Corticosteroid for Postoperative Pain

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Mayo Clinic

Must not be taking: Opioids, Corticosteroids

Disqualifiers: Chronic pain, Pregnancy, Diabetes, others

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

Compensation: Varies

Number of Visits: 1

Duration: 3 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding prednisone, a corticosteroid (a type of anti-inflammatory drug), to the usual pain medications can reduce pain after ureteroscopy. Ureteroscopy treats kidney or ureteral stones and involves placing a small tube (stent) in the urinary tract. Participants will receive either the standard pain treatment plus prednisone or the standard pain treatment with a placebo (a harmless pill). Those diagnosed with kidney or ureteral stones and planning to undergo this procedure might be suitable if they don't have a history of chronic pain or certain other conditions. As a Phase 4 trial, this research involves an FDA-approved treatment and seeks to understand its benefits for 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 you cannot participate if you are currently using corticosteroids or have a history of chronic pain medication use.

What is the safety track record for this treatment?

Research has shown that corticosteroids, such as prednisone, are generally safe to use after surgery. One study found that taking a low dose of these medications does not increase the risk of infections at the surgery site, indicating they are well-tolerated (source 2). Another study found that corticosteroids can help reduce pain in the week following surgery (source 4).

This trial's later phase indicates strong evidence already supports the safety of corticosteroids in humans. While minor side effects can occur, this phase suggests that serious problems are unlikely for most people. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using corticosteroids like prednisone for postoperative pain because they offer a unique approach compared to standard pain management options. While typical treatments rely on opioids and NSAIDs to reduce pain and inflammation, corticosteroids work by suppressing the immune response, potentially reducing inflammation more effectively. This could lead to quicker pain relief and reduced reliance on opioids, which are known for their addictive properties. Additionally, prednisone is administered orally, making it convenient for patients to take post-surgery.

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

Research shows that medications like prednisone, a corticosteroid, help reduce pain after surgery. In this trial, one group of participants will receive standard postoperative care plus prednisone 25 mg. Studies have found that low doses of these medications for a short time can safely lessen pain. Prednisone, specifically, can significantly reduce pain within 4 to 6 hours after surgery. This treatment may also reduce the need for additional pain medication and lower the risk of nausea or vomiting after surgery. Overall, corticosteroids are a helpful addition to standard pain management after various surgeries. ^{3 5 6 7 8}

Who Is on the Research Team?

Karen L. Stern, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals who have undergone ureteroscopy, a procedure to remove kidney stones, and are experiencing postoperative pain. Participants should be in need of pain management after the surgery.

Inclusion Criteria

Patients of all ethnic backgrounds

I have kidney or ureteral stones confirmed by CT scan and will undergo ureteroscopy with stent placement.

I am 18 years old or older.

Exclusion Criteria

Chronic use of opioids or other pain medication (>12 weeks)

Known allergies to corticosteroids

Known or suspected pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive standard postoperative ureteroscopy medication with either prednisone or placebo

3 days

Daily monitoring (in-person or virtual)

Follow-up

Participants are monitored for pain levels and medication usage post-treatment

1 week

1 visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Corticosteroid

Trial Overview The study is testing whether taking corticosteroids (specifically prednisone) can help manage pain better than usual care after ureteroscopy when patients also receive a stent. Some will get the steroid; others will get a placebo without knowing which one they received.

How Is the Trial Designed?

Group I: Standard of care plus Corticosteroid Experimental Treatment 1 Intervention

Participants will receive standard of care postoperative ureteroscopy medication, with the addition of prednisone 25 mg.

Group II: Standard of Care Placebo Group 1 Intervention

Participants will receive standard of care postoperative ureteroscopy medication, with the addition of a placebo pill.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/16757774/

Efficacy and safety of steroid use for postoperative pain ... The results of randomized trials have shown low, short-dose corticosteroid regimens to be safe and effective for reducing postoperative pain.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0952818023003033

High dose glucocorticoids for treatment of postoperative pain Secondary outcomes were postoperative pain 0–100 mm VAS score 48 h after surgery, postoperative rescue analgesic requirement, postoperative nausea and vomiting ...

3. dupuytrens.org dupuytrens.org/DupPDFs/2006_Salerno.pdf

Efficacy and Safety of Steroid Use for Postoperative Pain ... More recently, Gilron27 concluded that the current evidence suggests that systemic corticoster- oids are efficacious in the treatment of postoperative pain, ...

4. journals.lww.com journals.lww.com/senj/fulltext/2023/13030/efficacy_of_corticosteroids_on_postoperative_pain.1.aspx

Efficacy of corticosteroids on postoperative pain levels after ... Analysis by type of corticosteroids showed that prednisolone significantly decreased postoperative pain at 4–6 h in three of the studies (P = 0.009). Moreover, ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28851016/

Effect of Intravenous Corticosteroids on Pain Management ... Conclusion: Our results show that intravenous corticosteroids have good efficacy and safety when used perioperatively in total knee or hip arthroplasty.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07223580

A Study Of Corticosteroid On Postoperative Pain After ... A phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11607708/

Effects of Postoperative Oral Corticosteroids on Infection ... We propose that a 6-day regimen of low-dose postoperative oral corticosteroids is safe and does not increase the likelihood of surgical site infections (SSIs) ...

8. link.springer.com link.springer.com/article/10.1007/s44337-025-00368-9

Evaluating the impact of surgical technique and ... With a sample of 46 patients, the data demonstrated a significant reduction in pain scores over the first postoperative week, as expected.