University of Alabama of Birmingham
Birmingham, Alabama, 35233, United States
NCT Number: NCT03859024
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).
Looking for future studies?
Notify Me18 year and older
Male
Interventional
Phase 4
Birmingham, Alabama, 35233, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
oxycodone tablet
Other names: oxycontin
acetaminophen tablet
Other names: tylenol
gabapentin tablet
Other names: neurontin
Celebrex tablet
Other names: celecoxib
bupivacaine injection
Other names: marcaine, exparel
ibuprofen tablet
Other names: advil, motrin
Dexamethasone injection
Other names: decadron, ozurdex
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
Time frame: 3 weeks
Amount of opioid medication used, based on return pill count at postoperative visit.
University of Alabama at Birmingham
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07165041
Agnosia, Nervous System Diseases
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT06282666
Acute Pain, Agnosia
Lublin, Poland
View Trial DetailsNCT04624880
Agnosia, Disease Attributes
Palo Alto, California, United States
View Trial DetailsNCT06217263
Agnosia, Chest Tubes
Istanbul, Turkey (Türkiye)
View Trial Details