Improving Postoperative Recovery: A Study of Multimodal Perineal Analgesia Protocol (MPAP) After Vaginal Surgery

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT07401134
Phase
PHASE4
Status
Recruiting

Conditions

  • Pain Vulva
  • Perineal Injury
  • Perineum; Injury

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Perineal ice packs, medicated witch-hazel pads, and topical benzocaine spray — DRUG
    Participants will follow the Multimodal Perineal Analgesic Protocol (MPAP) in addition to their normal post-operation care. Participants will receive a Perineal Care Kit prior to discharge from the hospital. This kit will contain 14 perineal ice packs, one container of 100 medicated witch-hazel pads (MAJOR® Medi-Pads), and one 2.75 oz can of 20% benzocaine with aloe spray (Dermoplast®). Participants will receive written instructions for use of these products.

Study Details

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.

Key Dates

Start date
Feb 18, 2026
Status verified
Mar 2026
Primary completion
Jan 31, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Multimodal Perineal Analgesic Protocol (MPAP)
    Participants will follow the Multimodal Perineal Analgesic Protocol (MPAP) in addition to their normal post-operation care. Participants will receive a Perineal Care Kit prior to discharge from the hospital. This kit will contain: * 14 perineal ice packs * One container of 100 medicated witch-hazel pads (MAJOR® Medi-Pads) * One 2.75 oz can of 20% benzocaine with aloe spray (Dermoplast®) Participants will also receive standard discharge instructions, including guidance on perineal hygiene, scheduled pain relievers, activity restrictions, constipation prevention, and catheter care if a catheter has been placed.
  • No Intervention: Normal Post-Operation Care
    Participants will receive standard discharge instructions, including guidance on perineal hygiene, scheduled pain relievers, activity restrictions, constipation prevention, and catheter care if a catheter has been placed.

Primary Outcome Measure

Difference in Perineal Pain Score on Postoperative Day (POD) 3 Between Control and Interventional Groups [ Time Frame: 3 Days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Miami Hospitals and ClinicsMiamiFlorida33136
Elena Cortizas
305-243-3593
Katherine Amin, MD (PRINCIPAL_INVESTIGATOR)
Raveen Syan, MD (SUB_INVESTIGATOR)
Tamar Yacoel, MD (SUB_INVESTIGATOR)
Ricardo Palmerola, MD (SUB_INVESTIGATOR)

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