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Patients undergoing vaginal pelvic reconstructive surgery for pelvic organ prolapse (POP) under general anesthesia will be randomized to receive bilateral trans-vaginal pelvic floor muscle injections with bupivacaine or no injection (standard of care) as a part of their surgical pain control
Patients undergoing vaginal pelvic reconstructive surgery for pelvic organ prolapse (POP) under general anesthesia will be randomized to receive:
Bilateral trans- vaginal pelvic floor levator ani muscle injections (trigger point injections) with bupivacaine:
- 0.5% bupivacaine will be injected at several sites for a total of 5ml on each side of the pelvic floor, with each injection site no more than 1 ml (Bupivacaine was chosen by the study team because of it has a longer half life then other common local anesthetics. We plan to use the same anesthetic and dosage to standardize the protocol between patients. Other local anesthetics will not be used in addition to the bupivacaine administered for research purposes. We will limit the amount of intravenous lidocaine to less than 5mg/ kg).
Control- No additional treatment (standard of care).
The patient will be blinded to their randomization (single blind). The post-operative pain regimen will be standardized when possible. Patients will receive a regimen of IV and oral narcotics and Ketorolac per our routine post-operative protocol. On discharge from the hospital, patients will be given prescriptions for a standard amount of oral narcotic, 20 tablets of oxycodone (150 morphine equivalents), and 30 tablets of 600mg ibuprofen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivicaine pelvic floor muscle injection | Experimental | Five injections at pre-specified locations at pelvic floor muscle bilaterally after induction of general anesthesia for vaginal pelvic prolapse surgery |
|
| Standard of care (no injection) preoperatively | No Intervention | No injection - standard analgesia |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pelvic floor injection | Procedure | Injection of 10 cc of bupivacaine |
|
| Measure | Description | Time Frame |
|---|---|---|
| VAS analog scale on post-op day #1 | postop day #1 |
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Inclusion Criteria:
Exclusion Criteria:
Hypersensitivity or allergy to amide anesthetics
Documented chronic pain condition
o (back pain, pelvic pain, fibromyalgia, etc.)
Bleeding disorder
Connective tissue disorder
Neuromuscular disorder
Cardiac conduction abnormality or channelopathy
Hepatic Impairment
Renal Impairment
History of, or current, narcotic or alcohol dependence
History of pelvic radiation or gynecologic malignancy
Pelvic organ prolapse surgery for female genitalia
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lioudmila Lipetskaia, MD | Contact | 610-462-608 | lipetskaia-lioudmila@cooperhealth.edu | |
| Devon Smith, MD | Contact | smith-devon@cooperhealth.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cooper Health University | Recruiting | Camden | New Jersey | 08105 | United States |
No sharing planned as of now
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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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Randomized Control Trial
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |