Effects Of Intra-Operative Intra-Articular Cocktail Injection In Patella Open Reduction And Internal Fixation
NCT ID: NCT07006168
Last Updated: 2025-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
56 participants
INTERVENTIONAL
2024-11-01
2027-07-31
Brief Summary
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Detailed Description
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Patella is the largest sesamoid bone in the human body, it acts as the fulcrum of our knee extensor apparatus and is important during the gait cycle. Patella fracture commonly occurs after a fall on a flexed knee. Treatment can be conservative or surgical with open reduction and internal fixation. Patients often experience significant pain around the knee post-operatively, limiting their walking ability and hindering their rehabilitation. As a result, total hospital stay will be prolonged, leading to hospital stay-related morbidity and additional healthcare economic burden.
Previous studies have shown that the use of an analgesic cocktail injection in arthroplasty cases can significantly reduce early postoperative pain and provide better early motion. The cocktail regime is as follows for a unilateral joint:
Ketoralac 15mg Ropivacaine 1% 15ml 0.9% Normal Saline 35ml Adrenaline 1:1000 0.5ml Stacort-A Triamcinolone Acetonide 40mg Total Cocktail Volume \~50ml
After fracture fixation, patients in the intervention group will receive an intra-articular injection of the above analgesic cocktail, while patients in the control group will not receive an injection.
Herein this study, the investigators hope to demonstrate the safety and efficacy of an intra-articular analgesics cocktail injection for post-operative patella fracture fixation patients.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Intra-Articular Cocktail Injection
After fixation, an intra-articular cocktail injection is injected into the surgical site. The intra-articular cocktail regime: Ketoralac 15mg, Ropivacaine 1% 15ml, 0.9% Normal Saline 35ml, Adrenaline 1:1000 0.5ml, Stacort-A Triamcinolone Acetonide 40mg. The total cocktail volume is approximately 50ml.
Ketorolac 15mg
An 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
An 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
An 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
An 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
An 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.
No Injection
No injection will be given to the patient.
No interventions assigned to this group
Interventions
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Ketorolac 15mg
An 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
An 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
An 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
An 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
An 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.
Eligibility Criteria
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Inclusion Criteria
* able to consent to surgery;
* pre-morbid able to ambulate
Exclusion Criteria
* polytrauma;
* previous knee arthroplasty;
* history of chronic pain,
* insulin-dependent diabetes mellitus, or peptic ulcer disease;
* chronic users of glucocorticoids, immunosuppressants, or immune-modulating agents, or of strong opioids (e.g.: morphine, fentanyl, hydromorphone, methadone, oxycodone, or meperidine);
* hepatitis B or C carrier;
* renal impairment (creatinine \[Cr\], \>200 mmol/L)
18 Years
ALL
No
Sponsors
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The University of Hong Kong
OTHER
Responsible Party
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Prof. Christian Xinshuo Fang
Clinical Assistant Professor
Principal Investigators
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Christian Fang
Role: PRINCIPAL_INVESTIGATOR
Dept of Orthopaedics and Traumatology, Queen Mary Hospital
Locations
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Queen Mary Hospital, The University of Hong Kong
Hong Kong, Hong Kong, Hong Kong
Countries
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Central Contacts
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Facility Contacts
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References
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Baid M, Narula S, Manara JR, Blakeney W. Evolution in the Management of Patella Fractures. J Clin Med. 2024 Feb 29;13(5):1426. doi: 10.3390/jcm13051426.
Petrie J, Sassoon A, Langford J. Complications of patellar fracture repair: treatment and results. J Knee Surg. 2013 Oct;26(5):309-12. doi: 10.1055/s-0033-1353990. Epub 2013 Aug 16.
Other Identifiers
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UW 24-611
Identifier Type: -
Identifier Source: org_study_id
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