Improving Postoperative Recovery: A Randomized Study of Multimodal Perineal Analgesia Protocol (MPAP) After Vaginal Surgery
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Difference in Perineal Pain Score on Postoperative Day (POD) 3 Between Control and Interventional Groups
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Known allergy or hypersensitivity to any of the study products or components, including witch hazel, benzocaine, aloe, or other product ingredients
- •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
研究组 & 干预措施
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.
干预措施: Perineal ice packs, medicated witch-hazel pads, and topical benzocaine spray (Drug)
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.
结局指标
主要结局
Difference in Perineal Pain Score on Postoperative Day (POD) 3 Between Control and Interventional Groups
时间窗: 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.
次要结局
- Difference in Daily Pain Scores Within Post-Operative Days 0-7 Between Control and MPAP Groups(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(7 Days)
- Difference in Patient Satisfaction Scores at 2 Weeks Post-Operation Between Control and Interventional Groups(2 Weeks)
- Incidence of Adverse Events Experienced by Participants Within Post-Operative Days 0-7 Between Control and Interventional Groups(7 Days)
研究者
Katherine Amin
Assistant Professor of Clinical Urology
University of Miami