Pelvic Floor ProlapseNCT04428320
The Effect of Preemptive Levator Ani Injections on Pain After Pelvic Reconstructive Surgery
A study testing Pelvic floor injection in people with Pelvic Floor Prolapse and Surgery, run by Cooper Norcross Health at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Floor Prolapse, Surgery, Pain, Postoperative
- What is being tested?
- Pelvic floor injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2020to 21 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Able to read English and give informed consent
- Undergoing VAGINAL pelvic reconstructive surgery for POP
Who cannot join
- Hypersensitivity or allergy to amide anesthetics
- Documented chronic pain condition
- o (back pain, pelvic pain, fibromyalgia, etc.)
- Bleeding disorder
- Connective tissue disorder
- Neuromuscular disorder
Show all 11Show fewer
- Cardiac conduction abnormality or channelopathy
- Hepatic Impairment
- Renal Impairment
- History of, or current, narcotic or alcohol dependence
- History of pelvic radiation or gynecologic malignancy
Trial locations and contacts
1 site in 1 country.
Devon Smith, MD contact
United States1 site, 1 recruiting
- Recruiting
Cooper Health University
Camden, New Jersey, 08105
Lioudmila Lipetskaia, 610-462-1608, lipetskaia-lioudmila@cooperhealth.edu
About this study
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
Read the detailed description
Patients undergoing vaginal pelvic reconstructive surgery for pelvic organ prolapse (POP) under general anesthesia will be randomized to receive:
- 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).
- 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
- Being tested
- Pelvic floor injection
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor injectionProcedure or surgery
Injection of 10 cc of bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Pelvic floor injection |
| Standard of care (no injection) preoperatively | No intervention | No injection - standard analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS analog scale on post-op day #1
Measured: postop day #1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start21 May 2020
- Primary completion21 May 2022 (estimated)
- Study completion21 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Control Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cooper Norcross Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04428320
- Sponsor's protocol ID
- 19-124
- Status last verified
- Jun 2020
- First submitted
- 9 Jun 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No sharing planned as of now
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preemptive Levator Ani Injections on Pain After Pelvic Reconstructive Surgery
- ClinicalTrials.gov ID
- NCT04428320
- Acronym / sponsor ID
- 19-124
- Conditions
- Pelvic Floor Prolapse, Surgery, Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Cooper Norcross HealthUniversity, hospital or other
- Study start
- 21 May 2020 (actual)
- Primary completion
- 21 May 2022 (estimated)
- Study completion
- 21 May 2022 (estimated)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| Bupivicaine pelvic floor muscle injection | Experimental | Procedure: Pelvic floor injectionFive injections at pre-specified locations at pelvic floor muscle bilaterally after induction of general anesthesia for vaginal pelvic prolapse surgery |
| Standard of care (no injection) preoperatively | No intervention | –No injection - standard analgesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female
- Able to read English and give informed consent
- Undergoing VAGINAL pelvic reconstructive surgery for POP
Key exclusion criteria (11 listed)
- Hypersensitivity or allergy to amide anesthetics
- Documented chronic pain condition
- o (back pain, pelvic pain, fibromyalgia, etc.)
- Bleeding disorder
- Connective tissue disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic floor injectionInjection of 10 cc of bupivacaine | Procedure or surgery | Bupivicaine pelvic floor muscle injection |
Primary outcome
VAS analog scale on post-op day #1
Time frame: postop day #1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Individual participant dataSharing planned: No. No sharing planned as of now
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Devon Smith, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor injection in people with Pelvic Floor Prolapse and Surgery, run by Cooper Norcross Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lioudmila Lipetskaia, MD (610-462-608, lipetskaia-lioudmila@cooperhealth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS analog scale on post-op day #1 (time frame: postop day #1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.