Acetazolamide for Postoperative Pain

Overseen By Paul Miller, MD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Prisma Health-Upstate

Must not be taking: Diuretics, Lithium, Opioids, others

Disqualifiers: Pregnancy, COPD, Liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if taking acetazolamide (also known as Diamox) before a laparoscopic hysterectomy can reduce post-surgery pain. During this procedure, gas is used in the abdomen, which can cause discomfort afterward. The trial will compare acetazolamide to a placebo (inactive pill) to assess which is more effective at reducing this pain. Women undergoing a laparoscopic hysterectomy for non-cancerous reasons, who do not have certain health conditions like lung disease or kidney issues, might be suitable candidates. Participants will rate their pain levels before and after surgery for 24 hours. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those using diuretics, lithium, or opioids. If you are on these medications, you may not be eligible to participate.

What is the safety track record for acetazolamide?

Research has shown that acetazolamide, also known as Diamox, has been studied for its effects on post-surgical pain. Studies suggest it can slightly aid in pain relief, especially when combined with other painkillers like bupivacaine. However, acetazolamide may cause side effects. One review found it might increase the risk of certain side effects, though the evidence for this is not very strong.

Since acetazolamide is already used for other health conditions, it indicates some level of safety. Nonetheless, it is important to be cautious and aware of possible side effects. Prospective participants should always consult healthcare providers before deciding to join a trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Acetazolamide is unique for postoperative pain management because it offers a different approach from the typical use of opioids and non-steroidal anti-inflammatory drugs (NSAIDs). Most pain treatments work by reducing inflammation or blocking pain signals, but acetazolamide operates by affecting carbonic anhydrase, an enzyme that plays a role in fluid balance and nerve signal transmission. Researchers are excited about this treatment because it has the potential to reduce the reliance on opioids, which are associated with significant side effects and addiction risks. Additionally, acetazolamide might provide pain relief without the gastrointestinal side effects commonly seen with NSAIDs.

What evidence suggests that acetazolamide might be an effective treatment for postoperative pain?

Research has shown that acetazolamide might help reduce pain after laparoscopic surgeries. In earlier studies, patients who took acetazolamide before surgery reported less pain afterwards. For instance, one study found that patients experienced lower pain levels immediately after surgery and on the first day following the procedure. Another study discovered that combining acetazolamide with another pain medicine provided better relief than using the other medicine alone. In this trial, participants will receive either acetazolamide or a placebo to evaluate its effectiveness in easing postoperative pain. Overall, strong evidence suggests that acetazolamide can help ease pain after surgery. ^{1 2 3 6 7}

Who Is on the Research Team?

Paul Miller, JDMD

Principal Investigator

Prisma Health

Are You a Good Fit for This Trial?

This trial is for individuals scheduled for laparoscopic hysterectomy who are experiencing shoulder pain, anosognosia, radiating or referred postoperative pain. Specific eligibility criteria were not provided, so participants should inquire about any additional requirements to join the study.

Inclusion Criteria

I am a woman aged 21-65 planning to have a laparoscopic hysterectomy for non-cancer reasons.

I am a woman aged 21-65 planning to have a laparoscopic hysterectomy for non-cancerous reasons.

Exclusion Criteria

I have COPD or another lung condition.

I have shoulder pain before surgery.

Allergy to acetazolamide or sulfonamides

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Preoperative

Participants receive acetazolamide or placebo before laparoscopic hysterectomy

1 day

1 visit (in-person)

Postoperative Monitoring

Participants' pain levels and analgesic use are monitored for 24 hours after surgery

24 hours

Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Acetazolamide

Trial Overview The study tests if taking Acetazolamide (Diamox) before surgery can reduce post-surgery pain compared to a placebo. It's a randomized trial where patients rate their pain levels before and up to 24 hours after the procedure.

How Is the Trial Designed?

Group I: Active Drug Active Control 1 Intervention

Acetazolamide 500mg ER

Group II: Placebo Active Control 1 Intervention

Inactive Placebo Capsule

Who Is Running the Clinical Trial?

Prisma Health-Upstate

Lead Sponsor

Trials

91

Recruited

47,500+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9385114/

Systematic Review and Meta-Analysis of Perioperative ... Current available evidence demonstrates that perioperative ACTZ may provide a modest improvement in postoperative referred pain following LSC.

2. digitalscholar.lsuhsc.edu digitalscholar.lsuhsc.edu/cgi/viewcontent.cgi?article=1200&context=sommrd

Systematic Review and Meta-Analysis of Perioperative ... Postoperative pain intensity using VAS Acetazolamide + bupivacaine group had reduced postoperative pain scores compared to bupivacaine only group. Pourladian ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0090429522009876

Impact of Acetazolamide on Perioperative Pain Control in ... Prior studies have demonstrated that preoperative acetazolamide decreased postoperative referred pain in the postsurgical period for laparoscopic procedures.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26487218/

Acetazolamide Reduces Postoperative Pain Following ... Specifically, patients who received acetazolamide reported lower pain scores immediately after surgery (0.6 ± 1.2 vs 1.9 ± 2.3, p = 0.01) and on post-op day one ...

5. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/50/NCT07101250/Prot_SAP_000.pdf

Preoperative Acetazolamide for Improved Pain Control ... Outcome Measures/Data. List all outcome measures/data that will be ... administration of acetazolamide for management of postoperative pain after ...

6. trials.arthritis.org trials.arthritis.org/trials/NCT07101250

Preoperative Acetazolamide - Clinical Trial Finder 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 ...

7. bmjopenrespres.bmj.com bmjopenrespres.bmj.com/content/7/1/e000557

Side effects of acetazolamide: a systematic review and ... AZM increased the risk of all primary outcomes (p<0.01, I2 ≤16% and low-to-moderate quality of evidence for all)—the numbers needed to harm (95% ...