Perioperative Methadone in Hip Fracture Patients

NCT05581901 | Completed Phase 4

• 1 other identifier: SHS-An-2-2022
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative analgesic treatment needs to be improved. Numerous studies suggest that a single dose of Methadone given during surgery significantly ameliorates postoperative pain and reduces postoperative opioid consumption. Perioperative methadone is already used in isolated cases such as patients with chronic pain or patients with high morphine tolerance. However, it is not routinely used in the elderly and fragile, and there is insufficient reliable evidence on this treatment and population. Further investigation is highly relevant and necessary.

Conditions

Methadone; Pain, Post Operative; Pain, Postoperative; Analgesics, Opioid

Outcome Measures

Primary Outcomes (3)

• Respiratory depression

  Occurrence of a respiratory frequency \<10/min and oxygen saturation \<94 % despite 4 liters of oxygen/min.

  6 hours after surgery

• Respiratory depression

  Occurrence of a respiratory frequency \<10/min and oxygen saturation \<94 % despite 4 liters of oxygen/min.

  24 hours after surgery

• Respiratory depression

  Occurrence of a respiratory frequency \<10/min and oxygen saturation \<94 % despite 4 liters of oxygen/min.

  72 hours after surgery

Secondary Outcomes (5)

• Length of stay at the post anaesthetic care unit

  up to 12 hours after surgery

• Number of times Naloxone was administered

  immediately after the surgery (6, 24, 72 hours)

• Postoperative opioid consumption

  immediately after the surgery (6, 24, 72 hours)

• Opioid-related side-effects

  immediately after the surgery (6, 24 hours)

• Postoperative pain

  immediately after the surgery (0, 6, 24, 72 hours)

Study Arms (3)

Methadone (Dose 1)

EXPERIMENTAL

Methadone will be administered intravenously at the beginning of surgery, and will only be administered this one time. The gradual upward titration of Methadone will be managed using adaptive platform design. This way the number of patients in each group will be determined by the adaptive platform algorithm.

Drug: Methadone (Dose1)

Methadone (Dose 2)

EXPERIMENTAL

Methadone will be administered intravenously at the beginning of surgery, and will only be administered this one time. The gradual upward titration of Methadone will be managed using adaptive platform design. This way the number of patients in each group will be determined by the adaptive platform algorithm.

Drug: Methadone (Dose 2)

Methadone (Dose 3)

EXPERIMENTAL

Methadone will be administered intravenously at the beginning of surgery, and will only be administered this one time. The gradual upward titration of Methadone will be managed using adaptive platform design. This way the number of patients in each group will be determined by the adaptive platform algorithm.

Drug: Methadone (Dose 3)

Interventions

Methadone (Dose1) DRUG

Dose: 0.10mg/kg

Also known as: Dose 1

Methadone (Dose 1)

Methadone (Dose 2) DRUG

Dose: 0.15mg/kg

Also known as: Dose 2

Methadone (Dose 2)

Methadone (Dose 3) DRUG

Dose 0.20mg/kg

Also known as: Dose 3

Methadone (Dose 3)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with a hip fracture on x-rays (collum femoris fractures, pertrochanteric fractures and subtrochanteric fractures).
• Patients must be able to reliably assess their level of pain using the VRS and be able to ask for supplementary analgesics if needed.
• Patients must understand the information given and be able to read and speak Danish.
• Patients must be able to give informed consent.

You may not qualify if:

• Polytrauma (defined as a trauma with one or more absolute indications for surgical intervention).
• Previous allergic reactions or hypersensitivity towards Methadone hydrochloride or Sodium-chloride.
• Health conditions preventing treatment, i.e. chronic obstructive pulmonary disease (Gold classification C+D), history with acute asthma attacks or atopic skin conditions, cor pulmonale, raised intracranial pressure or head injury, Pheochromocytoma, history with paralytic ileus, QT interval prolongation, myasthenia gravis, liver disorders or hypotension.
• Concurrent administration with monoamine oxidase inhibitors or within 2 weeks of suspending treatment with these medicinal products.
• Concurrent administration of sedatives, e.g. Benzodiazepines or related drugs.
• Included in other studies (e.g., SENSE-trial).
• Known cognitive disorders e.g., dementia.
• Current drug addiction e.g., opioid addiction or intravenous addiction.

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (1)

Sygehus Soenderjylland

Aabenraa, 6200, Denmark

Location

Related Publications (1)

• Pedersen AK, Nygaard KH, Petersen SR, Specht K, Strom T, Moos CM, Skjot-Arkil H, Schonnemann JO. Adjusting perioperative methadone dose for elderly and fragile hip fracture patients (MetaHip-trial) - A statistical analysis plan for an adaptive dose-finding trial. Contemp Clin Trials Commun. 2023 Nov 14;36:101228. doi: 10.1016/j.conctc.2023.101228. eCollection 2023 Dec.

  PMID: 38047142 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Methadone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals

Study Officials

• Jesper Schønnemann

  Hospital of Southern Denmark - Aabenraa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: October 17, 2022
• Study Start: January 12, 2023
• Primary Completion: March 23, 2023
• Study Completion: April 4, 2023
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)