The Role of Acupuncture in Post-Operative Pain Management in Gynecological Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Morphine Equivalent Usage While in the Hospital
研究概览
简要总结
This study investigates the role of acupuncture in controlling post-operative pain in patients who have undergone gynecological surgery.
详细描述
The goal of the study is to investigate acupuncture at the time of gynecological surgery as a way to decrease post-operative pain which would decrease narcotic intake and hospitalization time. To do this, the researchers will recruit non-pregnant patients over the age of 18 who are undergoing laparoscopic surgery for a benign gynecological indication. These patients will be randomized using a computer generated randomization system to receive either acupuncture or sham acupuncture pre-operatively after the induction of anesthesia. The acupuncture points used will be points proven in the literature to be associated with decreasing general pain, pelvic pain and nausea and vomiting. The needles will be placed by a anesthesiologist trained in acupuncture and they will be left in place for 15 minutes while the patient is prepped for the surgery. The sham points will be on the hands and feet and chosen at random by the gynecologic surgeon who is not trained in acupuncture. For both groups, the acupuncture needles will be removed before the first incision of the surgery. All patients will be blinded to their group allocation.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •female patients
- •over the age of 18
- •scheduled for laparoscopic gynecological procedures for benign conditions of the uterus, fallopian tubes and/or adnexa
排除标准
- •male patients
- •pregnancy
- •suspected or known malignant disease
- •immunocompromised
- •known or persistent abuse of medications, drugs or alcohol
- •chronic pain for greater than 3 months
研究组 & 干预措施
Acupuncture
Receives acupuncture during gynecological surgery at 5 known points for pain control. Needles will be placed prior to the start of surgery by an anesthesiologist trained in acupuncture after induction of anesthesia and while the patient is prepped for surgery. They will be in place for 15 minutes.
干预措施: Acupuncture needles (Device)
Sham acupuncture
Receives acupuncture during gynecological surgery at sham points not associated with pain control. Needles will be placed by the gynecologic surgeon who is not trained in acupuncture after induction of anesthesia and prior to the start of the surgery. The needles will be removed immediately after placement.
干预措施: Acupuncture needles (Device)
结局指标
主要结局
Morphine Equivalent Usage While in the Hospital
时间窗: Intra-operative and 24 hours post-operatively
Effectiveness of intra-operative acupuncture in post-operative pain control as measured by narcotic use in the 24 hours post-operatively. Narcotic use monitored either through hospital records if patient is still admitted to the hospital or over the phone if the patient is discharged home prior to 24 hours post-operative.
次要结局
- Number of Pain Medication Tablets Used at Home Post-Operatively(7 days post-operatively)
- Number of Patients Readmitted to the Hospital(2 weeks post-operatively)
- Pain Score(up to 4 hours post operatively)
- Pain Score at Home Post-Operatively(up to 7 days post operatively)