Preoperative Acetazolamide

Prisma Health-Upstate

Status and phase: Not yet enrolling; Phase 4

Conditions: Laparoscopic Hysterectomy; Referred Pain; Post Operative Pain

Treatments: Drug: Acetazolamide 500 MG Extended Release Oral Capsule; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07101250

2310736

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women
• 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

Exclusion criteria

• 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
• Glaucoma
• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Active Drug

Active Comparator group

Description:

Acetazolamide 500mg ER

Treatment:

Drug: Acetazolamide 500 MG Extended Release Oral Capsule

Placebo

Active Comparator group

Description:

Inactive Placebo Capsule

Treatment:

Drug: Placebo