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NCT Number: NCT07006168

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Queen Mary Hospital, The University of Hong Kong

Hong Kong

Location status: Recruiting

Location contact

Christian FANG

CONTACT

[email protected]

+852 22554581

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Pain as measured by Numerical Patient Reported Scale (NRPS)

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

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

  2. Maximum Active Knee Flexion

    Time frame: At post-op Day 1 to 3

    The patient's Knee flexion is measured by a physiotherapist

  3. Oral analgesics consumed

    Time frame: Post-operative 2 weeks period

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

  4. Tegner Lysholm Knee Score

    Time frame: Post-op Day 14

    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.

  5. Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: Post-op Day 14

    The KOOS's five patient-relevant dimensions are scored separately: Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items). A Likert scale is used, and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems), and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.

  6. 9-item Quality of Recovery Score (QoR-9 Score)

    Time frame: Post-op Day 1 to 3

    The QoR-9 has 9 questions evaluating the quality of recovery after surgery and anaesthesia. It is a patient-rated score ranging from 0 (worst) to 2 (best).

Secondary outcomes

  1. Length of hospital stay

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

    The number of days the patient was hospitalised

  2. Time to radiological bony union

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

    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.

  3. Incidence of Complications

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Christian FANG

CONTACT

[email protected]

+852 22554581

Christian Fang

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jun 5, 2025
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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