Post Operative PainPhase 4NCT07101250
Preoperative Acetazolamide
A Phase 4 study testing Acetazolamide 500 MG Extended Release Oral Capsule in people with Post Operative Pain and Laparoscopic Hysterectomy, run by Prisma Health-Upstate at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years, women only
- Conditions the study is for
- Post Operative Pain, Laparoscopic Hysterectomy, Referred Pain
- What is being tested?
- Acetazolamide 500 MG Extended Release Oral Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2025to 1 Dec 2026
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Prisma Health
Greenville, South Carolina, 29605
Patti Parker, BSN, 864-455-1510, patti.parker@prismahealth.org
About this study
Official title: Preoperative Acetazolamide for Improved Pain Control Following Laparoscopic Hysterectomy
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.
Read the 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.
- Being tested
- Acetazolamide 500 MG Extended Release Oral Capsule, Placebo
- Keywords
- shoulder pain, laparoscopic, analgesia
- Medical subject headings
- Pain, Postoperative, Pain, Referred, Shoulder Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetazolamide 500 MG Extended Release Oral CapsuleDrug
Also called Diamox
Active Drug
PlaceboDrug
Inactive Drug
| Study group | Role | What they receive |
|---|---|---|
| Active Drug | Active comparator | Acetazolamide 500mg ER Receives: Drug: Acetazolamide 500 MG Extended Release Oral Capsule |
| Placebo | Active comparator | Inactive Placebo Capsule Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal/pelvic pain and right subscapular pain rated on a VAS at five perioperative points
Baseline score at preoperative time point and 4 time points post operative
Measured: From before procedure to 24 hours post procedure
Total analgesic use postoperatively
analgesic use in the post operative period will be calculated in morphine equivalents
Measured: from end of procedure to 24 hours post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start30 Oct 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, double-blinded, controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Miller, JDMD, Study chair, Prisma Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07101250
- Sponsor's protocol ID
- 2310736
- Status last verified
- Oct 2026
- First submitted
- 25 Jul 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided