What is the mechanism of action of this treatment?

Common treatments for Vulvodynia, such as local anesthetics and NSAIDs, work through different mechanisms to alleviate pain. Local anesthetics like bupivacaine block nerve signals, preventing the transmission of pain to the brain. NSAIDs like meloxicam inhibit COX enzymes, reducing inflammation and associated pain. These treatments are significant for Vulvodynia patients as they address both nerve-related and inflammatory pain, offering a more comprehensive approach to pain management.

What side effects are associated with this type of intervention?

Common treatments for Vulvodynia, such as local anesthetics (e.g., Bupivacaine) and NSAIDs (e.g., Meloxicam), have known side effects. Local anesthetics can cause localized numbness, allergic reactions, and rarely, systemic toxicity with symptoms like dizziness and seizures. NSAIDs can lead to gastrointestinal issues such as stomach pain, ulcers, and bleeding, as well as cardiovascular risks like hypertension and increased risk of heart attack or stroke. Combining these treatments may enhance pain relief but also carries the combined risk of their individual side effects.

What prior FDA approvals exist?

The FDA has not specifically approved a combination of a local anesthetic and an NSAID for the treatment of Vulvodynia. However, treatments involving local anesthetics like lidocaine and NSAIDs such as meloxicam are commonly used for pain management in various conditions. Lidocaine can be used topically to numb the affected area and reduce pain by blocking nerve signals, while NSAIDs like meloxicam reduce inflammation and pain through COX inhibition. These mechanisms are similar to the combination of Bupivacaine and Meloxicam being studied for other types of pain management.

What other types of research exist?

Promising alternatives to Bupivacaine-Meloxicam for vulvodynia treatment include: 1) Quadratus Lumborum Block (QLB) combined with other analgesics, which has shown effectiveness in various surgeries; 2) Gabapentin or Pregabalin, which are gabapentinoids used for chronic pain management; 3) Relugolix combination therapy, which has shown efficacy in reducing pelvic pain in endometriosis and may be applicable to vulvodynia; 4) Aromatase inhibitors, which are being explored for their pain-relieving properties in gynecologic conditions. These alternatives should be discussed with a healthcare provider to determine the best individualized treatment plan.

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Local Analgesic

Bupivacaine-Meloxicam for Surgical Incisions

Phase 3

Waitlist Available

Research Sponsored by TriHealth Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

English as first language

Undergoing retropubic mid-urethral sling surgery (with concomitant anterior repair or urethrocele repair)

Must not have

Long acting opioids within 3 days

Any opioids within 24h

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 72 hours post surgery

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing a combination of two pain-relief drugs applied directly to the surgical site in patients having a specific type of urinary incontinence surgery. The goal is to see if this combination can reduce pain and the need for narcotic painkillers.

Who is the study for?

This trial is for English-speaking patients having retropubic mid-urethral sling surgery, possibly with anterior or urethrocele repair. It's not for those getting additional surgeries like hysterectomy, can't consent, are allergic to the study drugs, pregnant/breastfeeding, recently used steroids or various painkillers.

What is being tested?

The study tests a combined local anesthetic (Bupivacaine-meloxicam) on abdominal incisions in sling surgery patients. It aims to see if this reduces the need for narcotics and lessens pain compared to current practices.

What are the potential side effects?

Potential side effects may include reactions at the injection site such as swelling or itching, possible nerve damage risks associated with injections near nerves, and typical drug-related issues like nausea or headaches.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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English is my first language.

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I am having surgery to support my bladder or urethra.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't taken long-acting opioids in the last 3 days.

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I have not taken any opioids in the last 24 hours.

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I am unable to give consent for my own medical treatment.

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I am having or have had surgery for pelvic organ prolapse or related conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 72 hours post surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~72 hours post surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours post surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To determine if use of bupivacaine-meloxicam reduces post-operative narcotic use over the first 3 days following surgery

Secondary study objectives

Compare average pain on each day post operatively

Compare satisfaction with pain control post operatively

Compare worst pain on each day post operatively

Awards & Highlights

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.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: bupivacaine-meloxicamExperimental Treatment1 Intervention

All patients will receive a total of 20 cc lidocaine with epinephrine injection intra-operatively along the trocar path via the suprapubic incisions, as is standard practice to help with hydrodissection for the procedure. 3-4 cc of bupivacaine-meloxicam will be infiltrated into each suprapubic abdominal incision in the study group

Group II: Standard of CareActive Control1 Intervention

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Vulvodynia, such as local anesthetics and NSAIDs, work through different mechanisms to alleviate pain. Local anesthetics like bupivacaine block nerve signals, preventing the transmission of pain to the brain. NSAIDs like meloxicam inhibit COX enzymes, reducing inflammation and associated pain. These treatments are significant for Vulvodynia patients as they address both nerve-related and inflammatory pain, offering a more comprehensive approach to pain management.

[Subarachnoid meloxicam does not inhibit the mechanical hypernociception on carrageenan test in rats].Behavioural assessment of the effects of tumour growth in rats and the influence of the analgesics carprofen and meloxicam.Systemic meloxicam reduces tactile allodynia development after L5 single spinal nerve injury in rats.