Intravenous Methadone for Sternotomy Pain Control in Cardiac Surgery

NCT06728371 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: CUHK_PWH
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

Background Postoperative pain is significant in cardiac surgical patients. Perioperative analgesia with intermittent administration of opioids can result in significant fluctuations in serum opioid concentrations. Methadone should provide a rapid onset and long-term pain relief upon a single intravenous dose at induction of anaesthesia, and may reduce chronic postsurgical pain (CPSP) in cardiac surgical patients. The feasibility of using intravenous methadone in Chinese cardiac surgical patients, and its effect on acute and chronic pain management after cardiac surgery will be evaluated. Methods A single-centre, prospective, randomized-controlled study. Adult cardiac surgical patients will be randomized to receive either methadone 0.2mg/kg (maximum dose 20mg) or equipotent dose of morphine at induction of anaesthesia. Patient-controlled analgesia morphine protocol, oral paracetamol and dihydrocodeine will be given for postoperative analgesia. Venous blood sampling for plasma methadone concentration will be obtained at regular intervals from study drug infusion to 96 hours after administration. The primary outcomes will be the recruitment and attrition rate, complications from methadone, and the perceived trial feasibility. Secondary outcomes include time weaned to spontaneous breathing trial, morphine consumption within 24 hours and 72 hours after surgery, time to first morphine rescue, postoperative pain score, patient satisfaction, length of stay in ICU and hospital. Side effects of opioids including sedation, nausea and vomiting, and time to first bowel opening will be recorded. CPSP will be assessed with DN4 questionnaire at 3 and 6 months after surgery.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Postoperative morphine consumption

  Morphine consumption within 72h postoperative time frame

  Postoperative within 72 hours

Secondary Outcomes (8)

• Pain score

  Within 72 hours postop

• Time to first morphine rescue

  from immediately after the operation till Day 1

• ventilator time

  from immediately after the operation till Day 1

• Nausea and vomiting

  postoperatively within 72 hours

• Length of hospital stay

  up to 1 month after surgery

Study Arms (2)

Methadone group: Intervention

EXPERIMENTAL

0.2mg/kg methadone

Drug: Methadone

Morphine group: control

ACTIVE COMPARATOR

Equipotent dose of morphine (0.2mg/kg)

Drug: Morphine

Interventions

Methadone DRUG

0.2mg/kg intravenous methadone given at induction

Also known as: Methadone: Intervention

Methadone group: Intervention

Morphine DRUG

0.2mg/kg intravenous morphine given at induction

Also known as: Morphine: control

Morphine group: control

Eligibility Criteria

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

You may qualify if:

• adult patients age 18 or older
• elective coronary artery bypass graft (CABG), valve repair/replacement, or combined CABG/valve procedure via sternotomy
• Expected extubation within 12 hours of surgery.

You may not qualify if:

• emergency surgery
• aortic surgery
• redo surgery
• preoperative renal failure requiring renal replacement therapy or creatinine clearance \<30ml/min (calculated by Cockcroft-Gault formula)
• liver dysfunction (liver enzymes twice upper limit normal)
• LVEF \<40%
• mechanical hemodynamic support in perioperative period
• history of chronic pain or who regularly used pain medications (except paracetamol and non-steroidal anti-inflammatory drugs)
• history of psychiatric illnesses or illicit drug use
• intraoperative use of remifentanil
• unable to provide informed consent.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Methadone; Morphine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Man Kin Wong

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Man Kin Wong

CONTACT

5569 9559; mkw118@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: By drawing sequentially numbered, coded sealed, opaque envelops each containing the group assignment of either methadone or morphine group. The sealed envelopes for randomization will be prepared by a third party who takes no further part in the study. The study syringes containing the drug solution will be prepared by a nurse not involved in the study with blind labelling. The primary care team, blinded to the group allocation, will perform all surgical procedures using standardized techniques. Anaesthetists and nurses blinded to group allocation will record data intraoperatively, in ICU, and at regular intervals in the cardiac wards.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single centred, parallel, double blinded, randomized controlled trial

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: December 11, 2024
• Study Start: March 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: December 11, 2024

Record last verified: 2024-12

Locations

HK (1)