Randomized Clinical Trial of Postoperative Belladonna and Morphine Suppositories in Vaginal Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Pain at Hour 4
研究概览
简要总结
Our primary aim is to determine whether the routine use of belladonna and morphine suppositories will improve pain control following vaginal surgery. Treatment will begin immediately following surgery and every 8 hours for 16 hours.
详细描述
Minimizing postoperative pain is vital to a successful surgical recovery. Inadequate pain control may result in nausea, vomiting, an extended hospital stay, and reduced patient satisfaction. Oral and parenteral narcotics are commonly used for pain relief and their use may exacerbate the incidence of sedation, nausea, and vomiting; ultimately delaying convalescence. Previous studies have demonstrated that rectal analgesia following surgery results in lower pain scores and less intravenous morphine consumption. Belladonna and opium suppositories are routinely prescribed at our institution and their efficacy has not been confirmed.
A prospective, randomized, double-blind, placebo-controlled trial will be undertaken using belladonna and opium rectal suppositories following vaginal surgery. Treatment will begin immediately following surgery and continue every 8 hours for a total of 3 doses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Scheduled for elective vaginal surgery requiring general anesthesia at the Mayo Clinic Hospital. This would include a vaginal hysterectomy with culdoplasty or post-hysterectomy prolapse repair, including culdoplasty with or without anterior/posterior repair.
排除标准
- •Participation in another trial using an investigational product.
- •Pregnancy.
- •Scheduled for a non-vaginal surgical procedure.
- •Scheduled for a robotic hysterectomy.
- •Scheduled to have combined surgeries (vaginal surgery plus another non-vaginal surgery).
- •There is a known hypersensitivity to belladonna and/or opium.
- •Contraindication to narcotic use.
- •Chronic pain with preoperative pain score greater than 4 out of 10 points.
- •Clinically significant substance abuse.
- •Mental condition that may impair the ability to provide study assessments.
研究组 & 干预措施
Belladonna and Opium Suppositories
Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
干预措施: Belladonna and Opium Suppositories (Drug)
Placebo Suppositories
Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
干预措施: Placebo Suppositories (Drug)
结局指标
主要结局
Pain at Hour 4
时间窗: 4 hours following surgery
Pain at 4 hours was recorded using a linear analog pain scale, with 0 being "no pain," and 10 being "worst pain imaginable."
次要结局
- Number of Times Antiemetic Rescue Medication Was Used(First 24 hours after surgery)
- Number of Subjects Who Used Antiemetic Rescue Medications(First 24 hours after surgery)
- Satisfaction With Pain Relief(Approximately 24 hours following surgery)
- Narcotic Rescue Medication(For 24 hours following surgery)
- Number of Subjects With Nausea(Approximately 12 hours after surgery)
- Pain at Hour 12(12 hours after surgery.)
- Pain at Hour 20(20 hours after surgery.)
- Number of Subjects With Vomiting(Within 20 hours of surgery)
研究者
Kristina A. Butler
M.D.
Mayo Clinic