Pain Management After Surgery

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05154682

Enrollment

200

Registered

2021-12-13

Start date

2021-11-30

Completion date

2022-11-30

Last updated

2021-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

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.

Interventions

DRUGOxyCODONE 5 mg Oral Tablet

Oxycodone will be given every 4 hours as needed for 2 weeks after surgery

DRUGAcetaminophen 500Mg Tab

Acetaminophen will be taken every 4 hours for 2 weeks after surgery

DRUGNaproxen 500 Mg

Naproxen will be taken every 12 hours for 2 weeks after surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026