Preoperative Acetazolamide for Improved Pain Control Following Laparoscopic Hysterectomy
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Abdominal/pelvic pain and right subscapular pain rated on a VAS at five perioperative points
研究概览
简要总结
The goal of this randomized study looks at whether giving patients a medicine called acetazolamide (also called Diamox) before they have laparoscopic hysterectomy may decrease postoperative pain. Researchers will compare acetazolamide to a placebo or inactive drug, to see if acetazolamide helps the pain that may occur after surgery from the gas used in the abdomen during the laparoscopic procedure. Patients will be asked to rate their pain before surgery and after surgery through 24 hours.
详细描述
Pain control following surgery is integral to surgical success, allowing faster recovery and return to function and increasing patient satisfaction. Minimally invasive surgery, such as laparoscopy, is becoming increasingly common as it involves smaller incisions and theoretically less discomfort. However, in order to perform laparoscopy, one must insufflate the abdomen with gas in order to create space in which to operate. The most commonly used gas today is carbon dioxide, as it is highly soluble and reduces the risk of air embolism compared to room air if absorbed. A consequence of using carbon dioxide is that it is converted to carbonic acid that can be irritating to the peritoneum and specifically the diaphragm, causing referred pain to the right subscapular (shoulder) region. Multiple strategies have been undertaken to help reduce this discomfort, one of which is using acetazolamide (a carbonic anhydrase inhibitor) to help reduce peritoneal acidification. Multiple studies have demonstrated an improvement in shoulder pain following preoperative administration in laparoscopic cholecystectomy, but studies evaluating use in pelvic surgery have had mixed results. The goal of this study is to add to this understanding and determine if acetazolamide is a useful adjunct to current pain control methods in laparoscopic gynecologic surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
double blind
入排标准
- 年龄范围
- 21 Years 至 65 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Ages 21-65
- •undergoing total laparoscopic hysterectomy (TLH) for benign indications with or without bilateral salpingoophorectomy
- •undergoing total laparoscopic hysterectomy (TLH) for benign indications with or without cystoscopy
排除标准
- •Allergy to acetazolamide or sulfonamides
- •Known electrolyte disturbances
- •Pregnancy
- •Kidney failure or creatinine >1.5
- •Diuretic or lithium use
- •Chronic obstructive pulmonary disease (COPD) or other lung disease
- •Central nervous system disorders
- •Liver disease
- •Preoperative or chronic opioid use
- •Diagnosis of fibromyalgia
- •Preoperative shoulder pain
- •Conversion to laparotomy
- •Intraoperative bladder or bowel injury
- •Inability to understand or utilize visual analog scale
- •Undergoing concurrent reconstructive procedures
研究组 & 干预措施
Active Drug
Acetazolamide 500mg ER
干预措施: Acetazolamide 500 MG Extended Release Oral Capsule (Drug)
Placebo
Inactive Placebo Capsule
干预措施: Placebo (Drug)
结局指标
主要结局
Abdominal/pelvic pain and right subscapular pain rated on a VAS at five perioperative points
时间窗: From before procedure to 24 hours post procedure
Baseline score at preoperative time point and 4 time points post operative
Total analgesic use postoperatively
时间窗: from end of procedure to 24 hours post procedure
analgesic use in the post operative period will be calculated in morphine equivalents
次要结局
未报告次要终点
