WithdrawnPhase 4ACTRN12617000372381

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.


Sponsor

Orthopaedic Research Institute of Queensland (ORIQL)

Enrollment

104 participants

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria2

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

Exclusion Criteria1

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

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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 temazepa

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.


Locations(1)

Mater Hospital Pimlico - Pimlico

QLD, Australia

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ACTRN12617000372381