Preoperative Levator Ani Muscle Injection and Pudendal Nerve Block for Pain Control After Vaginal Reconstructive Surgery

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

79

Participants

Timeline

Start Date

June 1, 2017

Primary Completion Date

April 11, 2019

Study Completion Date

August 5, 2019

Conditions
Pelvic Organ ProlapseSurgeryPostoperative Pain
Interventions
DRUG

Dexamethasone

Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

DRUG

Bupivacaine

Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

PROCEDURE

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.

PROCEDURE

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.

DRUG

Saline

Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Trial Locations (1)

15213

Magee-Womens Hospital of UPMC, Pittsburgh

Sponsors
All Listed Sponsors
collaborator

Magee-Women's Research Institute

OTHER

lead

Lauren Giugale, MD

OTHER