Clinical Trial Finder

Preoperative Acetazolamide

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 21 Years - 65 Years
Gender Female
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT07101250
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Prisma Health-Upstate
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Paul Miller, JDMD
Principal Investigator Affiliation Prisma Health
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Post Operative Pain, Laparoscopic Hysterectomy, Referred Pain
Additional Details

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.

Arms & Interventions

Arms

Active Comparator: Active Drug

Acetazolamide 500mg ER

Active Comparator: Placebo

Inactive Placebo Capsule

Interventions

Drug: - Acetazolamide 500 MG Extended Release Oral Capsule

Active Drug

Drug: - Placebo

Inactive Drug

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Prisma Health, Greenville 4580543, South Carolina 4597040

Status

Address

Prisma Health

Greenville 4580543, South Carolina 4597040, 29605

Site Contact

Patti Parker, BSN

[email protected]

864-455-1510

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