The Effect of Preemptive Levator Ani Injections on Pain After Pelvic Reconstructive Surgery

Study Overview
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Brief Summary
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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

Detailed Description
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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 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.

Official Title
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The Effect of Preemptive Levator Ani Injections on Pain After Pelvic Reconstructive Surgery

Conditions
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Pelvic Floor Prolapse, Surgery, Pain, Postoperative

Intervention / Treatment
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* Procedure: Pelvic floor injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female Able to read English and give informed consent Undergoing VAGINAL pelvic reconstructive surgery for POP 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Control Trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bupivicaine pelvic floor muscle injection<br>Five injections at pre-specified locations at pelvic floor muscle bilaterally after induction of general anesthesia for vaginal pelvic prolapse surgery | Procedure: Pelvic floor injection<br>* Injection of 10 cc of bupivacaine<br>|
| No Intervention: Standard of care (no injection) preoperatively<br>No injection - standard analgesia | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS analog scale on post-op day #1 |  | postop day #1 |