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Postoperative pain, the quality of their recovery and the opioid consumption following a midurethral sling placement are being compared between 2 groups. One group will have the hydro-dissection performed with a diluted liposomal bupivacaine solution. The other group will have the hydro-dissection performed with a diluted bupivacaine HCL and Lidocaine solution.
This is a prospective, comparative, randomized study. Women with pure stress urinary incontinence or mixed urinary incontinence with a predominant stress component who had chosen to proceed with a midurethral sling will be randomized to two groups. The study group will have the hydro-dissection performed with a diluted liposomal bupivacaine solution. The comparison group would have the hydro-dissection performed with a diluted bupivacaine HCL and Lidocaine solution. The postoperative pain will be compared between groups using a visual analog scale. The quality of recovery will be compared between the groups using the quality of recovery short form. Postoperative opioid consumption will be compared between the two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposomal Bupivacaine | Experimental | 20mL of Liposomal Bupivacaine (EXPAREL) will be diluted in 80 mL of injectable saline used for hydro-dissection of the vesicovaginal space and along the track of the sling trocars during the placement of a suburethral sling. |
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| Bupivacaine Hydrochloride and Lidocaine | Active Comparator | Bupivacaine Hydrochloride (HCL) and Lidocaine. Fifty mL of 0.05% Marcaine and 30 mL of Lidocaine will be diluted in 100 mL of injectable saline used for hydro-dissection of the vesicovaginal space and along the track of the sling trocars during the placement of a suburethral sling. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal Bupivacaine | Drug | 20 mL of Liposomal Bupivacaine (EXPAREL) will be diluted in 80 mL of injectable saline used for hydro-dissection of the vesicovaginal space and along the track of the sling trocars |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Day 1 Pain | Average pain rating experienced on postoperative day one using the visual analog scale (VAS) on scale of 0 to 10 cm. This will be recorded by the patient prior to going to bed. | Patient will record her average pain on postop day 1. She will return this result at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Second Stage PACU Postoperative Pain | Visual analog scale (VAS) on scale of 0 to 10 cm will be used to evaluate the pain score experienced upon admission to second stage PACU. | The PACU nurse will record the patient's pain level upon admission to second stage PACU. These results will be examined and compared at the completion of the study. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charbel Salamon, MD | Atlantic Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Morrristown Medical Center | Morristown | New Jersey | 07960 | United States | ||
| Overlool Medical Center |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D008012 | Lidocaine |
| D053825 | Suburethral Slings |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
| Bupivacaine Hydrochloride and Lidocaine | Drug | Bupivacaine Hydrochloride (HCL) and Lidocaine. Fifty mL of 0.05% Marcaine and 30 mL of Lidocaine will be diluted in 100 mL of injectable saline used for hydro-dissection of the vesicovaginal space and along the track of the sling trocars during the placement of a suburethral sling. |
|
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| Suburethral Sling | Procedure | A retropubic, transobturator or mini-sling will be placed in the usual fashion followed by diagnostic cystoscopy. |
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| Postoperative Pain Upon Discharge |
Visual analog scale (VAS) on scale of 0 to 10 cm will be used to evaluate the pain score experienced upon discharge from the hospital. |
| The PACU nurse will record the patient's pain level upon discharge to home. These results will be examined and compared at the completion of the study. |
| Postoperative Pain Four Hours After Discharge | Visual analog scale (VAS) on scale of 0 to 10 cm will be used to evaluate the pain score experienced. This will be recorded 4 hours after being discharged from the hospital. | Record the average pain 4 hours after discharge to home. She will return this result at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study. |
| Night of Surgery Postoperative Pain | Visual analog scale (VAS) on scale of 0 to 10 cm will be used to evaluate the pain score experienced that day and recorded prior to going to bed on the night of surgery. | Pt will record her average pain on the night of surgery. She will return this result at her postop visit which is approximately 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study. |
| Postoperative Days 2 through 7 Pain | Visual analog scale (VAS) on scale of 0 to 10 cm will be used to evaluate the pain score experienced that day and recorded prior to going to bed on postop days 2-7. | Pt will record her average pain from postop days 2-7. She will return this result at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study. |
| Preoperative Quality of Recovery | Baseline Quality of Life and Recovery as measured by the ambulatory QoR15 preoperatively on the day of surgery. | The patient will complete the questionnaire prior to surgery. This will be collected prior to surgery. These results will be examined and compared at the completion of the study. |
| Postoperative Days 1, 7 and 14 Quality of Recovery | Quality of Life and Recovery as measured by the ambulatory QoR15 on postoperative days 1, 7 and 14. | The patient will complete the questionnaire on postop days 1, 7 & 14. She will return these results at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study. |
| Postoperative Narcotic Consumption | The total amount of narcotic taken the night of surgery and each day thereafter through postoperative day seven will be recorded each night prior to going to bed. | The patient will record narcotic consumption each day from the day of surgery to postop day 7. She will return this result at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study. |
| Summit |
| New Jersey |
| 07901 |
| United States |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |
| D000083 | Acetanilides |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |