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Clinical Trials/NCT05154682
NCT05154682
Unknown
Phase 3

Multi-Modal Pain Management After Outpatient Orthopaedic Surgery: A Prospective Randomized Trial

Rothman Institute Orthopaedics1 site in 1 country200 target enrollmentNovember 30, 2021

Overview

Phase
Phase 3
Intervention
OxyCODONE 5 mg Oral Tablet
Conditions
Pain, Postoperative
Sponsor
Rothman Institute Orthopaedics
Enrollment
200
Locations
1
Primary Endpoint
Postoperative Pain
Last Updated
4 years ago

Overview

Brief Summary

Following outpatient orthopaedic surgery, adequate pain control is imperative both for patient satisfaction and for improved recovery and rehabilitation. Opioids are frequently utilized for postoperative pain control, however they can be addictive and are known to have many deleterious effects. Recent studies have demonstrated the effectiveness of a wide variety of multi-modal postoperative pain regimens in providing adequate pain control while also decreasing opioid usage. However, the most effective multi-modal pain regimen for postoperative pain control remains unclear. This prospective, randomized study intends to investigate the efficacy of a multi-modal postoperative pain regimen compared to a traditional opioid-only pain regimen following elective outpatient orthopaedic surgery of the hand, wrist, foot, or ankle.

Registry
clinicaltrials.gov
Start Date
November 30, 2021
End Date
November 30, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age ≥ 18 years old
  • undergoing elective outpatient orthopaedic surgery under general anesthesia.

Exclusion Criteria

  • Age \< 18 years old
  • Non-English speaking
  • allergy to or medical contraindication to taking oxycodone (or other opioids), acetaminophen, or Naprosyn (or other NSAIDs).
  • currently taking opioid medications
  • history of chronic opioid therapy for chronic pain
  • surgery being performed under local anesthesia only, without general anesthesia or sedation

Arms & Interventions

Oxycodone Group (Control Group)

Patients will receive oxycodone as needed after surgery

Intervention: OxyCODONE 5 mg Oral Tablet

Oxycodone+ Naproxen/Acetaminophen (Study Group)

each patient will receive oxycodone plus acetaminophen and naproxen for 2 weeks after surgery

Intervention: OxyCODONE 5 mg Oral Tablet

Oxycodone+ Naproxen/Acetaminophen (Study Group)

each patient will receive oxycodone plus acetaminophen and naproxen for 2 weeks after surgery

Intervention: Acetaminophen 500Mg Tab

Oxycodone+ Naproxen/Acetaminophen (Study Group)

each patient will receive oxycodone plus acetaminophen and naproxen for 2 weeks after surgery

Intervention: Naproxen 500 Mg

Outcomes

Primary Outcomes

Postoperative Pain

Time Frame: 14 days

With the use of an 11 point numeric rating scale (NRS) daily satisfaction with their pain regimen, patients pain level and medication usage will be recorded.

Study Sites (1)

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