Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 12:39 AM
NCT ID:
NCT01560767
Eligibility Criteria:
Inclusion Criteria:
* All patients undergoing an elective primary unilateral total knee arthroplasty (TKA) under the care of an orthopaedic consultant at University Hospitals Coventry and Warwickshire NHS trust are potentially eligible for the trial.
Exclusion Criteria:
* Those with sufficient cognitive impairment that they would be unable complete questionnaire (cognitive impairment).
* Those patients who lack capacity under the Mental Capacity Act 2005
* Those patients with a pre-operative history of neurological abnormality in the ipsilateral leg e.g. history of stroke, neurogenic pain or previous nerve injury.
* Those patients having spinal anaesthesia.
* Those patients with a specific contraindication to the analgesic agents used:Morphine: Hypersensitivity reaction Ketorolac: Active or previous peptic ulcer. History of upper gastrointestinal bleeding or perforation, related to previous NSAID therapy.
* Haemorrhagic diatheses, including coagulation disorders
* Hypersensitivity to ketorolac trometamol or other NSAIDs
* Moderate or severe renal impairment (serum creatinine \> 160 micromol/l)
* Levobupivicaine: Levobupivacaine solutions are contra-indicated in patients with a known hypersensitivity to levobupivacaine, local anaesthetics of the amide type or any of the excipients
* Uncontrolled angina
* 2nd/ 3rd degree heart block
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01560767
Study Brief:
Protocol Section:
NCT01560767