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In patients undergoing rotator cuff repair, does the administration of temazapam, amitryptyline or pregabalin improve pain and sleep function compared to placebo.

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.

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000372381
Enrollment
104
Registered
2017-03-10
Start date
Unknown
Completion date
Unknown
Last updated
2021-03-29

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

Conditions

None listed

Brief summary

This study aims to improve sleep and pain post operatively after rotator cuff repair. It will compare three well known medications used for pain and sleep management post operative.

Interventions

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

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.

Sponsors

Orthopaedic Research Institute of Queensland (ORIQL)
Lead SponsorCharities/Societies/Foundations

Study design

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

Eligibility

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

Inclusion criteria

Older than 18 years Rotator cuff tear requiring open or arthroscopic repair

Exclusion criteria

Patients with a history of mood disorder, sleep disorder, or contraindication to temazapam, amitryptyline or pregabalin

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026