None listed
Conditions
Brief summary
This study is designed to assess whether Pregabalin is an effective pain medication for patients recovering from shoulder surgery. Pregabalin is a type of medication proven to be effective at treating certain types of pain and it is currently being used by many shoulder surgeons for their patients, however, there is yet to be any published scientific proof that Pregabalin is effective in these patients. This study aims to determine whether this medication is effective for these patients and reduces their overall pain during the period from 5 days before their operation to two weeks after their operation.
Interventions
75 mg of oral Pregabalin will be self-administered twice daily commencing 5 days before the participant's operation and continuing for 15 days after the operation including operation day. The trial participant receives a total of 42 doses of 75 mg Pregabalin over a total 21 days.
The Pregabalin will be delivered via the oral route in the form of a tablet (size and colour matched placebo will be used). Adherence to the dosing scheme will be monitored via Participant Diaries. These diaries will b
75 mg of oral Pregabalin will be self-administered twice daily commencing 5 days before the participant's operation and continuing for 15 days after the operation including operation day. The trial participant receives a total of 42 doses of 75 mg Pregabalin over a total 21 days. The Pregabalin will be delivered via the oral route in the form of a tablet (size and colour matched placebo will be used). Adherence to the dosing scheme will be monitored via Participant Diaries. These diaries will be checked at all visits (pre-op, operative, post-op). Adherence to the dosing scheme will also be monitored via a 'calling plan.' Participants will be called 6, 3 and 1 day before their operation to check they are taking their medication appropriately. They will also be called 4, 8 and 12 days after their operation for the same reason. This plan helps to avoid the circumstance of an individual being excluded from the results due to poor compliance. A participant will be considered non compliant if they miss a total of 8 doses or if they miss 4 consecutive doses.
Sponsors
Epworth HealthCare
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
35 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Patients are eligible to be included in the trial only if they meet all of the following criteria: [1] Present with a need for rotator cuff repair (for cuff tears diagnosed by ultra-sound or MRI scan) and/or subacromial decompression for impingement syndrome. [2] Are aged between 35 and 75 years. [3] Have an educational level and degree of understanding such that they can communicate intelligibly with the investigator and other trial personnel. [4] Are judged to be reliable and agree to keep all appointments for clinic visits, tests and procedures required by the protocol. [5] Are capable of giving informed consent.
Exclusion criteria
Exclusion Criteria Patients will be excluded from the trial if they meet any of the following criteria: [1] Are investigator site personnel directly affiliated with this trial and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. It will be the responsibility of the recruiting surgeon to gather this information and will obviously require trial participants cooperation. [2] Are Epworth HealthCare employees. [3] Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this trial. [4] Are unwilling or unable to comply with the use of a data collection device to directly record data from the subject. [5] Have massive, irreparable cuff tears. This will be a clinical decision made by the treating surgeon. [6] Have peripheral neuropathy affecting the upper limbs. [7] Chronic opiate use (defined as longer than 3 months use). [8] Are pregnant, or are attempting to conceive. [9] Have a diagnosed mental illness and are taking medication which may interfere with the trial. [10] Are taking any anticonvulsant/anti-epileptic medication or have been diagnosed with epilepsy. [11] Have a cognitive impairment, eg dementia. [12] Inability to give informed consent.
Outcome results
None listed