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临床试验/NCT07101250
NCT07101250招募中4 期

Preoperative Acetazolamide for Improved Pain Control Following Laparoscopic Hysterectomy

Prisma Health-Upstate1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年10月30日最近更新:
干预措施
相关药物

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

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

Active Comparator

Acetazolamide 500mg ER

干预措施: Acetazolamide 500 MG Extended Release Oral Capsule (Drug)

Placebo

Active Comparator

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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