Opioid-Free Pain Control for Orthopaedic Surgery Recovery

(CORE Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: OrthoCarolina Research Institute, Inc.

Must not be taking: Anticoagulants, NSAIDs

Disqualifiers: Chronic opioid therapy, Liver disease, Alcohol dependence, Sickle cell, others

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

Compensation: Varies

Number of Visits: 6

Duration: Immediate postoperative period

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if individuals recovering from certain orthopedic surgeries can manage pain without opioids, which are strong painkillers. Researchers will compare two groups: one using opioids and another using alternative pain management methods such as Gabapentin (a nerve pain medication) and Tylenol. The trial targets individuals scheduled for surgeries like hip or shoulder replacements or specific foot surgeries. Those who regularly use opioids or have certain health issues, such as liver disease, are not eligible. The trial will evaluate the effectiveness of each pain management approach in terms of pain relief, comfort, and satisfaction. As an unphased trial, it provides a unique opportunity to contribute to research that could enhance pain management options for future 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 taking anticoagulants (blood thinners) other than aspirin, you cannot participate in the randomized part of the study, but you can join the observational control group.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that managing pain without opioids can be a safe option after surgery. Studies have found that medications like Gabapentin, Tylenol, Meloxicam, Bupivacaine, or Ketorolac work well. Patients did not experience more pain than those who used opioids.

One study found these opioid-free methods to be just as effective and safe as opioids for several common surgeries, without leading to more problems or severe pain.

All medications in the opioid-free group have FDA approval, indicating they have been checked for safety in other uses.

In summary, evidence supports that managing pain without opioids can be a safe choice, with no increase in severe pain or major side effects compared to using opioids. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about opioid-free treatments for pain control after orthopedic surgery because they eliminate the risk of addiction associated with traditional opioid medications like Hydromorphone, Hydrocodone, Tramadol, or Oxycodone. Unlike these standard opioid-based options, the opioid-free approach uses alternatives such as Gabapentin, Tylenol, Meloxicam, Bupivacaine, or Ketorolac, which are all FDA-approved and not opioids. This method aims to provide effective pain relief while minimizing side effects like drowsiness and nausea, offering a safer recovery process for patients.

What evidence suggests that this trial's treatments could be effective for pain control in orthopaedic surgery recovery?

This trial will compare opioid-based pain management with opioid-free methods for orthopedic surgery recovery. Research has shown that managing pain without opioids can be as effective as using them post-surgery. Several studies have found no major difference in pain relief between opioid and non-opioid methods in the first 24 hours after surgery. Some research even suggests that avoiding opioids might lead to better recovery and reduced future need for them. Participants in the opioid-free arm of this trial will receive medications like Gabapentin, Tylenol, and Bupivacaine, which effectively manage pain without opioid side effects. Overall, current evidence supports that managing pain without opioids can safely and effectively control post-surgical pain. ^{1 2 3 4 6}

Who Is on the Research Team?

Nady M Hamid, MD

Principal Investigator

OrthoCarolina Research Institute, Inc.

Are You a Good Fit for This Trial?

This trial is for adults needing certain orthopaedic surgeries, like spine or joint replacements, without a history of substance dependence, significant liver disease, renal insufficiency, GI bleeding/ulcers, or chronic opioid use. It excludes those on workers' comp., with alcohol dependence, taking strong anticoagulants (except aspirin), having outpatient procedures or revision surgeries.

Inclusion Criteria

You had surgery on one or two levels of your neck for degenerative disease.

You have had a knee procedure called arthroscopy to diagnose and possibly remove damaged tissue in the knee joint.

Patient is scheduled to undergo one of the following procedures:

Exclusion Criteria

Outpatient THA or TSA/RTSA

Workers compensation

You have a problem with drinking too much alcohol and are dependent on it.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgery with either an opioid-based or opioid-free pain control protocol

Immediate postoperative period

Inpatient surgical visit

Follow-up

Participants are monitored for pain and recovery outcomes at various time points post-surgery

1 year

Multiple visits at 6 hours, 12 hours, 24 hours, 2 weeks, 6 weeks, and 1 year post-surgery

What Are the Treatments Tested in This Trial?

Interventions

• Opioid-Free

Trial Overview The study compares two pain management methods after routine orthopaedic surgery: one uses opioids and the other an opioid-free approach. Patient comfort, satisfaction with surgery and recovery, pain control effectiveness and side effects like constipation and falls will be measured.

How Is the Trial Designed?

Group I: Opioid Active Control 1 Intervention

The opioid-based arm utilizes traditional, standard-of-care treatment for each applicable surgery. The medications (including dosage and frequency) used in this arm vary depending on the surgery being performed; however, tend to include medications in the opioid family such as Hydromorphone, Hydrocodone, Tramadol, or Oxycodone.

Group II: Opioid-Free Active Control 1 Intervention

The opioid-free arm utilizes medications that do not belong to the opioid family of medications. All medications used are FDA-approved and no experimental medications are being used. The medications (including dosage and frequency) used in this arm vary depending on the surgery being performed; however, tend to include medications such as Gabapentin, Tylenol, Meloxicam, Bupivacaine, or Ketorolac.

Who Is Running the Clinical Trial?

OrthoCarolina Research Institute, Inc.

Lead Sponsor

Trials

37

Recruited

6,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12351777/

Effectiveness and safety of opioid-free anesthesia compared ... No OFA regimens showed a statistically significant effect over OBA in reducing postoperative pain within the first 24 h following surgery.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2773157X24001498

Opioid-free postoperative pain management in total knee ... Most existing studies reported no significant differences in outcomes between opioid-free and opioid-based pain regimens. •. Significant heterogeneity across ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11962643/

Enhanced Recovery After Surgery (ERAS) Protocols in ... Some evidence suggests that opioid-free strategies, in some operating settings, may lead to improved recovery outcomes, reduced PO pain, and lower opioid ...

4. bmjopen.bmj.com bmjopen.bmj.com/content/10/1/e035443

Opioid versus opioid-free analgesia after surgical discharge We propose a systematic review and meta-analysis to assess the extent to which opioid analgesia impact postoperative pain intensity and adverse events

5. publishingimages.s3.amazonaws.com publishingimages.s3.amazonaws.com/eZineImages/PracticePerfect/959/An-Opioid-Free-Perioperative-Pain-Protocol-Is-Noninferior-to-Opioid-Containing-Management.pdf

An-Opioid-Free-Perioperative-Pain-Protocol-Is-Noninferior- ... The purpose of this study was to determine whether a completely opioid- free perioperative analgesia protocol could provide safe and effective pain control ...

6. academic.oup.com academic.oup.com/bjs/article/111/1/znad421/7516426

Impact of opioid-free analgesia on pain severity and patient ... The primary outcomes were patient-reported time in severe pain measured on a numerical analogue scale from 0 to 100% and patient-reported ...