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

University of Miami

Status and phase: Enrolling; Phase 4

Conditions: Perineum; Injury; Pain Vulva; Perineal Injury

Treatments: Drug: Perineal ice packs, medicated witch-hazel pads, and topical benzocaine spray

Study type: Interventional

Funder types: Other

Identifiers

NCT07401134

20251232

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women ≥ 18 years of age
• Undergoing perineorrhaphy and/or posterior colporrhaphy (rectocele repair/posterior repair) as part of their planned vaginal pelvic reconstructive surgery
• Physically able to apply medicated witch-hazel pads (MAJOR® Medi-Pads) and administer topical benzocaine spray (Dermoplast®) to the perineal area
• Able to understand and willing to provide informed consent

Exclusion criteria

• Known allergy or hypersensitivity to any of the study products or components, including witch hazel, benzocaine, aloe, or other product ingredients
• Minors
• Presence of an indwelling catheter expected to remain in place for ≥7 days postoperatively
• History of chronic pelvic pain syndromes that may confound postoperative pain assessment, including interstitial cystitis/bladder pain syndrome (IC/BPS), endometriosis, pudendal neuralgia, or vulvodynia
• Chronic use (> 3 weeks of continuous use) of opioid pain medication
• Presence of vulvar dermatoses such as lichen sclerosus, lichen planus, or lichen simplex chronicus
• Currently pregnant or breastfeeding
• Anticipated inability to complete postoperative follow-up, including physical or cognitive limitations that would impede self-care or completion of study diaries
• Inability or unwillingness to provide informed consent or comply with study procedures

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Multimodal Perineal Analgesic Protocol (MPAP)

Experimental group

Description:

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.

Treatment:

Drug: Perineal ice packs, medicated witch-hazel pads, and topical benzocaine spray

Normal Post-Operation Care

No Intervention group

Description:

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.