79
Participants
Start Date
June 1, 2017
Primary Completion Date
April 11, 2019
Study Completion Date
August 5, 2019
Dexamethasone
Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.
Bupivacaine
Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.
Bilateral Pudendal Nerve Block
Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approximately 1cm through the vaginal mucosa into the sacrospinous ligament. The needle will be aspirated to ensure no intravascular needle placement. With a negative aspirate, 5 milliliters of solution are injected. This same procedure will be performed on the contralateral side.
Bilateral Levator Ani Muscle Injection
Performed transperineally. With thumb, superomedial aspect of obturator foramen is palpated 2-3 cm lateral to the clitoris. The index and middle finger are in the vagina to confirm obturator foramen. A spinal needle is inserted through the the obturator foramen into the obturator internus muscle. The needle is angled slightly posteriorly towards the ischial spine, parallel to the arcus tendineus levator ani and arcus tendineus fascia pelvis. The needle is advanced to the level of the ischial spine, the vaginal hand ensuring that the needle has not perforated the vaginal wall. Once the needle tip is at a depth of the ischial spine, aspiration is performed to ensure no intravascular needle placement. 5 milliliters of solution is injected along the length of the needle tract.
Saline
Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.
Magee-Womens Hospital of UPMC, Pittsburgh
Collaborators (1)
Magee-Women's Research Institute
OTHER
Lauren Giugale, MD
OTHER