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| Name | Class |
|---|---|
| University of Kansas Medical Center | OTHER |
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To determine if levator muscle block with bupivacaine improves postoperative pain control relative to placebo controls among women undergoing prolapse surgery involving a posterior colporrhaphy. Improvement is defined as no less than a 25% lower total pain score on a ten point numerical pain scale.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacaine Arm | Active Comparator | The subjects of this arm will receive an injection of 5mL of 0.5% bupivacaine, 1-2 cm deep to the surface of the vaginal epithelium into the levator ani muscle, puborectalis. A second injection of 5mL of 0.5% bupivacaine, 1-2 cm deep to the surface of the vaginal epithelium will be repeated on the same side, approximately 2-3 cm cephalad of the first injection at the iliococcygeus muscle. These 2 injections will then be repeated on the contralateral side. |
|
| Placebo Arm | Placebo Comparator | The subjects of this arm will receive an injection of 5mL of 0.9% normal saline, 1-2 cm deep to the surface of the vaginal epithelium into the levator ani muscle, puborectalis. A second injection of 0.9% normal saline, 1-2 cm deep to the surface of the vaginal epithelium will be repeated on the same side, approximately 2-3 cm cephalic from first injection at the iliococcygeus muscle. These 2 injections will then be repeated on the contralateral side. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | 5 mL of 0.5% bupivacaine will be injected into 2 locations bilaterally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with improvement in pain, scored on a 10 point numerical pain scale. | Improvement is defined as a 25% or lower total pain score on a ten point numerical pain scale compared to placebo. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative care satisfaction scores, graded with a post-operative survey. | Improvement in satisfaction is defined as an overall satisfaction score of 20% or more on the post-operative survey compared to placebo. | 1 year |
| Measure of morphine equivalents used in patients postoperatively. |
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Inclusion Criteria:
Exclusion Criteria:
Patients that are eligible would be undergoing vaginal prolapse surgery including posterior colporrhaphy, therefore would need to have a vagina to be enrolled in this study
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| Name | Affiliation | Role |
|---|---|---|
| Carson T Kaeser, MD | The Christ Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States | ||
| The Christ Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34171880 | Derived | Kaeser CT, Rothenberger R, Zoorob D, Whiteside JL. Bupivacaine Use After Posterior Colporrhaphy to Reduce Postoperative Pain: A Multicenter, Double-Blinded, Placebo-Controlled, Randomized Clinical Trial. Female Pelvic Med Reconstr Surg. 2022 Feb 1;28(2):72-76. doi: 10.1097/SPV.0000000000001082. |
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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 |
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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Subjects will not know if they received an injection of bupivacaine or placebo, i.e., normal saline after completion of surgery. The surgeon, as well as any investigator or study personnel, will be blinded to injection type.
| normal saline 0.9% | Drug | 5 mL of 0.9% normal saline will be injected into 2 locations bilaterally. |
|
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A reduction in opiate use is defined as a 20% reduction in total number of morphine equivalents used between study cohorts. |
| 1 year |
| Length of hospital stay measured in hours. | Length, in hours, of hospital stay between study cohorts. | 1 year |
| Cincinnati |
| Ohio |
| 45219 |
| United States |
| The University of Toledo | Toledo | Ohio | 43606 | United States |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |