day 7, along with pain score and number of opioid tablets taken. Participants were also evaluated and assessed for adverse events 2-weeks post-operatively by the surgeon.
Nervous system disorders Blurry vision	2.8% 1/36 • Number of events 1 • After surgery (post-operative day 0) through 2 weeks post-operatively. Adverse events were self-reported by participants from the day of surgery (post-operative day 0) through post-operative day 7, along with pain score and number of opioid tablets taken. Participants were also evaluated and assessed for adverse events 2-weeks post-operatively by the surgeon.	0.00% 0/38 • After surgery (post-operative day 0) through 2 weeks post-operatively. Adverse events were self-reported by participants from the day of surgery (post-operative day 0) through post-operative day 7, along with pain score and number of opioid tablets taken. Participants were also evaluated and assessed for adverse events 2-weeks post-operatively by the surgeon.
Nervous system disorders Headache	2.8% 1/36 • Number of events 1 • After surgery (post-operative day 0) through 2 weeks post-operatively. Adverse events were self-reported by participants from the day of surgery (post-operative day 0) through post-operative day 7, along with pain score and number of opioid tablets taken. Participants were also evaluated and assessed for adverse events 2-weeks post-operatively by the surgeon.	5.3% 2/38 • Number of events 2 • After surgery (post-operative day 0) through 2 weeks post-operatively. Adverse events were self-reported by participants from the day of surgery (post-operative day 0) through post-operative day 7, along with pain score and number of opioid tablets taken. Participants were also evaluated and assessed for adverse events 2-weeks post-operatively by the surgeon.
General disorders Dizziness	13.9% 5/36 • Number of events 5 • After surgery (post-operative day 0) through 2 weeks post-operatively. Adverse events were self-reported by participants from the day of surgery (post-operative day 0) through post-operative day 7, along with pain score and number of opioid tablets taken. Participants were also evaluated and assessed for adverse events 2-weeks post-operatively by the surgeon.	2.6% 1/38 • Number of events 1 • After surgery (post-operative day 0) through 2 weeks post-operatively. Adverse events were self-reported by participants from the day of surgery (post-operative day 0) through post-operative day 7, along with pain score and number of opioid tablets taken. Participants were also evaluated and assessed for adverse events 2-weeks post-operatively by the surgeon.
General disorders Lightheadedness	2.8% 1/36 • Number of events 1 • After surgery (post-operative day 0) through 2 weeks post-operatively. Adverse events were self-reported by participants from the day of surgery (post-operative day 0) through post-operative day 7, along with pain score and number of opioid tablets taken. Participants were also evaluated and assessed for adverse events 2-weeks post-operatively by the surgeon.	7.9% 3/38 • Number of events 3 • After surgery (post-operative day 0) through 2 weeks post-operatively. Adverse events were self-reported by participants from the day of surgery (post-operative day 0) through post-operative day 7, along with pain score and number of opioid tablets taken. Participants were also evaluated and assessed for adverse events 2-weeks post-operatively by the surgeon.
General disorders Somnolence, drowsiness	11.1% 4/36 • Number of events 4 • After surgery (post-operative day 0) through 2 weeks post-operatively. Adverse events were self-reported by participants from the day of surgery (post-operative day 0) through post-operative day 7, along with pain score and number of opioid tablets taken. Participants were also evaluated and assessed for adverse events 2-weeks post-operatively by the surgeon.	2.6% 1/38 • Number of events 1 • After surgery (post-operative day 0) through 2 weeks post-operatively. Adverse events were self-reported by participants from the day of surgery (post-operative day 0) through post-operative day 7, along with pain score and number of opioid tablets taken. Participants were also evaluated and assessed for adverse events 2-weeks post-operatively by the surgeon.
