A Trial of Levator Muscle Blocks Following Posterior Colporrhaphy Surgery to Reduce Post-operative Pain.

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Double Blinded, Randomized Controlled Trial of Levator Muscle Blocks Following Posterior Colporrhaphy Surgery to Reduce Post-operative Pain.

Conditions
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Post Operative Pain

Intervention / Treatment
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* Drug: Bupivacaine
* Drug: normal saline 0.9%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any woman over the age of 18 years with a capacity to give informed consent who are undergoing vaginal prolapse surgery including a posterior colporrhaphy may be included in the study. Exclusion Criteria: Any woman who is a non-English speaker, does not have ability to provide consent, has a cardiac arrhythmia, liver disease, myasthenia gravis, bleeding diathesis or adverse reaction / allergy to anesthetic will be excluded. Women that are also having vaginal mesh excisions at the time of prolapse repair or those that will undergo subsequent surgery in the follow up period will be excluded.

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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Accepts Healthy Volunteers

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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bupivacaine Arm<br>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. | Drug: Bupivacaine<br>* 5 mL of 0.5% bupivacaine will be injected into 2 locations bilaterally.<br>* Other names: Marcaine;|
| Placebo Comparator: Placebo Arm<br>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. | Drug: normal saline 0.9%<br>* 5 mL of 0.9% normal saline will be injected into 2 locations bilaterally.<br>* Other names: Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |