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

NCT03040011 | Completed Phase 1 Results FDA Drug

• 1 other identifier: PRO16110378
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

To test the hypothesis that preoperative injections along the levator ani muscles and pudendal nerve with bupivacaine and dexamethasone improve pain control after vaginal apical reconstructive surgery. A three-arm, double-blinded, randomized controlled trial of a total of 75 women will be performed. The study population will be adult women (\>18 years of age) with uterovaginal or vaginal vault prolapse who have been scheduled for native tissue vaginal reconstructive surgery which includes an apical support procedure. Participants will be enrolled prior to surgery. The procedure will involved four injection sites: the bilateral levator ani muscles via a transobturator approach and bilateral pudendal nerves via a transvaginal approach. Random assignment will occur to one of three study arms: combined arm (20 milliliters bupivacaine/dexamethasone solution divided between the 4 injection sites), bupivacaine arm (20 milliliters bupivacaine divided between the 4 injection sites), or placebo arm (20 milliliters saline divided between the 4 injection sites).

Conditions

Pelvic Organ Prolapse; Surgery; Postoperative Pain

Keywords

Vaginal Surgery; Pelvic Organ Prolapse; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Primary Postoperative Pain Measured by the Numerical Rating Scale (NRS)

  Postoperative pain measured by the numerical rating scale (NRS) at 24 hours postoperatively. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.

  24 hours postoperatively

Secondary Outcomes (19)

• 6 Hour Postoperative Pain Measured by the NRS

  6 hours postoperatively

• POD 2 Postoperative Pain Measured by the NRS

  2 days after surgery

• POD 3 Postoperative Pain Measured by the NRS

  3 days after surgery

• 1 Week Postoperative Pain Measured by the NRS

  1 week after surgery

• Proportion of Patients With Same Day Discharge

  Day of surgery

Study Arms (3)

Bupivacaine/Dexamethasone Arm

EXPERIMENTAL

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen (transobturator). After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.

Drug: Dexamethasone; Drug: Bupivacaine; Procedure: Bilateral Pudendal Nerve Block; Procedure: Bilateral Levator Ani Muscle Injection

Bupivacaine Arm

ACTIVE COMPARATOR

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen (transobturator). After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.

Drug: Bupivacaine; Procedure: Bilateral Pudendal Nerve Block; Procedure: Bilateral Levator Ani Muscle Injection

Placebo Arm

PLACEBO COMPARATOR

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen (transobturator). After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.

Procedure: Bilateral Pudendal Nerve Block; Procedure: Bilateral Levator Ani Muscle Injection; Drug: Saline

Interventions

Dexamethasone DRUG

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

Also known as: Decadron

Bupivacaine/Dexamethasone Arm

Bupivacaine DRUG

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

Also known as: Marcaine

Bupivacaine Arm; Bupivacaine/Dexamethasone Arm

Bilateral Pudendal Nerve Block PROCEDURE

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.

Bupivacaine Arm; Bupivacaine/Dexamethasone Arm; Placebo Arm

Bilateral Levator Ani Muscle Injection PROCEDURE

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.

Bupivacaine Arm; Bupivacaine/Dexamethasone Arm; Placebo Arm

Saline DRUG

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

Also known as: Normal Saline

Placebo Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women ages 18 or older who are scheduled for a vaginal native tissue repair with apical support procedure including uterosacral ligament suspension, sacrospinous ligament fixation, or colpectomy and colpocleisis with or without levator myorrhaphy
• Available for at least 12 weeks of follow-up
• Able to undergoing general anesthesia

You may not qualify if:

• Planned mesh excision
• Laparoscopic, robotic or abdominal surgery
• Known adverse reaction or allergy to intervention medication
• Evidence of fistula or known infection (vulvovaginal cellulitis, abscess, abdominopelvic infection, or systemic fungal infection)
• Chronic pelvic pain as an active issue
• Daily opiate consumption for any indication
• History of pelvic radiation
• Chronic steroid use
• Diabetes mellitus
• Known HIV/AIDS or immunosuppression secondary to transplant related medications
• Planned surgery under regional anesthesia
• Non-English speaking or inability to complete questionnaires
• Bleeding disorders that would impair a patient's clotting ability
• Weight less than 50kg

Sponsors & Collaborators

• Lauren Giugale, MD: lead
• Magee-Women's Research Institute: collaborator

Study Sites (1)

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (4)

• Dexamethasone (systemic): Drug information. UpToDate; 2016. Accessed November 9, 2016.

  BACKGROUND

• Bupivacaine: Drug Information. UpToDate; 2016.

  BACKGROUND

• Hsu D. Infiltration of local anesthetics. UpToDate. 2016. Accessed November 30, 2016.

  BACKGROUND

• Giugale LE, Baranski LA, Meyn LA, Schott NJ, Emerick TD, Moalli PA. Preoperative Pelvic Floor Injections With Bupivacaine and Dexamethasone for Pain Control After Vaginal Prolapse Repair: A Randomized Controlled Trial. Obstet Gynecol. 2021 Jan 1;137(1):21-31. doi: 10.1097/AOG.0000000000004205.

  PMID: 33278291 DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse; Pain, Postoperative

Interventions

Dexamethasone; Calcium Dobesilate; Bupivacaine; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Anilides; Amides; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Lauren Giugale, PI
• Organization: Magee-Womens Hospital of UPMC

giugalele@upmc.edu

412-641-1498

Study Officials

• Lauren Giugale, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Model Details: Three-arm, double-blinded, placebo-controlled, randomized controlled trial

Study Record Dates

• First Submitted: January 25, 2017
• First Posted: February 1, 2017
• Study Start: June 1, 2017
• Primary Completion: April 11, 2019
• Study Completion: August 5, 2019
• Last Updated: March 9, 2020
• Results First Posted: March 9, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)