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Recruiting NCT07101250

Preoperative Acetazolamide

Phase IV Interventional Post Operative Pain Laparoscopic Hysterectomy Referred Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Acetazolamide 500 MG Extended Release Oral Capsule, Placebo.
Who it may be relevant to
Registry conditions: Post Operative Pain, Laparoscopic Hysterectomy, Referred Pain. Basic parameters: 21 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Preoperative Acetazolamide for Improved Pain Control Following Laparoscopic Hysterectomy

Overview

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.

Interventions

  • Drug Acetazolamide 500 MG Extended Release Oral Capsule
    Active Drug
  • Drug Placebo
    Inactive Drug

Primary outcome measures

  • Abdominal/pelvic pain and right subscapular pain rated on a VAS at five perioperative points [Time frame: From before procedure to 24 hours post procedure]
  • Total analgesic use postoperatively [Time frame: from end of procedure to 24 hours post procedure]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Other

Study locations

United States · 1 center
  • Prisma Health — Greenville

Identifiers

NCT: NCT07101250 · 2310736

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