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Perioperative methadone compared to placebo in elderly hip fracture patients: a study protocol for a randomized controlled trial (MetaHip trial)
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Perioperative methadone compared to placebo in elderly hip fracture patients: a study protocol for a randomized controlled trial (MetaHip trial)
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Perioperative methadone compared to placebo in elderly hip fracture patients: a study protocol for a randomized controlled trial (MetaHip trial)
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Journal Article
Perioperative methadone compared to placebo in elderly hip fracture patients: a study protocol for a randomized controlled trial (MetaHip trial)
2024
Overview
Background
Hip fractures are a source of severe pain among the elderly population and pose challenges due to limited analgesic tolerance. Perioperative methadone has shown promise in our pilot study suggesting a safe dose of 0.10 mg/kg, prompting further investigation into its benefits for elderly hip fracture patients.
Methods
This study employs a double-blinded randomized controlled trial to assess the analgesic effects of a single dose of methadone during hip fracture surgery. Patients aged ≥ 60 years are consecutively enrolled and randomized to receive either perioperative methadone (treatment group) or a saline solution (placebo group). A sample size of 130 patients is required for 88% statistical power. The medication is administered intravenously at anesthesia induction and monitored until discharge. A follow-up observation is conducted 3 months post-surgery.
Discussion
Primary outcome: Daily consumption of opioids within the first 3 days after surgery. Secondary outcomes include pain, mobility, nausea, vomiting, time to discharge, need for antidote, delirium, and constipation. The 3-month follow-up includes opioid use, pain, EQ-5D-5L scores, mobility, and persistent side effects. If statistically significant advantages are found in the treatment group, perioperative methadone could be considered as standard care for hip fracture patients, potentially enhancing their pain management. The study’s outcomes will provide insights into the feasibility and effectiveness of incorporating methadone into routine clinical practices for this patient group.
Trial registration
ClinicalTrials.gov ID: NCT06086171, submitted 4. October 2023. EU-CT: 2023–506252-24–00, UTN: U1111-1294–6125.
Publisher
BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
Subject
/ Aged
/ Analgesics, Opioid - administration & dosage
/ Analgesics, Opioid - adverse effects
/ Analgesics, Opioid - therapeutic use
/ Chronic obstructive pulmonary disease
/ Consent
/ Elderly
/ Female
/ Frail
/ Humans
/ Male
/ Medicine
/ Methadone - administration & dosage
/ Morphine
/ Opioids
/ Pain
/ Pain, Postoperative - diagnosis
/ Pain, Postoperative - drug therapy
/ Pain, Postoperative - etiology
/ Patients
/ Perioperative Care - methods
/ Randomized Controlled Trials as Topic
/ RCT
/ Statistics for Life Sciences
/ Surgery
/ Trauma
/ X-rays
