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Clinical Trials/ACTRN12615000615583
ACTRN12615000615583
Withdrawn
Phase 4

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

Monash Health0 sites60 target enrollmentStarted: June 12, 2015Last updated:

Overview

Phase
Phase 4
Status
Withdrawn
Enrollment
60

Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Randomised controlled trial
Primary Purpose
Treatment
Masking
Blinded (masking used)

Eligibility Criteria

Ages
18 Years to 80 Years (—)
Sex
Female

Inclusion Criteria

  • 1\.ASA I, II or III
  • 2\.Elective abdominal hysterectomy
  • 3\.Age \< 80

Exclusion Criteria

  • 1\.Refusal to participate
  • 2\.Unable to consent
  • 3\.Non\-English speaking background with inadequate spoken English to complete questionnaire
  • 4\.Planned pelvic exenteration or radical hysterectomy
  • 5\.Adverse drug reaction to morphine or methadone, or inability to receive a volatile anaesthetic
  • 6\.Chronic pain, or taking any regular opioid or chronic pain medication pre­operatively (paracetamol, NSAIDs, or tramadol is not an exclusion criteria)
  • 7\.History of intravenous drug use
  • 8\.Preoperative renal failure (with eGFR \< 60 mL/min), known obstructive sleep apnoea, morbid obesity (BMI \> 40 kg/m2\), or severe COAD (FEV1 \< 50% predicted)
  • 9\.Use of CYP 2B6 inducers or inhibitors: rifampicin, antiepileptics (carbamazepine, phenobarbital, phenytoin), sertraline, antiplatelets (clopidogrel, prasugrel, ticlopidine), antivirals (efavirenz, nevirapine)
  • 10\.Use of antipsychotic medication

Investigators

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