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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

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000615583
Enrollment
60
Registered
2015-06-12
Start date
2015-06-15
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 morphine recovery protocol (equianalgesic dosing) Morphine patient-controlled analgesia postoperatively: 1mg bolus, 5-minute lockout, no limit for at least 24 hours

Sponsors

Monash Health
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

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 11. Patients with a prolonged QT interval (> 440ms) on preoperative ECG 12. Use of selective monoamine oxidase B inhibitors: selegiline, rasagiline

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026