Prednisone + Glucose Monitoring for Postoperative Pain

JL
Overseen ByJacqueline Lenahan
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Columbia University
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to manage pain and other symptoms after knee or hip replacement surgery. Researchers aim to determine if taking prednisone (a type of steroid) for five days post-surgery is more effective than the usual practice of administering steroids during surgery. They will assess its impact on pain, swelling, and movement, as well as monitor its effects on blood sugar levels. Individuals undergoing knee or hip replacement surgery who have not recently used narcotics may be suitable candidates for this trial. As a Phase 4 trial, this research focuses on an FDA-approved treatment to understand its potential benefits for a broader range of patients.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've used narcotics in the past 3 months or are currently on steroid therapy.

What is the safety track record for prednisone?

Research has shown that short courses of corticosteroids like prednisone are generally safe for reducing pain after surgery. Some studies highlight that low-dose treatments, such as taking prednisone for 5 days, are effective and manageable for most people. For example, one study found that these treatments safely reduce post-surgical pain.

The likelihood of experiencing serious side effects is relatively low, though minor side effects, such as mild discomfort or temporary issues, may occur more frequently. Prednisone's approval for other conditions provides some confidence in its safety.

Overall, while prednisone is usually well-tolerated, discussing any concerns with healthcare providers is crucial before considering participation in a clinical trial.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about prednisone for postoperative pain because it offers a new approach by using a short, 5-day oral regimen. While the standard of care involves intravenous and periarticular steroid administration during surgery, prednisone's oral delivery is less invasive and more convenient for patients. Additionally, prednisone is a well-known anti-inflammatory medication that could provide rapid pain relief and reduce recovery time, potentially outperforming current methods that rely on dexamethasone and other intraoperative steroids.

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

Research has shown that low doses of corticosteroids, such as prednisone, are safe and help reduce pain after surgery. In this trial, participants in the "Post-operative Steroids" arm will receive a 5-day regimen of 40 mg oral prednisone postoperatively. One study found that higher doses of these medications slightly improved pain relief in the first 24 hours after surgery. Another study suggested that oral steroids after surgery can help with pain but might not reduce the short-term need for opioids. Overall, prednisone appears promising for managing post-surgical pain and may aid in a more comfortable recovery.12678

Are You a Good Fit for This Trial?

This trial is for adults having knee or hip replacement surgery due to arthritis or osteoarthritis. Participants should be able to take steroids and use a continuous glucose monitor after their operation.

Inclusion Criteria

I am having knee or hip replacement surgery.
I am 18 years old or older.

Exclusion Criteria

I am currently taking steroid medication.
Doesn't own smart phone
History of corticosteroid intolerance
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a 5-day regimen of 40 mg oral prednisone postoperatively or standard of care treatment with intraoperative steroids

5 days

Follow-up

Participants are monitored for pain, swelling, range of motion, opioid use, and glucose levels continuously

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Prednisone

Trial Overview

The study compares taking prednisone pills for 5 days after surgery versus the usual single steroid dose during surgery. It looks at pain, swelling, movement, opioid use, and blood sugar using continuous monitoring.

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: Post-operative SteroidsActive Control3 Interventions
Group II: Standard of carePlacebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials
1,529
Recruited
2,832,000+

Orthopaedic Scientific Research Foundation

Collaborator

Trials
1
Recruited
100+

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.

High dose glucocorticoids for treatment of postoperative pain

In most studies high dose glucocorticoids modestly improved analgesia at 24 h with subtle reductions in pain scores at rest and at motion, while no significant ...

Management of Postoperative Pain: A Clinical Practice ...

Most patients who undergo surgical procedures experience acute postoperative pain, but evidence suggests that less than half report adequate postoperative pain ...

Postoperative Pain Control - StatPearls - NCBI Bookshelf

Postoperative pain control aims to reduce the negative consequences of acute postsurgical pain and help the patient transition smoothly back to normal function.

Efficacy and safety of steroid use for postoperative pain ...

Outcomes data suggest that postoperative oral steroid may reduce postoperative pain but does not necessarily decrease short-term opioid use after lumbar ...

Corticosteroid for Postoperative Pain

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 ...

Low-Dose Steroids to Decrease Postoperative Pain and ...

Outcomes data suggest that postoperative oral steroid may reduce postoperative pain but does not necessarily decrease short-term opioid use ...

Efficacy and Safety of Steroid Use for Postoperative Pain ...

Inadequate postoperative pain relief can delay recovery, neces- sitate rehospitalization or increase the duration of the hospital.