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 — DRUGParticipants 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 CareParticipants 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
- Katherine Amin, MD(305) 243-6590
- Tamar Yacoel, MD(972) 282-0072
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Miami Hospitals and Clinics | Miami | Florida | 33136 | Katherine Amin, MD (PRINCIPAL_INVESTIGATOR) Raveen Syan, MD (SUB_INVESTIGATOR) Tamar Yacoel, MD (SUB_INVESTIGATOR) Ricardo Palmerola, MD (SUB_INVESTIGATOR) |
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