Preoperative Acetazolamide

NCT ID: NCT07101250

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2026-11-01

Brief Summary

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.

Detailed 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.

Conditions

Post Operative Pain; Laparoscopic Hysterectomy; Referred Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Active Drug

Acetazolamide 500mg ER

Group Type: ACTIVE_COMPARATOR

Acetazolamide 500 MG Extended Release Oral Capsule

Intervention Type: DRUG

Active Drug

Placebo

Inactive Placebo Capsule

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: DRUG

Inactive Drug

Interventions

Acetazolamide 500 MG Extended Release Oral Capsule

Active Drug

Intervention Type: DRUG

Placebo

Inactive Drug

Intervention Type: DRUG

Other Intervention Names

Diamox

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Prisma Health-Upstate

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Miller, JDMD

Role: STUDY_CHAIR

Prisma Health

Locations

Prisma Health

Greenville, South Carolina, United States

Countries

United States

Central Contacts

Patti Parker, BSN

Role: CONTACT

patti.parker@prismahealth.org

864-455-1510

Paul Miller, MD

Role: CONTACT

paul.miller@prismahealth.org

864-455-1600

Facility Contacts

Patti Parker, BSN

Role: primary

patti.parker@prismahealth.org

864-455-1510

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2310736

Identifier Type: -

Identifier Source: org_study_id