Pain, Postoperative, Urethral Stricture
Conditions
Keywords
anterior urethroplasty, pain management, postoperative pain, opioid use
Brief 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. 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.
Interventions
DRUGOxycodone
oxycodone tablet
DRUGAcetaminophen
acetaminophen tablet
DRUGGabapentin
gabapentin tablet
DRUGcelebrex
Celebrex tablet
DRUGBupivacaine
bupivacaine injection
DRUGIbuprofen 800 mg
ibuprofen tablet
DRUGDexamethasone
Dexamethasone injection
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men greater than 18 years of age who are scheduled for anterior urethroplasty surgery
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant Pain Control: Numerical Rating Scale (NRS) | 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 | 3 weeks | Amount of opioid medication used, based on return pill count at postoperative visit. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 23 |
| 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 | 25 |
| Total | 48 |
Baseline characteristics
| Characteristic | Enhanced Recovery Protocol | Total | Standard Protocol |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 7 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 41 Participants | 20 Participants |
| Age, Continuous | 50 years | 50 years | 50 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 25 participants | 48 participants | 23 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 25 Participants | 48 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 25 |
| other Total, other adverse events | 0 / 23 | 0 / 25 |
| serious Total, serious adverse events | 0 / 23 | 0 / 25 |
Outcome results
Primary
Opioid Medication Use
Amount of opioid medication used, based on return pill count at postoperative visit.
Time frame: 3 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Protocol | Opioid Medication Use | 5.14 pill count |
| Enhanced Recovery Protocol | Opioid Medication Use | 4.96 pill count |
Primary
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
Time frame: 3 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Protocol | Participant Pain Control: Numerical Rating Scale (NRS) | 1.2 score on a scale |
| Enhanced Recovery Protocol | Participant Pain Control: Numerical Rating Scale (NRS) | .625 score on a scale |