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Difficult to enroll; since a similar research project on a different population showed no significance the study has been closed.
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Liposomal bupivacaine or placebo will be administered at the end of a transobturator midurethral sling to determine if there is a difference in a patient's perceived postoperative pain.
The investigators aim to evaluate the use of liposomal bupivacaine to reduce postoperative pain from placement of transobturator slings for the treatment of stress urinary incontinence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposomal bupivacaine | Active Comparator | Subjects in this arm will received the drug - liposomal bupivacaine 30 ml. |
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| Placebo | Placebo Comparator | Subjects in this arm will received the placebo - normal saline 30 mL. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | At the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure), those subjects in the placebo arm will have the 30ml of normal saline injected. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual analog scale (VAS) | To determine if liposomal bupivacaine administered at the completion of a transobturator suburethral sling will result in decreased postoperative pain compared to placebo. | 4 hours after being discharged home |
| Measure | Description | Time Frame |
|---|---|---|
| Likert scale to rate their level of satisfaction with their postoperative pain control. | To assess the amount of oral narcotic required for pain control following administration of liposomal bupivacaine or placebo at the completion of a transobturator sling procedure. | At 1 and 2 weeks postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| VAS to rate their level of satisfaction with their postoperative pain control. | To assess the amount of oral narcotic required for pain control following administration of liposomal bupivacaine or placebo at the completion of a transobturator sling procedure. | At 1 & 2 weeks postoperatively |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catrina C Crisp, MD | TriHealth Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TriHealth | Cincinnati | Ohio | 45220 | United States |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Liposomal bupivacaine | Drug | At the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure), those subjects in the placebo arm will have the 30ml of dilutional liposomal bupivacaine injected. |
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