Pain Management After Surgery

Phase 3

• Conditions: Pain, Postoperative
• Interventions: Drug: OxyCODONE 5 mg Oral Tablet; Drug: Acetaminophen 500Mg Tab; Drug: Naproxen 500 Mg

• Registration Number: NCT05154682
• Lead Sponsor: Rothman Institute Orthopaedics

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-11
• Study Start: 2021-11-30
• Study First Submitted: 2021-11-30
• Study First Submitted QC: 2021-11-30
• Last Update Submitted: 2021-11-30
• Study First Posted: 2021-12-13
• Last Update Posted: 2021-12-13
• Primary Completion: 2022-11-30
• Study Completion: 2022-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxycodone+ Naproxen/Acetaminophen (Study Group)	Acetaminophen 500Mg Tab	each patient will receive oxycodone plus acetaminophen and naproxen for 2 weeks after surgery
Oxycodone+ Naproxen/Acetaminophen (Study Group)	OxyCODONE 5 mg Oral Tablet	each patient will receive oxycodone plus acetaminophen and naproxen for 2 weeks after surgery
Oxycodone+ Naproxen/Acetaminophen (Study Group)	Naproxen 500 Mg	each patient will receive oxycodone plus acetaminophen and naproxen for 2 weeks after surgery
Oxycodone Group (Control Group)	OxyCODONE 5 mg Oral Tablet	Patients will receive oxycodone as needed after surgery

Primary Outcome Measures

Name	Time	Method
Postoperative Pain	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.

Trial Locations

Locations (1)

Rothman Orthopaedic Institute; 🇺🇸 Philadelphia, Pennsylvania, United States