WithdrawnPhase 4ACTRN12615000615583

Postoperative Recovery After Abdominal Hysterectomy: A Randomised Clinical Trial of Methadone Compared to Morphine

A randomised blinded comparison of methadone to morphine in improving postoperative recovery and pain after total abdominal hysterectomy in adult women


Sponsor

Monash Health

Enrollment

60 participants

Start Date

Jun 15, 2015

Study Type

Interventional

Conditions

Summary

The aim of this study is to compare the use of intravenous methadone to morphine in improving quality of recovery, acute pain and reducing the risk of chronic pain after abdominal hysterectomy.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 80 Yearss

Inclusion Criteria3

  • ASA I, II or III
  • Elective abdominal hysterectomy
  • Age < 80

Exclusion Criteria11

  • Refusal to participate
  • Unable to consent
  • Non-English speaking background with inadequate spoken English to complete questionnaire
  • Planned pelvic exenteration or radical hysterectomy
  • Adverse drug reaction to morphine or methadone, or inability to receive a volatile anaesthetic
  • History of intravenous drug use
  • Preoperative renal failure (with eGFR < 60 mL/min), known obstructive sleep apnoea, morbid obesity (BMI > 40 kg/m2), or severe COAD (FEV1 < 50% predicted)
  • Use of CYP 2B6 inducers or inhibitors: rifampicin, antiepileptics (carbamazepine, phenobarbital, phenytoin), sertraline, antiplatelets (clopidogrel, prasugrel, ticlopidine), antivirals (efavirenz, nevirapine)
  • Use of antipsychotic medication
  • Patients with a prolonged QT interval (> 440ms) on preoperative ECG
  • Use of selective monoamine oxidase B inhibitors: selegiline, rasagiline

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Intravenous methadone loading after anaesthetic induction: Age 18-50 20mg Age 50-70 15mg Age 70-80 10mg Intravenous methadone titration in the postoperative recovery room as per hospital morphin

Intravenous methadone loading after anaesthetic induction: Age 18-50 20mg Age 50-70 15mg Age 70-80 10mg Intravenous methadone titration in the postoperative recovery room as per hospital morphine recovery protocol (equianalgesic dosing) Morphine patient-controlled analgesia postoperatively: 1mg bolus, 5-minute lockout, no limit for at least 24 hours


Locations(1)

VIC, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12615000615583


Related Trials