Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07401134

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Perineal Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Pain Vulva Perineum; Injury Urogenital Diseases Vulvar Diseases Vulvodynia Wounds and Injuries

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Miami Hospitals and Clinics

Miami, Florida, 33136, United States

Location status: Recruiting

Location contact

Elena Cortizas

CONTACT

[email protected]

305-243-3593

Katherine Amin, MD

PRINCIPAL_INVESTIGATOR

Raveen Syan, MD

SUB_INVESTIGATOR

Ricardo Palmerola, MD

SUB_INVESTIGATOR

Tamar Yacoel, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Difference in Perineal Pain Score on Postoperative Day (POD) 3 Between Control and Interventional Groups

    Time frame: 3 Days

    Perineal Pain Score will be assessed using a 10-cm Visual Analog Scale (VAS). It consists of a 10 cm line with "no pain" at one end (0) and "worst possible pain" at the other (10). Participants will mark the line to indicate their level of pain or sensation. A higher score indicates a more severe level of pain.

Secondary outcomes

  1. Difference in Daily Pain Scores Within Post-Operative Days 0-7 Between Control and MPAP Groups

    Time frame: 7 Days

    Pain Score will be assessed using a continuous 10-cm Visual Analog Scale (VAS). It consists of a linear scale with "no pain" at one end (0) and "worst possible pain" at the other (10). To use it, the patient marks the line to indicate their level of pain or sensation. A higher score indicates a more severe level of pain. Daily VAS values will be plotted on a pain-time graph, and will be compared using a mixed-effects model for repeated measures.

  2. Difference in Total Number of Doses of Each Class of Analgesic Medications Within Post-Operative Days 0-7 Between Control and Interventional Groups

    Time frame: 7 Days

    The number of doses and class of analgesic medication (acetaminophen, NSAIDs, or opioids) will be recorded in a medication diary for control and interventional groups on post-operative days 0-7. A higher number of doses will be interpreted to higher pain burden.

  3. Difference in Patient Satisfaction Scores at 2 Weeks Post-Operation Between Control and Interventional Groups

    Time frame: 2 Weeks

    Patient satisfaction with pain management will be measured using a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied) at the 2-week postoperative visit. Median scores will be calculated for control and interventional groups. A lower value will indicate lower satisfaction while higher scores indicate higher satisfaction.

  4. Incidence of Adverse Events Experienced by Participants Within Post-Operative Days 0-7 Between Control and Interventional Groups

    Time frame: 7 Days

    Proportion of participants in each study group (control and intervention) who experience any local adverse reaction, including rash, burning, itching, or irritation, at the application site. Reactions will be recorded in participant daily diaries and/or reported during follow-up visits.

Study contacts

Contact information is provided by the study sponsor or research team.

Katherine Amin, MD

CONTACT

[email protected]

(305) 243-6590

Tamar Yacoel, MD

CONTACT

[email protected]

(972) 282-0072

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 10, 2026
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.