Use of Pre-Emptive Pudendal Nerve Block for Pelvic Reconstructive Surgery

Study Overview
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Brief Summary
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The purpose of this study is to determine the effectiveness of perineal pain control via injection of a local anesthetic to numb the pudendal nerve. The medication which is commonly used for this block is called marcaine. This is called a pudendal block it has been used in obstetrical and gynecologic surgeries for several decades. The goal of this study is to reduce the amount of pain medications taken post operatively after pelvic reconstructive surgery. Subjects undergoing pelvic reconstructive surgery will be recruited during the pre-op visit. Subjects will be asked about their pain level in the PACU and also asked to document their pain score days 1 and 2 post op. They will also be asked to keep a medication log for 14 days post op.

Detailed Description
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Subjects will have a through physical exam with evolution of the pelvis support using the POP-Q (pelvic organ prolapse quantification) system. All subjects will need to sign informed consent pre-approved by the IRB. The subjects, surgeons, and anesthesiologist will all be blinded to the injected material. The OR Scrub nurse will given the envelope at the start of each case and asked to draw the material into a syringe. All subjects will receive general anesthesia. Subjects will be randomized to receive preemptive pudendal nerve blockade with 10 ml of 0 .5 % Bupivacaine with epinephrine or normal saline to each side. The allocation schedule is computer generated using random-numbers table concealed in opaque envelops. Once the patient receives general anesthesia she will be positioned appropriately in dorsal lithotomy with padded Allan stir ups. 10 ml of Bupivacaine will be injected on either side using the Iowa trumpet pudendal needle drive to direct and guide appropriate position. Aspiration was attempted for every injection to decrease the chance of intravascular infusion. At the completion of the surgery the subjects will be brought to the PACU for care. Patients are assessed immediately upon arrival to the PACU. The patients are asked their pain level using the VAS pain scale/ modified surgical pain scale at hours 1 and 2 post op. All patients are given a prescription for Vicoprofen 7.5/200mg at their pre-op visit and asked to have it filled prior to their surgery. Patients have the option to go home the same day of surgery as long as their pain is well controlled and they are clinically stable for discharge. Continued pain management and pain scale assessment will be done at 4 hours, and post op day 1 and 2. A medication log will be kept for 2 weeks post op, detailing the number of pain medications taken during that period.

Official Title
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A Randomized Controlled Trial of Use of Pre-emptive Pudendal Nerve Block for Pelvic Reconstructive Surgery

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Drug: pudendal block
* Drug: no pudendal block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The ability to read and understand English Be at least 18 years old Symptomatic Stage 2 prolapse Exclusion Criteria: Intolerance to local anesthetics or narcotics History of major psychiatric disorder or chronic pain syndrome History of substance abuse or current narcotic use

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: pudendal block<br>preemptive pudendal nerve blockade with 10 ml of 0 .5 % Bupivacaine with epinephrine. 10 ml of Bupivacaine will be injected on either side using the pudendal nerve block tray. | Drug: pudendal block<br>* preemptive pudendal nerve blockade with 10 ml of 0 .5 % Bupivacaine with epinephrine.<br>* Other names: Marcaine;|
| Placebo Comparator: no pudendal block<br>Saline | Drug: no pudendal block<br>* preemptive pudendal nerve blockade with 10 ml of normal saline to each side<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS pain scale |  | up to 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post operative analgesic consumption |  | up to 2 weeks | 
| adverse effect of the pudendal block |  | up to 2 weeks | 
| Length of hospital stay |  | up to 2 weeks | 
| Medical or surgical complications |  | up to 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pudendal nerve block, vaginal reconstructive surgery