The Effect of Preemptive Levator Ani Injections on Pain After Pelvic Reconstructive Surgery

NCT ID: NCT04428320

Last Updated: 2020-06-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-21
• Study Completion Date: 2022-05-21

Brief Summary

Patients undergoing vaginal pelvic reconstructive surgery for pelvic organ prolapse (POP) under general anesthesia will be randomized to receive bilateral trans-vaginal pelvic floor muscle injections with bupivacaine or no injection (standard of care) as a part of their surgical pain control

Detailed Description

Patients undergoing vaginal pelvic reconstructive surgery for pelvic organ prolapse (POP) under general anesthesia will be randomized to receive:

1. Bilateral trans- vaginal pelvic floor levator ani muscle injections (trigger point injections) with bupivacaine:

• 0.5% bupivacaine will be injected at several sites for a total of 5ml on each side of the pelvic floor, with each injection site no more than 1 ml (Bupivacaine was chosen by the study team because of it has a longer half life then other common local anesthetics. We plan to use the same anesthetic and dosage to standardize the protocol between patients. Other local anesthetics will not be used in addition to the bupivacaine administered for research purposes. We will limit the amount of intravenous lidocaine to less than 5mg/ kg).

2. Control- No additional treatment (standard of care).

The patient will be blinded to their randomization (single blind). The post-operative pain regimen will be standardized when possible. Patients will receive a regimen of IV and oral narcotics and Ketorolac per our routine post-operative protocol. On discharge from the hospital, patients will be given prescriptions for a standard amount of oral narcotic, 20 tablets of oxycodone (150 morphine equivalents), and 30 tablets of 600mg ibuprofen.

Conditions

Pelvic Floor Prolapse; Surgery; Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Bupivicaine pelvic floor muscle injection

Five injections at pre-specified locations at pelvic floor muscle bilaterally after induction of general anesthesia for vaginal pelvic prolapse surgery

Group Type: EXPERIMENTAL

Pelvic floor injection

Intervention Type: PROCEDURE

Injection of 10 cc of bupivacaine

Standard of care (no injection) preoperatively

No injection - standard analgesia

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pelvic floor injection

Injection of 10 cc of bupivacaine

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Female
• Able to read English and give informed consent
• Undergoing VAGINAL pelvic reconstructive surgery for POP

Exclusion Criteria

• Hypersensitivity or allergy to amide anesthetics
• Documented chronic pain condition

o (back pain, pelvic pain, fibromyalgia, etc.)

• Bleeding disorder
• Connective tissue disorder
• Neuromuscular disorder
• Cardiac conduction abnormality or channelopathy
• Hepatic Impairment
• Renal Impairment
• History of, or current, narcotic or alcohol dependence
• History of pelvic radiation or gynecologic malignancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Cooper Health System

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cooper Health University

Camden, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lioudmila Lipetskaia, MD

Role: CONTACT

lipetskaia-lioudmila@cooperhealth.edu

610-462-608

Devon Smith, MD

Role: CONTACT

smith-devon@cooperhealth.edu

Facility Contacts

Lioudmila Lipetskaia

Role: primary

lipetskaia-lioudmila@cooperhealth.edu

610-462-1608

Other Identifiers

19-124

Identifier Type: -

Identifier Source: org_study_id