Two Post-Operative Pain Protocols at Discharge for Orthopaedic Patients

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Discharge pain medication prescription
  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.

Первичные конечные точки

• Feasibility of patient enrollment and treatment allocation [Срок оценки: From enrollment to the end of the follow-up phase at 6 weeks]

Вторичные конечные точки (2)

• Opioid Use [Срок оценки: From enrollment to the end of the follow-up at 6 weeks]
• Pain Interference [Срок оценки: From enrollment to the end of the follow-up at 6 weeks]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• Mass — Boston

Идентификаторы

NCT: NCT07265557 · 2025P002285

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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