Lower Opioid Prescriptions for Postoperative Pain

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 methods to manage pain after upper extremity surgeries while reducing opioid use. It examines whether adjusting the number of non-opioid pills or adding gabapentin, a nerve pain medication, aids recovery and alleviates pain. Participants are divided into three groups, each receiving different pain management strategies, to determine the most effective approach. Individuals who have undergone hand, wrist, or elbow surgery and lack a history of substance abuse may qualify. As a Phase 4 trial, this research aims to understand how an already FDA-approved and effective treatment can benefit more patients.

What is the safety track record for these treatments?

In a previous study, researchers found that non-opioid medications like Naproxen and Acetaminophen are generally well-tolerated for pain management. These medications reduce pain without the high addiction risk associated with opioids.

When combined with a smaller amount of Oxycodone, studies suggest that Gabapentin can enhance pain relief while reducing opioid use. However, Oxycodone remains risky and may cause serious side effects, such as breathing problems, especially in the initial days of use. Therefore, following the prescribed dosage is crucial.

Overall, the treatments in this trial have undergone prior study and are generally considered safe when used as directed. However, participants should be aware of possible side effects and discuss any concerns with the medical team conducting the trial.12345

Why are researchers enthusiastic about this trial?

Researchers are excited about these treatment regimens for postoperative pain because they aim to reduce opioid use while maintaining effective pain management. The High Pill-Count Multimodal Regimen increases the physical pill count of non-opioid meds, potentially improving adherence without increasing opioid use. Meanwhile, the Gabapentin Multimodal & Reduced Opioid Regimen introduces gabapentin to the mix, allowing for a 50% reduction in opioid prescriptions. This approach targets pain using multiple pathways, potentially decreasing the risk of opioid dependency. Unlike standard treatments that rely heavily on opioids, these regimens prioritize alternative medications and strategies, offering a promising shift in postoperative pain management.

What evidence suggests that this trial's treatments could be effective for reducing opioid dependency after upper extremity surgery?

This trial will compare different pain management regimens to reduce opioid prescriptions for postoperative pain. Research has shown that a mix of different pain medications can effectively manage pain while reducing the need for opioids. In this trial, one arm will test a High Pill-Count Multimodal Regimen, which increases the use of non-opioid medications like Naproxen and Acetaminophen. This approach may enhance patient satisfaction and lessen reliance on opioids such as Oxycodone. Another arm, the Gabapentin Multimodal & Reduced Opioid Regimen, incorporates Gabapentin, which studies suggest can cut opioid use by 30–50% in the first few days after surgery. This combination of treatments not only helps control pain but may also reduce the need for more opioid prescriptions. Overall, these methods show promise for lowering opioid dependency after surgery.678910

Are You a Good Fit for This Trial?

This trial is for people having surgery on their arm, hand, or shoulder. Participants must be able to take common pain medications and report their pain and medication use after surgery. People with certain health conditions or allergies may not qualify.

Inclusion Criteria

Able to read, write and understand English
I am at least 18 years old.
I am having surgery on my hand, wrist, or elbow.

Exclusion Criteria

I have had surgery that required staying in the hospital.
Allergy or intolerance to NSAIDS, acetaminophen, gabapentin, or narcotics
I have a history of using illicit drugs or certain prescription pain medications.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized into one of three postoperative pain medication groups and receive their assigned regimen for 7 days

7 days
In-person surgery visit

Follow-up

Participants report pain scores, medication adverse effects, and prescription refill requests during follow-up phone calls

2 weeks
2 follow-up phone calls at 3 days and 2 weeks post-surgery

Data Collection

Data on pain scores, remaining opioid pills, and adverse effects are collected

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Acetaminophen
  • Gabapentin
  • Naproxen
  • Oxycodone

Trial Overview

The study compares three different ways of managing pain after upper limb surgery: changing the number of non-opioid pills given (acetaminophen and naproxen) without changing the total daily dose, versus using gabapentin plus a much lower amount of opioid (oxycodone). Patients are randomly assigned to one group.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: High Pill-Count Multimodal RegimenExperimental Treatment3 Interventions
Group II: Gabapentin Multimodal & Reduced Opioid RegimenExperimental Treatment4 Interventions
Group III: Standard Low-Volume RegimenActive Control3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

AdventHealth

Lead Sponsor

Trials
118
Recruited
31,800+

Citations

A Comparison of Multimodal Analgesic Regimens for Opioid ...

This trial aimed to compare the efficacy of a multimodal analgesic regimen with gabapentin to a multimodal nonsteroidal anti-inflammatory ...

Gabapentin as an adjunct to multimodal pain management ...

The authors found that the addition of gabapentin improved short-term pain scores postoperatively but did not alter opioid utilization or ...

Curb Your Enthusiasm: Should Gabapentinoids Be a ...

They concluded that while preoperative dosing was marginally better than starting gabapentinoids postoperatively, the continuation of ...

Multimodal Pain Management to Reduce Opioid Use after ...

The outcomes of this study suggest that there was no statistically significant difference in postoperative analgesic treatment among acetaminophen/parecoxib and ...

5.

surgicoll.scholasticahq.com

surgicoll.scholasticahq.com/article/130902

Oral Multi-Modal Agents for Post-Operative Pain Management

Gabapentinoids play a crucial role in post-operative pain management by reducing opioid consumption by 30–50% within the first 24–48 hours.

Oxycodone - StatPearls - NCBI Bookshelf - NIH

This drug is beneficial when used judiciously for pain management, yet it carries the risk of inducing physical dependence and addiction.

Oxycodone: Uses, Dosage, Side Effects, and Warnings

Oxycodone is used to manage pain severe enough to require an opioid pain medicine when other pain medicines do not treat pain well enough, ...

Oxycodone: MedlinePlus Drug Information

Oxycodone may cause serious or life-threatening breathing problems, especially during the first 24 to 72 hours of your treatment and any time ...

Oxycodone (oral route) - Side effects & dosage

Oxycodone is used to relieve pain severe enough to require opioid treatment and when other pain medicines did not work well enough or cannot be tolerated.

Oxycodone

The effects of an overdose include: Extreme drowsiness, muscle weakness, confusion, cold and clammy skin, pinpoint pupils, shallow breathing, slow heart rate,