NCT07101250

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
4mo left

Started Oct 2025

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Oct 2025Nov 2026

First Submitted

Initial submission to the registry

July 25, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 3, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

October 30, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

February 20, 2026

Status Verified

July 1, 2025

Enrollment Period

9 months

First QC Date

July 25, 2025

Last Update Submit

February 18, 2026

Conditions

Post Operative PainLaparoscopic HysterectomyReferred Pain

Keywords

shoulder painlaparoscopicanalgesia

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    from end of procedure to 24 hours post procedure

Study Arms (2)

Active Drug

ACTIVE COMPARATOR

Acetazolamide 500mg ER

Drug: Acetazolamide 500 MG Extended Release Oral Capsule

Placebo

ACTIVE COMPARATOR

Inactive Placebo Capsule

Drug: Placebo

Interventions

Acetazolamide 500 MG Extended Release Oral CapsuleDRUG

Active Drug

Also known as: Diamox
Active Drug
PlaceboDRUG

Inactive Drug

Placebo

Eligibility Criteria

Age21 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsStudy of female surgery
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prisma Health

Greenville, South Carolina, 29605, United States

RECRUITING

MeSH Terms

Conditions

Pain, PostoperativePain, ReferredShoulder PainAgnosia

Interventions

Acetazolamide

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsArthralgiaJoint DiseasesMusculoskeletal DiseasesPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

ThiadiazolesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Paul Miller, JDMD

    Prisma Health

    STUDY CHAIR

Central Study Contacts

Patti Parker, BSN

CONTACT

864-455-1510patti.parker@prismahealth.org

Paul Miller, MD

CONTACT

864-455-1600paul.miller@prismahealth.org

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
double blind
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: randomized, double-blinded, controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2025

First Posted

August 3, 2025

Study Start

October 30, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

February 20, 2026

Record last verified: 2025-07

Locations

US(1)