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Trial registered on ANZCTR


Registration number
ACTRN12615000615583
Ethics application status
Approved
Date submitted
25/05/2015
Date registered
12/06/2015
Date last updated
25/11/2019
Date data sharing statement initially provided
25/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Postoperative Recovery After Abdominal Hysterectomy: A Randomised Clinical Trial of Methadone Compared to Morphine
Scientific title
A randomised blinded comparison of methadone to morphine in improving postoperative recovery and pain after total abdominal hysterectomy in adult women
Secondary ID [1] 286797 0
Nil
Universal Trial Number (UTN)
U1111-1170-5633
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hysterectomy 295172 0
Pain after total abdominal hysterectomy 295173 0
Postoperative Recovery 295174 0
Condition category
Condition code
Anaesthesiology 295417 295417 0 0
Pain management
Anaesthesiology 295418 295418 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 291955 0
Treatment: Drugs
Comparator / control treatment
Intravenous morphine loading after anaesthetic induction:
Age 18-50 20mg
Age 50-70 15mg
Age 70-80 10mg

Intravenous morphine titration in the postoperative recovery room as per hospital morphine recovery protocol

Morphine patient-controlled analgesia postoperatively: 1mg bolus, 5-minute lockout, no limit for at least 24 hours
Control group
Active

Outcomes
Primary outcome [1] 295153 0
Quality of Recovery score (QoR-40)
Timepoint [1] 295153 0
24 hours after surgery completion
Secondary outcome [1] 314884 0
VAS pain scores at rest
Timepoint [1] 314884 0
1, 6, 24, 48 hours postoperatively
Secondary outcome [2] 314885 0
VAS pain scores on movement
Timepoint [2] 314885 0
1, 6, 24, 48 hours postoperatively
Secondary outcome [3] 314886 0
Subjective analgesic efficacy
"How effective was your medication in relieving your pain over the last 24 h?” (excellent, good, satisfactory, poor, very poor)
Timepoint [3] 314886 0
24, 48 hours postoperatively
Secondary outcome [4] 315033 0
Opioid received in recovery room (via record from nurse)
Timepoint [4] 315033 0
At discharge from recovery room
Secondary outcome [5] 315034 0
Time to first PCA use (via PCA pump information)
Timepoint [5] 315034 0
At first PCA use
Secondary outcome [6] 315035 0
Total opioid use by patient-controlled analgesia (via PCA pump information)
Timepoint [6] 315035 0
1, 6, 24, 48 hours postoperatively
Secondary outcome [7] 315036 0
Time to discharge from hospital
Timepoint [7] 315036 0
Discharge from hospital
Secondary outcome [8] 315037 0
Chronic pain (worst NRS pain score in the last 24 hours assessed by phone interview)
Timepoint [8] 315037 0
3 months postoperatively
Secondary outcome [9] 315212 0
Nausea, vomiting, itch (0=none 1= mild 2= severe)
Timepoint [9] 315212 0
1, 6, 24, 48 hours
Secondary outcome [10] 315213 0
g. Sedation score (0=awake, alert 1=mild sedation, easy to rouse 2=moderate sedation, easy to rouse but unable to remain awake 3=difficult to rouse)
Timepoint [10] 315213 0
1, 6, 24, 48 hours
Secondary outcome [11] 315214 0
Respiratory rate (by clinical observation)
Timepoint [11] 315214 0
1, 6, 24, 48 hours
Secondary outcome [12] 315215 0
Analgesics used in the previous 24 hours (verbal response assessed by phone interview)
Timepoint [12] 315215 0
3 months postoperatively
Secondary outcome [13] 315216 0
If pain present, whether it is of new onset, or continuous since surgery, and whether pain is due to disease recurrence or surgical complications (verbal response assessed by phone interview)
Timepoint [13] 315216 0
3 months postoperatively
Secondary outcome [14] 315217 0
Pain comparator to preoperative state: less, same, or more pain compared to preoperatively (verbal response assessed by phone interview)
Timepoint [14] 315217 0
3 months postoperatively

Eligibility
Key inclusion criteria
1. ASA I, II or III
2. Elective abdominal hysterectomy
3. Age < 80
Minimum age
18 Years
Maximum age
80 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed envelope with group allocation given to non-involved person to make up study drug. Anaesthetist, patient, nursing staff all blinded to allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomised block design, stratified by incision type
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Two-sided Student’s t-tests will be used for all numerical data.
Fisher’s exact test will be used for categorical data.
Intention to treat analysis.
Missing data will not be imputed.

Sample size was calculated using published data on QoR-40 scores after abdominal hysterectomy, with a 10-point difference in QoR-40 being clinically significant (consistent with previous studies), alpha 0.05, beta 0.10.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
15/06/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 291339 0
Hospital
Name [1] 291339 0
Monash Health
Country [1] 291339 0
Australia
Primary sponsor type
Hospital
Name
Monash Health
Address
246 Clayton Road
Clayton VIC 3168
Country
Australia
Secondary sponsor category [1] 290019 0
None
Name [1] 290019 0
Address [1] 290019 0
Country [1] 290019 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292901 0
Monash Health HREC
Ethics committee address [1] 292901 0
Ethics committee country [1] 292901 0
Australia
Date submitted for ethics approval [1] 292901 0
02/06/2015
Approval date [1] 292901 0
19/06/2015
Ethics approval number [1] 292901 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57562 0
Dr Josh Szental
Address 57562 0
Department of Anaesthesia
Monash Medical Centre
246 Clayton Road
Clayton VIC 3168
Country 57562 0
Australia
Phone 57562 0
+61395943283
Fax 57562 0
Email 57562 0
jszental@gmail.com
Contact person for public queries
Name 57563 0
Josh Szental
Address 57563 0
Department of Anaesthesia
Monash Medical Centre
246 Clayton Road
Clayton VIC 3168
Country 57563 0
Australia
Phone 57563 0
+61395943283
Fax 57563 0
Email 57563 0
jszental@gmail.com
Contact person for scientific queries
Name 57564 0
Josh Szental
Address 57564 0
Department of Anaesthesia
Monash Medical Centre
246 Clayton Road
Clayton VIC 3168
Country 57564 0
Australia
Phone 57564 0
+61395943283
Fax 57564 0
Email 57564 0
jszental@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.