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

NCT04428320 | Unknown

• 1 other identifier: 19-124
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Conditions

Pelvic Floor Prolapse; Surgery; Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• VAS analog scale on post-op day #1

  postop day #1

Study Arms (2)

Bupivicaine pelvic floor muscle injection

EXPERIMENTAL

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

Procedure: Pelvic floor injection

Standard of care (no injection) preoperatively

NO INTERVENTION

No injection - standard analgesia

Interventions

Pelvic floor injection PROCEDURE

Injection of 10 cc of bupivacaine

Bupivicaine pelvic floor muscle injection

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pelvic organ prolapse surgery for female genitalia
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cooper Health System: lead

Study Sites (1)

Cooper Health University

Camden, New Jersey, 08105, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Lioudmila Lipetskaia, MD

CONTACT

610-462-608; lipetskaia-lioudmila@cooperhealth.edu

Devon Smith, MD

CONTACT

smith-devon@cooperhealth.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Control Trial

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 11, 2020
• Study Start: May 21, 2020
• Primary Completion: May 21, 2022
• Study Completion: May 21, 2022
• Last Updated: June 11, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)