General disorders Fatigue	2.8% 1/36 • Number of events 1 • After surgery (post-operative day 0) through 2 weeks post-operatively. Adverse events were self-reported by participants from the day of surgery (post-operative day 0) through post-operative day 7, along with pain score and number of opioid tablets taken. Participants were also evaluated and assessed for adverse events 2-weeks post-operatively by the surgeon.	2.6% 1/38 • Number of events 1 • After surgery (post-operative day 0) through 2 weeks post-operatively. Adverse events were self-reported by participants from the day of surgery (post-operative day 0) through post-operative day 7, along with pain score and number of opioid tablets taken. Participants were also evaluated and assessed for adverse events 2-weeks post-operatively by the surgeon.
General disorders Insomnia	2.8% 1/36 • Number of events 1 • After surgery (post-operative day 0) through 2 weeks post-operatively. Adverse events were self-reported by participants from the day of surgery (post-operative day 0) through post-operative day 7, along with pain score and number of opioid tablets taken. Participants were also evaluated and assessed for adverse events 2-weeks post-operatively by the surgeon.	2.6% 1/38 • Number of events 1 • After surgery (post-operative day 0) through 2 weeks post-operatively. Adverse events were self-reported by participants from the day of surgery (post-operative day 0) through post-operative day 7, along with pain score and number of opioid tablets taken. Participants were also evaluated and assessed for adverse events 2-weeks post-operatively by the surgeon.
General disorders Hot flashes	0.00% 0/36 • After surgery (post-operative day 0) through 2 weeks post-operatively. Adverse events were self-reported by participants from the day of surgery (post-operative day 0) through post-operative day 7, along with pain score and number of opioid tablets taken. Participants were also evaluated and assessed for adverse events 2-weeks post-operatively by the surgeon.	2.6% 1/38 • Number of events 1 • After surgery (post-operative day 0) through 2 weeks post-operatively. Adverse events were self-reported by participants from the day of surgery (post-operative day 0) through post-operative day 7, along with pain score and number of opioid tablets taken. Participants were also evaluated and assessed for adverse events 2-weeks post-operatively by the surgeon.
Musculoskeletal and connective tissue disorders Weakness	5.6% 2/36 • Number of events 2 • After surgery (post-operative day 0) through 2 weeks post-operatively. Adverse events were self-reported by participants from the day of surgery (post-operative day 0) through post-operative day 7, along with pain score and number of opioid tablets taken. Participants were also evaluated and assessed for adverse events 2-weeks post-operatively by the surgeon.	0.00% 0/38 • After surgery (post-operative day 0) through 2 weeks post-operatively. Adverse events were self-reported by participants from the day of surgery (post-operative day 0) through post-operative day 7, along with pain score and number of opioid tablets taken. Participants were also evaluated and assessed for adverse events 2-weeks post-operatively by the surgeon.
Musculoskeletal and connective tissue disorders Muscle stiffness	0.00% 0/36 • After surgery (post-operative day 0) through 2 weeks post-operatively. Adverse events were self-reported by participants from the day of surgery (post-operative day 0) through post-operative day 7, along with pain score and number of opioid tablets taken. Participants were also evaluated and assessed for adverse events 2-weeks post-operatively by the surgeon.	2.6% 1/38 • Number of events 1 • After surgery (post-operative day 0) through 2 weeks post-operatively. Adverse events were self-reported by participants from the day of surgery (post-operative day 0) through post-operative day 7, along with pain score and number of opioid tablets taken. Participants were also evaluated and assessed for adverse events 2-weeks post-operatively by the surgeon.
Respiratory, thoracic and mediastinal disorders Chest tightness	2.8% 1/36 • Number of events 1 • After surgery (post-operative day 0) through 2 weeks post-operatively. Adverse events were self-reported by participants from the day of surgery (post-operative day 0) through post-operative day 7, along with pain score and number of opioid tablets taken. Participants were also evaluated and assessed for adverse events 2-weeks post-operatively by the surgeon.	0.00% 0/38 • After surgery (post-operative day 0) through 2 weeks post-operatively. Adverse events were self-reported by participants from the day of surgery (post-operative day 0) through post-operative day 7, along with pain score and number of opioid tablets taken. Participants were also evaluated and assessed for adverse events 2-weeks post-operatively by the surgeon.