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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04428320
Enrollment
140
Registered
2020-06-11
Start date
2020-05-21
Completion date
2022-05-21
Last updated
2020-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative, Pelvic Floor Prolapse, Surgery

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.

Interventions

PROCEDUREPelvic floor injection

Injection of 10 cc of bupivacaine

Sponsors

The Cooper Health System
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

Randomized Control Trial

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
VAS analog scale on post-op day #1postop day #1

Countries

United States

Contacts

Primary ContactLioudmila Lipetskaia, MD
lipetskaia-lioudmila@cooperhealth.edu610-462-608
Backup ContactDevon Smith, MD
smith-devon@cooperhealth.edu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026