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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multimodal Perineal Analgesic Protocol (MPAP) | Experimental | 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:
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. |
|
| Normal Post-Operation Care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Perineal Pain Score on Postoperative Day (POD) 3 Between Control and Interventional Groups | 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. | 3 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Daily Pain Scores Within Post-Operative Days 0-7 Between Control and MPAP Groups | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katherine Amin, MD | Contact | (305) 243-6590 | katherine.amin@med.miami.edu | |
| Tamar Yacoel, MD | Contact | (972) 282-0072 | t.yacoel@umiami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Katherine Amin, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Hospitals and Clinics | Recruiting | Miami | Florida | 33136 | United States |
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|
| 7 Days |
| Difference in Total Number of Doses of Each Class of Analgesic Medications Within Post-Operative Days 0-7 Between Control and Interventional Groups | 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. | 7 Days |
| Difference in Patient Satisfaction Scores at 2 Weeks Post-Operation Between Control and Interventional Groups | 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. | 2 Weeks |
| Incidence of Adverse Events Experienced by Participants Within Post-Operative Days 0-7 Between Control and Interventional Groups | 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. | 7 Days |
| ID | Term |
|---|---|
| D056650 | Vulvodynia |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D014845 | Vulvar Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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