Pain, Postoperative Clinical Trial
Official title:
Multi-Modal Pain Management After Outpatient Orthopaedic Surgery: A Prospective Randomized Trial
Verified date | November 2021 |
Source | Rothman Institute Orthopaedics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 200 |
Est. completion date | November 30, 2022 |
Est. primary completion date | November 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Rothman Orthopaedic Institute | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Rothman Institute Orthopaedics |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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