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?

The purpose of this research is to determine if using perineal ice packs, medicated witch-hazel pads (MAJOR® Medi-Pads), and topical benzocaine spray (Dermoplast®) helps reduce perineal pain after perineorrhaphy and/or posterior colporrhaphy surgery.

Who Is on the Research Team?

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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.
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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+