100 Participants Needed

Pain Management for Post-Operative Pain

AA
SS
Overseen BySheila Sprague, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
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 new methods to manage pain after major orthopedic surgery without opioids. It compares the usual care discharge prescriptions, which include opioids, with an experimental approach using only non-opioid painkillers like ibuprofen or paracetamol (opioid-free discharge prescriptions). The goal is to determine if patients can recover comfortably without opioids. Individuals who have undergone major orthopedic surgery and do not regularly use opioids might be suitable candidates for this trial. As a Phase 4 trial, the treatment has already received FDA approval and proven effective, and this research aims to understand how it can benefit more patients.

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

The trial information does not specify if you need to stop taking your current medications. However, if you are using opioids regularly before surgery, you may not be eligible to participate.

What is the safety track record for these treatments?

Research has shown that avoiding opioids for post-surgery pain relief can be safe. A review found that opioids do not effectively reduce post-surgery pain and increase the risk of unwanted side effects. Non-opioid painkillers, such as ibuprofen or paracetamol, might be gentler on the body.

Further studies on avoiding opioids have demonstrated positive outcomes. Patients using non-opioid pain relief often experience fewer side effects, suggesting that non-opioid treatments are generally well-tolerated.

In summary, evidence supports the safety of avoiding opioids after surgery, as these treatments typically cause fewer side effects than opioids.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about opioid-free discharge prescriptions for post-operative pain management because they offer a way to control pain without the risk of addiction associated with opioids. Unlike usual care prescriptions that often include opioids like oxycodone or hydrocodone, this approach relies on non-opioid analgesics such as ibuprofen, paracetamol, or ketorolac. These medications work by reducing inflammation and blocking pain signals, providing effective pain relief while minimizing the potential for side effects and dependency. This makes the opioid-free option an appealing alternative for ensuring patient safety and comfort after surgery.

What evidence suggests that this trial's treatments could be effective for post-operative pain management?

This trial will compare opioid-free discharge prescriptions with usual care discharge prescriptions that include opioids. Research has shown that managing pain without opioids can be effective after surgery. Studies have found that non-opioid medications, such as ibuprofen and acetaminophen, do not increase pain on the first day after leaving the hospital compared to opioids. A review of research found that using non-opioid pain relievers can reduce the need for opioids post-surgery. Another study demonstrated that non-opioid treatments can effectively control pain, lowering opioid use without worsening pain. Overall, this evidence suggests that prescriptions without opioids could effectively manage pain after surgery.12678

Who Is on the Research Team?

AA

Arun Aneja, MD PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for patients who have undergone major orthopaedic surgery and are experiencing post-operative pain. It's designed to see if opioid-free prescriptions at discharge can work as well as usual care, which includes opioids.

Inclusion Criteria

Patients 18 years of age or older
I have had major orthopedic surgery.

Exclusion Criteria

Anticipated problems, in the judgment of research personnel, with maintaining follow-up with the patient
Currently enrolled in a trial that does not permit co-enrollment
Prior enrollment in the trial
See 17 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either opioid-free or usual care discharge pain medication

Immediate post-surgery

Follow-up

Participants are monitored for opioid use and pain interference

6 weeks
Assessments at 2 weeks and 6 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Opioid-Free Discharge Prescriptions
  • Usual Care Discharge Prescriptions
Trial Overview The study compares two types of pain management protocols after surgery: one group will receive opioid-free prescriptions upon discharge, while the other will follow the standard practice that includes opioids.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Discharge pain medication prescription without opioidsExperimental Treatment1 Intervention
Group II: Usual care discharge prescription (with opioids)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

McMaster University

Collaborator

Trials
936
Recruited
2,630,000+

Citations

a systematic review and meta-analysis of randomised trialsCompared with opioid-free analgesia, opioid prescribing did not reduce pain on the first day after discharge (weighted mean difference 0·01cm, 95% CI –0·26 to 0 ...
Postoperative Analgesia Intervention With Non-opioid ...If opioid-free analgesia is found to be effective, doctors may be able to substantially reduce opioid prescribing after breast surgery and prevent more people ...
Efficacy of nonopioid analgesics and adjuvants in ...This systematic review and network meta-analysis shows that nonopioid iv analgesics and adjuvants reduce postoperative opioid consumption in patients with ...
Opioid versus opioid-free analgesia after surgical dischargeAs this meta-analysis is focussed on acute pain management after surgery, we will target outcome data collected up to 30 days postoperatively (from the day when ...
Opioid-Free Discharge After Pancreatic ResectionThis cohort study analyzes the outcomes of iterative risk-stratified clinical pathways associated with inpatient and discharge opioid ...
Opioid-free strategies for patient-controlled intravenous ...This article systematically reviews the progress of research on opioid-free analgesic strategies in PCIA through a comprehensive analysis of relevant ...
Epidemiology of Opioid Prescribing After Discharge From ...Guidelines are needed to best align opioid prescribing with patient need and require data centered on patient-reported outcomes and experience ...
American Society for Enhanced Recovery and Perioperative ...Prescribing opioids at hospital discharge to previously opioid-naive patients is a risk factor for chronic opioid use 1 year after discharge. Educating ...
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