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Trial registered on ANZCTR


Registration number
ACTRN12617000372381
Ethics application status
Approved
Date submitted
10/07/2015
Date registered
10/03/2017
Date last updated
19/03/2021
Date data sharing statement initially provided
29/08/2019
Type of registration
N/A

Titles & IDs
Public title
In patients undergoing rotator cuff repair, does the administration of temazapam, amitryptyline or pregabalin improve pain and sleep function compared to placebo.
Scientific title
Post operative pain and sleep function in rotator cuff repair using pregabalin, amitryptyline or temazepam as an adjunct to pain management: a randomized, placebo controlled trial.
Secondary ID [1] 286432 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shoulder Rotator Cuff Tear 294601 0
Condition category
Condition code
Musculoskeletal 294902 294902 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 295818 295818 0 0
Other physical medicine / rehabilitation
Anaesthesiology 297262 297262 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a prospective, randomized, blinded and placebo controlled trial. We aim to determine if there is a significant difference and improvement when using pregabalin, amitryptyline or temazepam as an adjunct to pain management following rotator cuff repair (RCR).

Patients requiring RCR will be randomized to one of four arms of the trial:

Group one receives temazepam 10mg/20mg oral tablet, once daily in the evening (NOCTE) from day of surgery to day 14.
Group two will receive pregabalin 150mg/300mg oral tablet, once daily (NOCTE) from day of surgery to six weeks post operatively.
Group three will receive amityptyline 10mg/20mg oral tablet, once daily (NOCTE) from day of surgery to six weeks post operatively.
Group four will receive placebo, oral tablet once daily (NOCTE) from day of surgery to six weeks post operatively.

All treatment arms will follow a rule; patients under 70 years of age and over 70kg in weight will receive the larger dose . E.g. Patient #01 is 61 years old and weighs 86kg, therefore they will receive the larger dose provided for their specific treatment arm.

Upon discharge, patients will be provided with a 2 week supply of medication. The patient will be asked to bring all of their medication with them to their 2 week post-operative review appointment with the surgeon, so as to monitor adherence to the intervention.

All patients in the trial will receive the same standardized multi-modal analgesia, i.e. intra operative scalene nerve block, parental anti-inflammatory and local anesthetic medication, plus oral analgesia as required.

Patients who are identified as sleeping and coping poorly (PSQI > 5) will be considered for change of management. Placebo patients will be randomised to a treatment arm, patients in a treatment arm already will have the dosage increased if suitable or will be changed to another treatment arm.
Intervention code [1] 291510 0
Treatment: Drugs
Comparator / control treatment
Placebo (glucose tablet) duration day 1 to end of six weeks post op.
Control group
Placebo

Outcomes
Primary outcome [1] 294658 0
Sleep Function measured with PSQI
Timepoint [1] 294658 0
Pre op
Post op at two weeks, six weeks, three months and six months
Primary outcome [2] 294659 0
Shoulder function measured with Oxford Shoulder Score
Timepoint [2] 294659 0
Pre op
Post op at two weeks, six weeks, three months and six months
Secondary outcome [1] 313820 0
Neuropathic pain incidence assessed using LANSS
Timepoint [1] 313820 0
Pre op
Post op at two weeks, six weeks, three months and six months

Eligibility
Key inclusion criteria
Older than 18 years
Rotator cuff tear requiring open or arthroscopic repair
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with a history of mood disorder, sleep disorder, or contraindication to temazapam, amitryptyline or pregabalin

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)
Recruitment at surgeons rooms at time of booking for surgery.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We will generate a random sequence of numbers using an online random number generator. This sequence will be used to allocate participants to a study group. A concealed envelope system will be used to ensure surgeon, care team and patient is blinded to the treatment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Patients identified as functioning poorly will be considered for dose adjustment or change of treatment arm; this will lead to a cross-over of therapy.
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
104
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 4032 0
Mater Hospital Pimlico - Pimlico

Funding & Sponsors
Funding source category [1] 291630 0
Charities/Societies/Foundations
Name [1] 291630 0
Orthopaedic Research Institute of Queensland (ORIQL)
Country [1] 291630 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Orthopaedic Research Institute of Queensland (ORIQL)
Address
Suite 3 Level 2 Mater Medical Centre 21 - 29 Fulham Road Pimlico Queensland 4812
Country
Australia
Secondary sponsor category [1] 292030 0
None
Name [1] 292030 0
Address [1] 292030 0
Country [1] 292030 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293160 0
Mater Health Services North Queensland Human Research Ethics Committee
Ethics committee address [1] 293160 0
Ethics committee country [1] 293160 0
Australia
Date submitted for ethics approval [1] 293160 0
Approval date [1] 293160 0
13/05/2015
Ethics approval number [1] 293160 0
MHS20150512-02

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

Contacts
Principal investigator
Name 56114 0
Dr Matthew Wilkinson
Address 56114 0
Orthopaedic Research Institute of Queensland. Suite 3 Level 2 Mater Medical Centre 21 - 29 Fulham Road Pimlico Queensland 4812
Country 56114 0
Australia
Phone 56114 0
+61 747550564
Fax 56114 0
Email 56114 0
research_coordinator@oriql.com.au
Contact person for public queries
Name 56115 0
Andrea Grant
Address 56115 0
Orthopaedic Research Institute of Queensland. Suite 3 Level 2 Mater Medical Centre 21 - 29 Fulham Road Pimlico Queensland 4812
Country 56115 0
Australia
Phone 56115 0
+61 747550564
Fax 56115 0
Email 56115 0
research_coordinator@oriql.com.au
Contact person for scientific queries
Name 56116 0
Andrea Grant
Address 56116 0
Orthopaedic Research Institute of Queensland. Suite 3 Level 2 Mater Medical Centre 21 - 29 Fulham Road Pimlico Queensland 4812
Country 56116 0
Australia
Phone 56116 0
+61 747550564
Fax 56116 0
Email 56116 0
research_coordinator@oriql.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We have not yet worked out a platform on which to share the data, or the appropriate data to be shared. Our research group is currently in the in the process of coming to an agreement on this.


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.