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Intraoperative Methadone for the Prevention of Postoperative Pain

ConditionOrthopedic Surgery
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBrugmann University Hospital

About this trial

The pain felt after orthopedic surgery in the absence of adequate locoregional anesthesia is often insufficiently controlled, especially during the first 24 hours postoperatively.

Methadone, due to its long half-life, may provide better pain control after orthopedic surgery when associated locoregional anesthesia cannot be performed.

It may be impossible to perform loco-regional anesthesia in various contexts: patient refusal, pre-existing neurological impairment, infection at the injection site, coagulopathies, inability to cooperate, total language barrier, allergy to anesthetics, unavailability of equipment (ultrasound, etc.) or equipped room, lack of experience of nursing staff in performing the block and in the postoperative management of the patient.

Intraoperative administration of methadone in these settings may be superior to sufentanil for pain control during the 24 hours post orthopedic surgery, and the pain control provided by methadone does not appear to imply a higher likelihood of adverse events related to opioids.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 18 and 80 years old

ASA 1-3 status

Elective partial or total hip and knee arthroplasty

Disqualifiers

Patient refusal

Preoperative renal failure (serum creatinine > 2 mg/dL or 1.5-fold

Increase in basal plasma creatinine or GFR < 90 ml/min/1.73m2)

Significant hepatic dysfunction (PT <50% or increase in 3 times basal transaminases)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Methadone Hydrochloride

    Drug

    Classic induction of anesthesia (opioid, hypnotic and curare) but the team is blinded to the opioid used (sufentanil or methadone), which is prepared in identical syringes by the pharmacy

  • Sufentanil Citrate

    Drug

    Classic induction of anesthesia (opioid, hypnotic and curare) but the team is blinded to the opioid used (sufentanil or methadone), which is prepared in identical syringes by the pharmacy

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: S GroupActive comparator 1 intervention
Group B: M GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Total morphine consumption

Total morphine consumption

Time frame
72 hours
2

Standard visual analogue scale (VAS)

Pain is assessed using a standard visual analogue scale (VAS) in 11 points (from 0 (no pain) to 10 (worst pain))

Time frame
24 hours

Secondary outcomes

1

Patient satisfaction

Patient satisfaction is assessed by means of a questionnaire at the end of hospital stay

Time frame
72 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brugmann University Hospital

Lead sponsor

Source ClinicalTrials.gov
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