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Recruiting NCT07006168

Effects Of Intra-Operative Intra-Articular Cocktail Injection In Patella Open Reduction And Internal Fixation

Phase IV Interventional Patella Fracture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ketorolac 15mg, Triamcinolone Acetonide 40mg, Ropivacaine HCL 1% 15ml, 0.9 % Normal Saline 35ml.
Who it may be relevant to
Registry conditions: Patella Fracture. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effects Of Intra-Operative Intra-Articular Cocktail Injection In Patella Open Reduction And Internal Fixation (ORIF): A Single Centre, Double Blinded, Randomised Control Trial

Overview

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.

Detailed description

This is a single-centre, double-blinded, randomised control trial that evaluates the efficacy of intra-articular analgesics cocktail injection in post-operative pain relief and functional recovery for fractured patella fixation patients. The recruited study subjects will be randomised to the two study groups respectively in a 1:1 randomisation ratio.

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.

Interventions

  • Drug 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.
  • Drug 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.
  • Drug 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.
  • Drug 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.
  • Drug 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.

Primary outcome measures

  • Pain as measured by Numerical Patient Reported Scale (NRPS) [Time frame: Pre-op, Post-op Day 1 to 3]
  • Maximum Active Knee Flexion [Time frame: At post-op Day 1 to 3]
  • Oral analgesics consumed [Time frame: Post-operative 2 weeks period]
  • Tegner Lysholm Knee Score [Time frame: Post-op Day 14]
  • Knee Injury and Osteoarthritis Outcome Score (KOOS) [Time frame: Post-op Day 14]
  • 9-item Quality of Recovery Score (QoR-9 Score) [Time frame: Post-op Day 1 to 3]
Secondary outcome measures (3)
  • Length of hospital stay [Time frame: Through study completion, an average of 1 year]
  • Time to radiological bony union [Time frame: Through study completion, an average of 1 year]
  • Incidence of Complications [Time frame: Through study completion, an average of 1 year]

Eligibility criteria

Inclusion criteria

  • acute patella fracture requiring open reduction and internal fixation;
  • able to consent to surgery;
  • pre-morbid able to ambulate

Exclusion criteria

  • open fracture;
  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • Queen Mary Hospital, The University of Hong Kong — Hong Kong

Publications

  • 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. PMID 38592262
  • 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. PMID 23955187

Identifiers

NCT: NCT07006168 · UW 24-611

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