Pain Management After Surgery
Multi-Modal Pain Management After Outpatient Orthopaedic Surgery: A Prospective Randomized Trial
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2021
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2021
CompletedStudy Start
First participant enrolled
November 30, 2021
CompletedFirst Posted
Study publicly available on registry
December 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2022
CompletedDecember 13, 2021
November 1, 2021
1 year
November 30, 2021
November 30, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Postoperative Pain
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.
14 days
Study Arms (2)
Oxycodone Group (Control Group)
ACTIVE COMPARATORPatients will receive oxycodone as needed after surgery
Oxycodone+ Naproxen/Acetaminophen (Study Group)
ACTIVE COMPARATOReach patient will receive oxycodone plus acetaminophen and naproxen for 2 weeks after surgery
Interventions
Oxycodone will be given every 4 hours as needed for 2 weeks after surgery
Acetaminophen will be taken every 4 hours for 2 weeks after surgery
Naproxen will be taken every 12 hours for 2 weeks after surgery
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years old
- undergoing elective outpatient orthopaedic surgery under general anesthesia.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2021
First Posted
December 13, 2021
Study Start
November 30, 2021
Primary Completion
November 30, 2022
Study Completion
November 30, 2022
Last Updated
December 13, 2021
Record last verified: 2021-11