Pre-surgery acetazolamide to reduce shoulder pain after laparoscopic hysterectomy
Preoperative Acetazolamide for Improved Pain Control Following Laparoscopic Hysterectomy
PHASE4 · Prisma Health-Upstate · NCT07101250
This study will test whether a single preoperative dose of acetazolamide reduces shoulder and abdominal pain in women undergoing total laparoscopic hysterectomy.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 21 Years to 65 Years |
| Sex | Female |
| Sponsor | Prisma Health-Upstate (other) |
| Locations | 1 site (Greenville, South Carolina) |
| Trial ID | NCT07101250 on ClinicalTrials.gov |
What this trial studies
This randomized, placebo-controlled Phase 4 trial gives eligible women a single 500 mg extended-release oral dose of acetazolamide or a matching placebo before total laparoscopic hysterectomy for benign indications. Pain scores focused on referred shoulder pain and overall postoperative pain will be recorded before surgery and over the first 24 hours after surgery. The intervention targets peritoneal acidification from CO2 insufflation, which is thought to cause diaphragmatic irritation and referred shoulder pain. Patients with relevant exclusions (for example kidney disease, sulfonamide allergy, COPD, chronic opioid use, or pregnancy) are not enrolled, and conversions to open surgery or intraoperative injury will remove participants from analysis.
Who should consider this trial
Good fit: Women aged 21–65 scheduled for total laparoscopic hysterectomy for benign conditions who do not have excluded comorbidities or contraindications (such as kidney failure, sulfonamide allergy, COPD, chronic opioid use, or pregnancy) are ideal candidates.
Not a fit: Patients with preoperative shoulder pain, chronic pain syndromes like fibromyalgia, significant organ dysfunction, pregnancy, or those on contraindicated medications (diuretics or lithium) are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If effective, preoperative acetazolamide could reduce referred shoulder pain after laparoscopic hysterectomy, improving comfort and recovery in the immediate postoperative period.
How similar studies have performed: Prior trials have shown improved shoulder pain with preoperative acetazolamide in laparoscopic cholecystectomy, but results in pelvic/gynecologic laparoscopy have been mixed.
Eligibility criteria
Show full 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
Where this trial is running
Greenville, South Carolina
- Prisma Health — Greenville, South Carolina, United States (RECRUITING)
Study contacts
- Study coordinator: Patti Parker, BSN
- Email: patti.parker@prismahealth.org
- Phone: 864-455-1510
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Post Operative Pain, Laparoscopic Hysterectomy, Referred Pain, shoulder pain, laparoscopic, analgesia