About this trial
The objective of this study is to demonstrate the safety and efficacy of an intra-articular analgesics cocktail injection for post-operative patella fracture fixation patients, by comparing post-operative pain relief and functional recovery among study subjects who received the injection and those who did not receive the injection. Secondary objective is to demonstrate the health economic effects of intra-articular analgesics cocktail injection by reducing length of hospital stay and reducing bed-stay related complications.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
acute patella fracture requiring open reduction and internal fixation;
able to consent to surgery;
pre-morbid able to ambulate
Disqualifiers
open fracture;
polytrauma;
previous knee arthroplasty;
history of chronic pain,
Trial design
Parallel
Treatments tested in this trial
Ketorolac 15mg
DrugAn intra-articular cocktail injection ( Ketoralac 15mg, Ropivacaine 1% 15ml, 0.9% Normal Saline 35ml, Adrenaline 1:1000 0.5ml, Stacort-A Triamcinolone Acetonide 40mg) will be injected into the surgical site after fracture fixation surgery.
Triamcinolone Acetonide 40mg
DrugAn intra-articular cocktail injection ( Ketoralac 15mg, Ropivacaine 1% 15ml, 0.9% Normal Saline 35ml, Adrenaline 1:1000 0.5ml, Stacort-A Triamcinolone Acetonide 40mg) will be injected into the surgical site after fracture fixation surgery.
Ropivacaine HCL 1% 15ml
DrugAn intra-articular cocktail injection ( Ketoralac 15mg, Ropivacaine 1% 15ml, 0.9% Normal Saline 35ml, Adrenaline 1:1000 0.5ml, Stacort-A Triamcinolone Acetonide 40mg) will be injected into the surgical site after fracture fixation surgery.
0.9 % Normal Saline 35ml
DrugAn intra-articular cocktail injection ( Ketoralac 15mg, Ropivacaine 1% 15ml, 0.9% Normal Saline 35ml, Adrenaline 1:1000 0.5ml, Stacort-A Triamcinolone Acetonide 40mg) will be injected into the surgical site after fracture fixation surgery.
Adrenaline 1:1000 0.5ml
DrugAn intra-articular cocktail injection ( Ketoralac 15mg, Ropivacaine 1% 15ml, 0.9% Normal Saline 35ml, Adrenaline 1:1000 0.5ml, Stacort-A Triamcinolone Acetonide 40mg) will be injected into the surgical site after fracture fixation surgery.
Treatment groups
Trial outcomes
Primary outcomes
Pain as measured by Numerical Patient Reported Scale (NRPS)
Numerical Patient Reported Scale (NRPS), 0 (no pain) to 10 (worst pain imaginable)
Maximum Active Knee Flexion
The patient's Knee flexion is measured by a physiotherapist
Oral analgesics consumed
The level of the analgesic consumed (non-opioids, weak opioids, strong opioids), and the frequency of consumption
Tegner Lysholm Knee Score
The Lysholm Knee Score calculates and grades an overall score from 0 to 100 based on 8 domains: squatting, locking, pain, stair climbing, support, instability, and edema. Scores between 95 and 100 are regarded as exceptional, 84 and 94 as acceptable, 65 to 83 as fair, and less than 65 as poor.
Secondary outcomes
Length of hospital stay
The number of days the patient was hospitalised
Time to radiological bony union
X-rays will be taken at different follow-up intervals (post-op 2 weeks, 6 weeks, 3 months, 6 months, 12 months). The X-rays will be assessed for bony union at the surgical site.
Incidence of Complications
Complications such as fracture site infection, loss of reduction, non-union, and malunion will be assessed and recorded
Sponsors and contacts
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