Pain, PostoperativePhase 4NCT03859024
Efficacy of Opioid-limiting Pain Management Protocol in Men Undergoing Urethroplasty
A Phase 4 study testing Oxycodone, Acetaminophen and Gabapentin in people with Pain, Postoperative and Urethral Stricture, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The investigator's study aims to see if an enhanced recovery regimen of pain medications before and during surgery will decrease the use and risk of opioid pain medications as well as improve pain control in anterior urethroplasty patients. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Pain, Postoperative, Urethral Stricture
- What is being tested?
- Oxycodone, Acetaminophen and Gabapentin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2019to 30 Jun 2023
- Phase
- Phase 4
- 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
- Men greater than 18 years of age who are scheduled for anterior urethroplasty surgery
Who cannot join
- Any patient not classified as a II or III on the American Society of Anesthesiologists (ASA) physical status classification system.
- General anesthesia or neuraxial anesthesia with epidural used as anesthetic techniques
- Allergy/intolerance to local anesthetic or steroids
- Pre-existing neurological and/or anatomical deficit that would preclude regional block
- Coexisting coagulopathy such as hemophilia or von Willebrand Disease
- BMI greater than 40 or less then 20
Show all 15Show fewer
- History of intravenous drug or opioid abuse
- History of opioid use within a week prior to urethroplasty
- History of any chronic pain syndrome
- Posterior urethroplasty
- Patients with chronic kidney disease
- Patients allergic to NSAIDs
- Patients requiring more than one buccal graft harvest
- Patients with graft urethroplasty with site other than buccal
- Patients with a history of previous urethroplasty
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama of Birmingham
Birmingham, Alabama, 35233
About this study
The investigator's study aims to see if an enhanced recovery regimen of pain medications before and during surgery will decrease the use and risk of opioid pain medications as well as improve pain control in anterior urethroplasty patients. Participants will be randomized to one of two pain regimens (enhanced recovery regimen vs standard regimen).
Read the detailed description
The purpose of this study is to assess the difference in narcotics usage between two different pain management protocols after urethroplasty. Management at the current time varies between giving intraoperative painkillers along with peripheral nerve blocks in some patients, while others do not receive this protocol. In this study, one group will continue the historical standard of care of the hospital, receiving postoperative nonsteroidal anti-inflammatory drugs (NSAIDs) and narcotics for pain control. The other group will utilize a protocol to lower narcotics usage, including acetaminophen, gabapentin, Celebrex, and local anesthetic (bupivacaine) in an attempt to reduce the usage of narcotics postoperatively. Given the heightened concern over narcotic usage by postoperative patients, including the risk of chronic usage by even young patients, the objective will be to assess if using this protocol as a new standard can limit the need for postoperative narcotics prescriptions.
In related urological procedures, bupivacaine injections given before surgeries have been shown to significantly lower pain scores after surgery for patients undergoing penile prosthesis. The University of Alabama at Birmingham has also been using an Enhanced Recovery After Surgery (ERAS) protocol, a multimodal presurgical care pathway designed to achieve early recovery after surgical procedures, for cystectomy and seen reduced narcotic usage among those patients.
This study would potentially help determine a new pain management protocol for urology patients undergoing anterior urethroplasty that is both more effective and less risky.
- Conditions
- Pain, Postoperative, Urethral Stricture
- Being tested
- Oxycodone, Acetaminophen, Gabapentin, celebrex, Bupivacaine
- Keywords
- anterior urethroplasty, pain management, postoperative pain, opioid use
- Medical subject headings
- Pain, Postoperative, Urethral Stricture, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxycodoneDrug
Also called oxycontin
oxycodone tablet
AcetaminophenDrug
Also called tylenol
acetaminophen tablet
GabapentinDrug
Also called neurontin
gabapentin tablet
celebrexDrug
Also called celecoxib
Celebrex tablet
BupivacaineDrug
Also called marcaine, exparel
bupivacaine injection
Ibuprofen 800 mgDrug
Also called advil, motrin
ibuprofen tablet
DexamethasoneDrug
Also called decadron, ozurdex
Dexamethasone injection
| Study group | Role | What they receive |
|---|---|---|
| Standard Protocol | Active comparator | 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. Receives: Drug: Oxycodone; Drug: Acetaminophen; Drug: Ibuprofen 800 mg |
| Enhanced Recovery Protocol | Experimental | 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. Receives: Drug: Oxycodone; Drug: Acetaminophen; Drug: Gabapentin; Drug: celebrex; Drug: Bupivacaine; Drug: Ibuprofen 800 mg; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Pain Control: Numerical Rating Scale (NRS)
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
Measured: 3 weeks
Opioid Medication Use
Amount of opioid medication used, based on return pill count at postoperative visit.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start22 Mar 2019
- Primary completion30 Apr 2023
- Study completion30 Jun 2023
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.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Baumgarten, University of Alabama at Birmingham
- Investigators
- John P Selph, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03859024
- Sponsor's protocol ID
- IRB-300002992
- Status last verified
- Aug 2024
- First submitted
- 27 Feb 2019
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Opioid-limiting Pain Management Protocol in Men Undergoing Urethroplasty
- ClinicalTrials.gov ID
- NCT03859024
- Acronym / sponsor ID
- IRB-300002992
- Conditions
- Pain, Postoperative, Urethral Stricture
- Keywords
- anterior urethroplasty, pain management, postoperative pain, opioid use
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 22 Mar 2019 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 1 Mar 2019 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigator's study aims to see if an enhanced recovery regimen of pain medications before and during surgery will decrease the use and risk of opioid pain medications as well as improve pain control in anterior urethroplasty patients. Participants will be randomized to one of two pain regimens (enhanced recovery regimen vs standard regimen).
