Pain Management After Surgery

Rothman Institute Orthopaedics

Status and phase: Unknown; Phase 3

Conditions: Pain, Postoperative

Treatments: Drug: OxyCODONE 5 mg Oral Tablet; Drug: Acetaminophen 500Mg Tab; Drug: Naproxen 500 Mg

Study type: Interventional

Funder types: Other

Identifiers

NCT05154682

AILY 21D.615

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Oxycodone Group (Control Group)

Active Comparator group

Description:

Patients will receive oxycodone as needed after surgery

Treatment:

Drug: OxyCODONE 5 mg Oral Tablet

Oxycodone+ Naproxen/Acetaminophen (Study Group)

Active Comparator group

Description:

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

Treatment:

Drug: OxyCODONE 5 mg Oral Tablet

Drug: Naproxen 500 Mg

Drug: Acetaminophen 500Mg Tab