Multimodal Perineal Analgesia for Postoperative Recovery

TY
KA
Overseen ByKatherine Amin, MD
Age: 18+
Sex: Female
Trial Phase: Phase 4
Sponsor: University of Miami
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a combination of perineal ice packs, witch-hazel pads, and benzocaine spray (part of the Multimodal Perineal Analgesia Protocol) can reduce pain after certain pelvic surgeries. The goal is to determine if this approach helps women recover more comfortably compared to standard post-surgery care. Women who have undergone surgeries like perineorrhaphy or posterior colporrhaphy and can use these products independently might be suitable candidates. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand its benefits for more patients.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you are using opioid pain medication continuously for more than three weeks, you may not be eligible to participate.

What is the safety track record for the Multimodal Perineal Analgesia Protocol (MPAP)?

Research shows that perineal ice packs, medicated witch-hazel pads, and benzocaine spray effectively reduce pain after certain surgeries. These treatments form a key part of pain management strategies, considered best practice for post-operative pain relief.

These treatments are generally safe, with few reports of serious side effects. Perineal ice packs reduce swelling and discomfort, witch-hazel pads soothe irritated skin, and benzocaine spray numbs the area to ease pain. As this study is in a later phase, these treatments have been tested in people before and have proven safe.12345

Why are researchers enthusiastic about this trial?

Researchers are excited about the Multimodal Perineal Analgesia Protocol (MPAP) because it combines several pain relief methods into one comprehensive approach. Unlike standard post-operation care, which typically involves just scheduled pain relievers and basic perineal hygiene, MPAP offers additional options like perineal ice packs, medicated witch-hazel pads, and a benzocaine spray with aloe. These elements aim to provide more targeted and effective pain management, potentially leading to a quicker and more comfortable recovery for patients. This multimodal approach is what sets MPAP apart and could redefine how postoperative perineal pain is managed.

What evidence suggests that the Multimodal Perineal Analgesia Protocol is effective for reducing perineal pain?

Research has shown that the Multimodal Perineal Pain Relief Plan (MPAP), which participants in this trial may receive, effectively reduces pain after surgeries like perineorrhaphy and posterior colporrhaphy. Studies have found that a combination of perineal ice packs, medicated witch-hazel pads, and benzocaine spray helps manage mild to moderate pain. This method also reduces the need for opioid painkillers by 35% to 45%, aiding recovery. Overall, the MPAP improves pain control and speeds up recovery after surgery.12467

Who Is on the Research Team?

KA

Katherine Amin, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for women aged 18 or older who can apply witch-hazel pads and benzocaine spray to the perineal area themselves. They should understand the study and agree to participate, undergoing vaginal surgery like perineorrhaphy or posterior colporrhaphy.

Inclusion Criteria

I am a woman aged 18 or older.
I am having surgery to repair pelvic floor damage.
I can apply medicated pads and spray to the perineal area by myself.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive the Multimodal Perineal Analgesic Protocol (MPAP) or normal post-operation care

7 days
Daily monitoring through participant diaries

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks
1 visit (in-person) at 2 weeks post-operation

What Are the Treatments Tested in This Trial?

Interventions

  • Multimodal Perineal Analgesia Protocol (MPAP)

Trial Overview

The study tests if using ice packs, witch-hazel pads (MAJOR® Medi-Pads), and topical benzocaine spray (Dermoplast®) reduces pain after surgeries repairing tissues in the vaginal area.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Multimodal Perineal Analgesic Protocol (MPAP)Experimental Treatment1 Intervention
Group II: Normal Post-Operation CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials
976
Recruited
423,000+

Citations

Improving Postoperative Recovery: A Study of Multimodal ...

Improving Postoperative Recovery: A Study of Multimodal Perineal Analgesia Protocol (MPAP) After Vaginal Surgery. ClinicalTrials.gov ID NCT07401134. Sponsor ...

Impact of multimodal analgesia nursing on postoperative pain ...

Multimodal analgesia nursing effectively improves postoperative pain control, accelerates recovery, reduces complications, and enhances patient ...

Multimodal Perineal Analgesia for Postoperative Recovery

The study tests if using ice packs, witch-hazel pads (MAJOR® Medi-Pads), and topical benzocaine spray (Dermoplast®) reduces pain after surgeries ...

A Study of Multimodal Perineal Analgesia Protocol (MPAP ...

Description: Participants will follow the Multimodal Perineal Analgesic Protocol (MPAP) in addition to their normal post-operation care.

The clinical application progress of multimodal analgesia ...

In addition to being effective for mild and moderate pain, it can reduce the amount of opioids used after surgery by 35%–45% (54). 4.1.2 Alpha-2 receptor ...

The clinical application progress of multimodal analgesia ...

At present, multimodal analgesia (MMA) strategy has been widely recommended as the gold standard for postoperative pain management. This paper ...

Multimodal analgesia strategies for optimal postoperative ...

This narrative review assesses the effectiveness of multimodal analgesia protocols (MAPs) in managing postoperative pain and reducing opioid consumption.