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NCT Number: NCT07265557

Two Post-Operative Pain Protocols at Discharge for Orthopaedic Patients

This is a single-center, pilot randomized controlled trial designed to evaluate the feasibility of a definitive trial comparing opioid-free discharge prescriptions to usual care (which includes opioids) in patients undergoing major orthopaedic surgery. The main objective is to inform the design and feasibility of the definitive RCT.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mass

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

Arun Aneja, MD, PhD

CONTACT

[email protected]

617-726-6546

About this study

This is a single-center pilot RCT of at least 100 participants (20 participants from each subspecialty including trauma, arthroplasty, foot and ankle, spine, and sports) who undergo major orthopaedic surgery. Eligible and consenting patients will be randomized to either a discharge pain medication prescription without opioids or a usual care discharge pain medication (with opioids). The overarching objective of the pilot study is to inform the design and feasibility of the definitive RCT. For this pilot trial the investigators will measure feasibility against traffic light criteria based on enrollment metrics, treatment allocation adherence, and on data collection. Furthermore, this pilot RCT will compare the effectiveness of discharge pain medication without opioids to usual care discharge pain medication (with opioids) on opioid use and pain interference for patients who have undergone major orthopaedic surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients 18 years of age or older
  • Underwent a major operative orthopaedic procedure

Exclusion criteria

  • Contraindication for NSAIDs.
  • Preoperative chronic opioid use (preoperative use of >14 days and average of >30 Morphine Milligram Equivalents per day).
  • Active treatment for opioid use disorder.
  • Previous or current illicit drug use.
  • Major surgery for pathologic (cancer-related) condition.
  • Hand surgery.
  • Concurrent operative treatment by another specialty team.
  • Discharged to an extended medical care facility.
  • Incarceration.
  • Women who are pregnant or planning to become pregnant in the next 6 weeks.
  • Expected injury survival of less than 6 weeks.
  • Terminal illness with expected survival of less than 6 weeks.
  • Anticipated problems, in the judgment of research personnel, with maintaining follow-up with the patient.
  • Currently enrolled in a trial that does not permit co-enrollment.
  • Prior enrollment in the trial.
  • Unable to obtain informed consent.
  • Non-English speaking
  • Eligible patient was not approached prior to hospital discharge (missed participant).
  • Did not provide informed consent (declined participation).
  • Other reason to exclude the patient, as approved by the Principal Investigator

Treatment and study plan

Discharge pain medication prescription

Other

The patients in this pilot RCT will either receive a discharge prescription with or without opioids. The specific non-opioid medication (e.g., ibuprofen, paracetamol, ketorolac) determined by the treating physician. The dosage of the prescription including opioids is also determined by the treating physician.

Primary outcomes

  1. Feasibility of patient enrollment and treatment allocation

    Time frame: From enrollment to the end of the follow-up phase at 6 weeks

    Participant enrollment will be assessed by monitoring screening and enrollment metrics, including:

    • Participant enrollment
    • Feasibility of treatment allocation
    • Data collection methods (Proportion of participants with missing data)
    • Compliance with the protocol (Proportion of randomization errors, proportion of patients who complete each questionnaire at each of the follow-up, proportion of patients who withdraw from the trial, proportion of participants who are lost to follow-up)

Secondary outcomes

  1. Opioid Use

    Time frame: From enrollment to the end of the follow-up at 6 weeks

    Opioid usage assessed at 2 weeks and 6 weeks post-randomization

  2. Pain Interference

    Time frame: From enrollment to the end of the follow-up at 6 weeks

    Pain interference will be assessed using the Brief Pain Inventory at 2 weeks and 6 weeks from randomization.

Study contacts

Contact information is provided by the study sponsor or research team.

Arun Aneja, MD, PhD

CONTACT

[email protected]

617-726-6546

Sheila Sprague, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • McMaster University

Registry information

Official study title

A Pilot Randomized Controlled Trial Comparing Two Post-Operative Pain Protocols at Discharge for Orthopaedic Patients: A Pilot Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 5, 2025
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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