Pain Management After Surgery

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05154682
• Other study ID #: AILY 21D.615
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: November 30, 2021
• Est. completion date: November 30, 2022

Study information

• Verified date: November 2021
• Source: Rothman Institute Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• OxyCODONE 5 mg Oral Tablet
Oxycodone will be given every 4 hours as needed for 2 weeks after surgery
• Acetaminophen 500Mg Tab
Acetaminophen will be taken every 4 hours for 2 weeks after surgery
• Naproxen 500 Mg
Naproxen will be taken every 12 hours for 2 weeks after surgery

Locations

Country	Name	City	State
United States	Rothman Orthopaedic Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

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