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Pudendal Nerve Block for Pain Management
Phase 4
Waitlist Available
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Undergoing vaginal reconstructive surgery of at least 2 compartments (anterior vaginal wall, posterior vaginal wall, and/or apical suspension including hysteropexy, uterosacral ligament suspension, or sacrospinous ligament fixation)
Female
Timeline
Screening 3 weeks
Treatment Varies
Follow Up tracked by hour through time of patient discharge (0 - 72 hours)
Awards & highlights
Study Summary
This trial is testing whether an extra injection of numbing medication during vaginal reconstructive surgery decreases postoperative pain. Patients will be randomly assigned to either receive the injection or not, and their pain levels will be monitored for 6 weeks after surgery.
Who is the study for?
This trial is for English-speaking women over 18 who are having vaginal reconstructive surgery involving at least two areas. They must be able to tolerate local anesthetics, NSAIDs, opioids, and acetaminophen. It's not for those with allergies to these drugs, coagulation disorders, chronic pain syndromes on regular opioids before surgery or if they're getting a hysterectomy.Check my eligibility
What is being tested?
The PEERS trial tests whether adding a pudendal nerve block (an extra numbing injection) to standard anesthesia improves pain management after vaginal reconstructive surgery. Participants have a 50% chance of receiving this additional injection and will be monitored for six weeks through phone surveys and an office visit.See study design
What are the potential side effects?
Potential side effects may include reactions to the local anesthetic used in the pudendal nerve block such as allergic reactions or increased sensitivity at the injection site. Since care is otherwise unchanged, usual surgical risks apply.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am having surgery to repair at least two parts of my vagina.
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I am female.
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I am older than 18 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ tracked by hour through time of patient discharge (0 - 72 hours)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~tracked by hour through time of patient discharge (0 - 72 hours)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Narcotic use
Secondary outcome measures
Length of hospital stay
Pain scores
Patient satisfaction with postoperative recovery
+1 moreTrial Design
2Treatment groups
Active Control
Group I: Group 2: Local Anesthesia plus Pudendal Nerve BlockActive Control1 Intervention
Pudendal Nerve Block (PNB) in addition to local anesthesia used during surgery
Group II: Group 1: Local AnesthesiaActive Control1 Intervention
Standard of care with local anesthesia used during surgery
Find a Location
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,530 Previous Clinical Trials
10,278,122 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot take opioids due to an allergy or a medical reason.I am having surgery to repair at least two parts of my vagina.I have a blood clotting disorder.You cannot use local anesthetic agents due to allergy or medical reasons.I cannot take NSAIDs due to an allergy or other medical reasons.I regularly use opioid medication for chronic pain before surgery.I had a hysterectomy during my surgery.I am female.I am older than 18 years.I cannot take acetaminophen due to an allergy or other medical reason.
Research Study Groups:
This trial has the following groups:- Group 1: Group 2: Local Anesthesia plus Pudendal Nerve Block
- Group 2: Group 1: Local Anesthesia
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are senior citizens being included in the data collection for this research?
"To be eligible for enrollment in this research, individuals must have surpassed the age of majority but not yet reached their centennial birthday."
Answered by AI
Is enrollment for this investigation still open?
"Clinicaltrials.gov states that this particular medical trial is no longer recruiting participants; the listing was initially put up on November 14th 2019 and last amended July 20th 2022. Despite the closure of this study, 34 other research initiatives are still actively enrolling subjects."
Answered by AI
To what extent is Group 1: Local Anesthesia considered safe for people?
"Considering that Group 1: Local Anesthesia has received approval from regulatory bodies, there is significant evidence of safety and our team at Power awarded it a score of 3."
Answered by AI
What patient demographics are best suited for this clinical trial?
"This trial is currently accepting patients with chronic pain and between 18 to 99 years of age. A total of 80 participants have been targeted for enrollment."
Answered by AI
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