Trial Outcomes & Findings for Efficacy of Opioid-limiting Pain Management Protocol in Men Undergoing Urethroplasty (NCT NCT03859024)

Last Updated: 2024-09-19

Results Overview

Self-report via pain score on the Numerical Rating Scale (NRS) for pain, an 11-point scale for patient self-reporting of pain. A rating of 0 equates to no pain, 1-3 equates to mild pain, 4-6 equates to moderate pain, and 7-10 equates to severe pain. Assessment will occur at clinic visit, at pre-op visit, in pre-op holding before surgery, per anesthesia protocol after surgery in recovery and discharge unit, and at postoperative visit

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

48 participants

Primary outcome timeframe

3 weeks

Results posted on

2024-09-19

Participant Flow

Participant milestones

Participant milestones
Measure	Standard Protocol Patients will receive the historical standard for pain management, which may include narcotics during and after surgery. Postoperative prescriptions ibuprofen 800 mg, and acetaminophen 1000 mg to be taken on a scheduled basis then as needed. Another prescription for oxycodone will be given to be used only if needed. Oxycodone: oxycodone tablet Acetaminophen: acetaminophen tablet Ibuprofen 800 mg: ibuprofen tablet	Enhanced Recovery Protocol A combination regimen of acetaminophen, Celebrex and gabapentin pre-op, with 30 mL of 0.5% bupivacaine and 4 mg of dexamethasone given as a perineal nerve block at the time of urethroplasty surgery. Narcotics will be administered judiciously and ass seen fit by the anesthesia and/or surgical teams. Postoperative prescriptions ibuprofen 800 mg, and acetaminophen 1000 mg to be taken on a scheduled basis then as needed. Another prescription for oxycodone will be given to be used only if needed. Oxycodone: oxycodone tablet Acetaminophen: acetaminophen tablet Gabapentin: gabapentin tablet celebrex: Celebrex tablet Bupivacaine: bupivacaine injection Ibuprofen 800 mg: ibuprofen tablet Dexamethasone: Dexamethasone injection
Overall Study STARTED	23	25
Overall Study COMPLETED	23	24
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Protocol n=23 Participants Patients will receive the historical standard for pain management, which may include narcotics during and after surgery. Postoperative prescriptions ibuprofen 800 mg, and acetaminophen 1000 mg to be taken on a scheduled basis then as needed. Another prescription for oxycodone will be given to be used only if needed. Oxycodone: oxycodone tablet Acetaminophen: acetaminophen tablet Ibuprofen 800 mg: ibuprofen tablet	Enhanced Recovery Protocol n=25 Participants A combination regimen of acetaminophen, Celebrex and gabapentin pre-op, with 30 mL of 0.5% bupivacaine and 4 mg of dexamethasone given as a perineal nerve block at the time of urethroplasty surgery. Narcotics will be administered judiciously and ass seen fit by the anesthesia and/or surgical teams. Postoperative prescriptions ibuprofen 800 mg, and acetaminophen 1000 mg to be taken on a scheduled basis then as needed. Another prescription for oxycodone will be given to be used only if needed. Oxycodone: oxycodone tablet Acetaminophen: acetaminophen tablet Gabapentin: gabapentin tablet celebrex: Celebrex tablet Bupivacaine: bupivacaine injection Ibuprofen 800 mg: ibuprofen tablet Dexamethasone: Dexamethasone injection	Total n=48 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=23 Participants	0 Participants n=25 Participants	0 Participants n=48 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=23 Participants	21 Participants n=25 Participants	41 Participants n=48 Participants
Age, Categorical >=65 years	3 Participants n=23 Participants	4 Participants n=25 Participants	7 Participants n=48 Participants
Age, Continuous	50 years n=23 Participants	50 years n=25 Participants	50 years n=48 Participants
Sex: Female, Male Female	0 Participants n=23 Participants	0 Participants n=25 Participants	0 Participants n=48 Participants
Sex: Female, Male Male	23 Participants n=23 Participants	25 Participants n=25 Participants	48 Participants n=48 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	23 participants n=23 Participants	25 participants n=25 Participants	48 participants n=48 Participants

PRIMARY outcome

Timeframe: 3 weeks

Outcome measures

Outcome measures
Measure	Standard Protocol n=23 Participants Patients will receive the historical standard for pain management, which may include narcotics during and after surgery. Postoperative prescriptions ibuprofen 800 mg, and acetaminophen 1000 mg to be taken on a scheduled basis then as needed. Another prescription for oxycodone will be given to be used only if needed. Oxycodone: oxycodone tablet Acetaminophen: acetaminophen tablet Ibuprofen 800 mg: ibuprofen tablet	Enhanced Recovery Protocol n=24 Participants A combination regimen of acetaminophen, Celebrex and gabapentin pre-op, with 30 mL of 0.5% bupivacaine and 4 mg of dexamethasone given as a perineal nerve block at the time of urethroplasty surgery. Narcotics will be administered judiciously and ass seen fit by the anesthesia and/or surgical teams. Postoperative prescriptions ibuprofen 800 mg, and acetaminophen 1000 mg to be taken on a scheduled basis then as needed. Another prescription for oxycodone will be given to be used only if needed. Oxycodone: oxycodone tablet Acetaminophen: acetaminophen tablet Gabapentin: gabapentin tablet celebrex: Celebrex tablet Bupivacaine: bupivacaine injection Ibuprofen 800 mg: ibuprofen tablet Dexamethasone: Dexamethasone injection
Participant Pain Control: Numerical Rating Scale (NRS)	1.2 score on a scale Interval 0.0 to 10.0	.625 score on a scale Interval 0.0 to 10.0

PRIMARY outcome

Timeframe: 3 weeks

Amount of opioid medication used, based on return pill count at postoperative visit.

Outcome measures

Outcome measures
Measure	Standard Protocol n=23 Participants Patients will receive the historical standard for pain management, which may include narcotics during and after surgery. Postoperative prescriptions ibuprofen 800 mg, and acetaminophen 1000 mg to be taken on a scheduled basis then as needed. Another prescription for oxycodone will be given to be used only if needed. Oxycodone: oxycodone tablet Acetaminophen: acetaminophen tablet Ibuprofen 800 mg: ibuprofen tablet	Enhanced Recovery Protocol n=24 Participants A combination regimen of acetaminophen, Celebrex and gabapentin pre-op, with 30 mL of 0.5% bupivacaine and 4 mg of dexamethasone given as a perineal nerve block at the time of urethroplasty surgery. Narcotics will be administered judiciously and ass seen fit by the anesthesia and/or surgical teams. Postoperative prescriptions ibuprofen 800 mg, and acetaminophen 1000 mg to be taken on a scheduled basis then as needed. Another prescription for oxycodone will be given to be used only if needed. Oxycodone: oxycodone tablet Acetaminophen: acetaminophen tablet Gabapentin: gabapentin tablet celebrex: Celebrex tablet Bupivacaine: bupivacaine injection Ibuprofen 800 mg: ibuprofen tablet Dexamethasone: Dexamethasone injection
Opioid Medication Use	5.14 pill count Interval 0.0 to 14.0	4.96 pill count Interval 0.0 to 14.0

Adverse Events

Standard Protocol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Enhanced Recovery Protocol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Adam Baumgarten

University of Alabama at Birmingham

Phone: 205-996-6769

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place