Detailed description
The purpose of this study is to assess the difference in narcotics usage between two different pain management protocols after urethroplasty. Management at the current time varies between giving intraoperative painkillers along with peripheral nerve blocks in some patients, while others do not receive this protocol. In this study, one group will continue the historical standard of care of the hospital, receiving postoperative nonsteroidal anti-inflammatory drugs (NSAIDs) and narcotics for pain control. The other group will utilize a protocol to lower narcotics usage, including acetaminophen, gabapentin, Celebrex, and local anesthetic (bupivacaine) in an attempt to reduce the usage of narcotics postoperatively. Given the heightened concern over narcotic usage by postoperative patients, including the risk of chronic usage by even young patients, the objective will be to assess if using this protocol as a new standard can limit the need for postoperative narcotics prescriptions.
In related urological procedures, bupivacaine injections given before surgeries have been shown to significantly lower pain scores after surgery for patients undergoing penile prosthesis. The University of Alabama at Birmingham has also been using an Enhanced Recovery After Surgery (ERAS) protocol, a multimodal presurgical care pathway designed to achieve early recovery after surgical procedures, for cystectomy and seen reduced narcotic usage among those patients.
This study would potentially help determine a new pain management protocol for urology patients undergoing anterior urethroplasty that is both more effective and less risky.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Protocol | Active comparator | Drug: Oxycodone, Drug: Acetaminophen, Drug: Ibuprofen 800 mgPatients 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. |
| Enhanced Recovery Protocol | Experimental | Drug: Oxycodone, Drug: Acetaminophen, Drug: Gabapentin, Drug: celebrex, Drug: Bupivacaine, Drug: Ibuprofen 800 mg, Drug: DexamethasoneA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men greater than 18 years of age who are scheduled for anterior urethroplasty surgery
Key exclusion criteria (15 listed)
- Any patient not classified as a II or III on the American Society of Anesthesiologists (ASA) physical status classification system.
- General anesthesia or neuraxial anesthesia with epidural used as anesthetic techniques
- Allergy/intolerance to local anesthetic or steroids
- Pre-existing neurological and/or anatomical deficit that would preclude regional block
- Coexisting coagulopathy such as hemophilia or von Willebrand Disease
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 |
|---|---|---|
| OxycodoneAlso: oxycontinoxycodone tablet | Drug | Enhanced Recovery Protocol, Standard Protocol |
| AcetaminophenAlso: tylenolacetaminophen tablet | Drug | Enhanced Recovery Protocol, Standard Protocol |
| GabapentinAlso: neurontingabapentin tablet | Drug | Enhanced Recovery Protocol |
| celebrexAlso: celecoxibCelebrex tablet | Drug | Enhanced Recovery Protocol |
| BupivacaineAlso: marcaine, exparelbupivacaine injection | Drug | Enhanced Recovery Protocol |
| Ibuprofen 800 mgAlso: advil, motrinibuprofen tablet | Drug | Enhanced Recovery Protocol, Standard Protocol |
| DexamethasoneAlso: decadron, ozurdexDexamethasone injection | Drug | Enhanced Recovery Protocol |
Primary outcome
Participant Pain Control: Numerical Rating Scale (NRS)
Time frame: 3 weeks
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
Opioid Medication Use
Time frame: 3 weeks
Amount of opioid medication used, based on return pill count at postoperative visit.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
John P Selph, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxycodone, Acetaminophen and Gabapentin in people with Pain, Postoperative and Urethral Stricture, run by University of Alabama at Birmingham 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 1 inclusion and 15 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 19 Sep 2024. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 19 Sep 2024). 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?
Participant Pain Control: Numerical Rating Scale (NRS) (time frame: 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024; AzTrials last refreshed its copy on 7 Nov 2026.