Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Post-operative pain and lower urinary tract symptoms are common following ureteroscopy in the treatment of stone disease. The use of bupivacaine as a topical pain medication is used routinely for other urologic procedures, however, to date there are no studies that have rigorously investigated the effect of instilling bupivacaine in the bladder following ureteroscopy.
This is a randomized study that will investigate the effect of instilling bupivacaine in the bladder following routine ureteroscopy, laser lithotripsy and ureteral stenting in the treatment of stone disease. Compared to a placebo of Normal Saline, our study hypothesizes that administration of topical bupivacaine in the bladder will decrease post-operative pain and lower urinary tract symptoms while improving quality of life in the early post-operative period.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 50 ml of 0.25% bupivacaine | Experimental |
| |
| placebo of 50 ml of Normal Saline | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | The dose plan is to use 50 ml of 0.25% bupivacaine which corresponds with a total dose of 125mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative pain as determined by the score on a Visual Analog Scale (VAS) upon emergence from anesthesia | Pain will be assessed using a Likert 10-point scale upon emergence from anesthesia in the recovery room, post-emergence 30 minutes, 60 minutes post-emergence and 6 and 24 hours post-emergence. These types of scales are commonly used to measure post operative pain both in anesthesia and in endourology | At 30 minutes post-emergence, 60 minutes post-emergence, 6 hours post-emergence and on post-operative day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Milliequivalent of morphine consumed | From Baseline to post- operative day 5 | |
| Number of bladder spasms | From Baseline to post- operative day 5 | |
| Time to void |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luke Reynolds, MD | Contact | 7137926105 | lukereynolds@bsd.uchicago.edu | |
| Leila Yazdanbakhsh | Contact | leila.yazdanbakhsh@bsd.uchicago.edu |
| Name | Affiliation | Role |
|---|---|---|
| Luke Reynolds, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Chicago Medical Center | Recruiting | Chicago | Illinois | 60637 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Normal saline | Other | Placebo of 50 ml of Normal Saline |
|
| From Baseline to post- operative day 5 |
| Time to discharge | From Baseline to post- operative day 5 |
| Quality of life based on the Ureteral Stent Symptom Questionnaire (USSQ) | A validated tool of 38 questions that assesses the symptoms and quality of life impact of ureteral stents. | From Baseline to post- operative day 5 |
| The Patient-Reported Outcomes Measurement Information System (PROMIS) Adult Function Short Form | From Baseline to post- operative day 5 |
| Adverse events | From Baseline to post- operative day 5 |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D052801 | Male Urogenital Diseases |
| D000588 |
| Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |