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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Hong Kong

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Ketorolac 15mg

    Drug

    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

    Drug

    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

    Drug

    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

    Drug

    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

    Drug

    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.

Treatment groups

56 Participants
are divided into 2 treatment groups
Group A: Intra-Articular Cocktail InjectionExperimental treatment 5 interventions
Group B: No InjectionNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Pain as measured by Numerical Patient Reported Scale (NRPS)

Numerical Patient Reported Scale (NRPS), 0 (no pain) to 10 (worst pain imaginable)

Time frame
Pre-op, Post-op Day 1 to 3
2

Maximum Active Knee Flexion

The patient's Knee flexion is measured by a physiotherapist

Time frame
At post-op Day 1 to 3
3

Oral analgesics consumed

The level of the analgesic consumed (non-opioids, weak opioids, strong opioids), and the frequency of consumption

Time frame
Post-operative 2 weeks period
4

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.

Time frame
Post-op Day 14

Secondary outcomes

1

Length of hospital stay

The number of days the patient was hospitalised

Time frame
Through study completion, an average of 1 year
2

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.

Time frame
Through study completion, an average of 1 year
3

Incidence of Complications

Complications such as fracture site infection, loss of reduction, non-union, and malunion will be assessed and recorded

Time frame
Through study completion, an average of 1 year

Other outcomes

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