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Trial registered on ANZCTR


Registration number
ACTRN12614001115628
Ethics application status
Approved
Date submitted
12/10/2014
Date registered
22/10/2014
Date last updated
22/04/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A double-blinded, randomised control trial to compare intraoperative morphine and methadone on the post-operative pain scores and analgesic requirements after shoulder arthroscopic surgery
Scientific title
In patients undergoing elective arthroscopic shoulder surgery, is a single intraoperative dose of intravenous morphine more effective than a single intraoperative dose of intravenous methadone in reducing post-operative analgesic patient-controlled-analgesia (PCA) requirements and visual analogue pain score (VAS)? A double-blinded, randomised control trial.
Secondary ID [1] 285428 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-operative pain 293187 0
Condition category
Condition code
Anaesthesiology 293461 293461 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intravenous methadone will be injected at dose of 0.15mg/kg (0.1mg/kg if age >70) after induction and before initial incision
Intervention code [1] 290353 0
Treatment: Drugs
Comparator / control treatment
Intravenous morphine will be injected at a dose of 0.15mg/kg (0.1mg/kg if age >70) after induction and before initial incision
Control group
Active

Outcomes
Primary outcome [1] 293281 0
Difference between total fentanyl PCA (patient-controlled analgesia) requirements. This is the total fentanyl requirements of participant after transfer from recovery and placed on PCA. This will be measured in micrograms.
Timepoint [1] 293281 0
Discharge home (day 1 post-operatively)
Secondary outcome [1] 310708 0
Difference between visual analogue scale scores post-operatively in recovery and 12 hours post-operatively (measuring post-operative pain)
Timepoint [1] 310708 0
In recovery and at 12 hours post-op
Secondary outcome [2] 310918 0
Difference in post-operative opiate related adverse events. This will be measured using a checklist by nursing staff who will tick whether or not the participants suffered from any of the following adverse effects:
-Post-operative nausea and vomiting
-Pruritis
-Drowsiness
-Respiratory depression
Nursing staff will also detail in the questionnaire whether the participants required treatment for any of these (including anti-emetics, anti-histamines, opioid antagonists etc)
Timepoint [2] 310918 0
Up until 1 day post-op (discharge)
Secondary outcome [3] 314280 0
Difference between recovery fentanyl usage. Participants will be prescribed a total 100 micrograms of fentanyl (4x 25micrograms) on a as required basis (PRN). Total recovery fentanyl required in recovery before transfer to ward and placed on PCA will be recorded).
Timepoint [3] 314280 0
In recovery and before transfer to ward (immediately post-operatively- hours)

Eligibility
Key inclusion criteria
Consecutive patients admitted to Nepean Private Hospital during the study period who are undergoing shoulder arthroscopy
Able to give consent for procedure
ASA I-III
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Chronic opiate use (taken opiates regularly in the month before procedure)
Opiate use in previous 48 hours
History of drug abuse
Psychiatric history
Age under 18 and over 85
Chronic renal failure (eGFR < 30mL/min/1.73m^2)
Chronic liver failure (cirrhosis/fulminant liver failure)
Weight >120kg
Allergies to study drugs (morphine/methadone)
Known contraindications to methadone (hypothyroidism, Addison’s disease, prostatic hypertrophy, urethral stricture)
Taking medications known to induce or inhibit cytochrome p450 (antifungals, macrolide antibiotics, SSRIs, antivirals)
Individuals known to be pregnant
Those who are not suitable for PCA

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)
Consecutive patients undergoing shoulder arthroscopy at Nepean Private Hospital by Dr Warren Kuo will be invited to participate in the study. They will receive a letter of invitation and patient information and consent form. If they are interested in participating in the study, the procedure and requirements will be explained to them and the consent form will be signed. Participant will be assigned a number generated from a random number table. This will be used to randomise the participant into each group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Numbers generated from a random number table will be placed into sealed, opaque envelopes by an investigator not involved with recruitment. When a participant in recruited, the investigator involved with recruitment will assign them with an envelope and hence a number. This number will be used to to randomise the participant into each group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation based on:
Retrospective audit data showing post-operative PCA fentanyl after intraoperative morphine procedures is 590 +/- 215 micrograms. Expected clinically relevant 25 percent reduction in post-operative PCA fentanyl after use of intraoperative methadone. Expected 5 patient in each group lost to follow up. Power and significance level for calculation: 0.05 (significance level), 0.80 (power).
T-test
Chi-squared

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2014
Actual
29/12/2014
Date of last participant enrolment
Anticipated
31/07/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 3033 0
Nepean Private Hospital - Kingswood
Recruitment postcode(s) [1] 8753 0
2747 - Kingswood

Funding & Sponsors
Funding source category [1] 290034 0
Self funded/Unfunded
Name [1] 290034 0
N/A
Country [1] 290034 0
Primary sponsor type
Individual
Name
Dr Edwin Khoo
Address
Nepean Private Hospital
19 Barber Ave, Kingswood NSW 2747
Country
Australia
Secondary sponsor category [1] 288725 0
None
Name [1] 288725 0
Address [1] 288725 0
Country [1] 288725 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291742 0
Nepean/Blue Mountains Health District Human Research Ethics Commitee
Ethics committee address [1] 291742 0
Ethics committee country [1] 291742 0
Australia
Date submitted for ethics approval [1] 291742 0
15/10/2014
Approval date [1] 291742 0
Ethics approval number [1] 291742 0
HREC 14/50- HREC/14/NEPEAN/101

Summary
Brief summary
To assess the perioperative analgesic requirements of single dose intraoperative, intravenous methadone versus single dose, intraoperative, intravenous morphine during shoulder arthroscopy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51822 0
Dr Edwin Khoo
Address 51822 0
Nepean Private Hospital
19Barber Ave, Kingswood NSW 2747
Country 51822 0
Australia
Phone 51822 0
+61403539788
Fax 51822 0
+6129876 8655
Email 51822 0
ejkhoo@gmail.com
Contact person for public queries
Name 51823 0
Dr Ravin Malinka Hettiarachchi
Address 51823 0
Concord Repatriation General Hospital, Hospital Road, Concord NSW 2139
Country 51823 0
Australia
Phone 51823 0
+61431574486
Fax 51823 0
Email 51823 0
ravinh@gmail.com
Contact person for scientific queries
Name 51824 0
Dr Ravin Malinka Hettiarachchi
Address 51824 0
Concord Repatriation General Hospital, Hospital Road, Concord NSW 2139
Country 51824 0
Australia
Phone 51824 0
61431574486
Fax 51824 0
Email 51824 0
ravinh@gmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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