Intra-operative intra-articular analgesic cocktail for patella fracture fixation
Effects Of Intra-Operative Intra-Articular Cocktail Injection In Patella Open Reduction And Internal Fixation (ORIF): A Single Centre, Double Blinded, Randomised Control Trial
This trial will test whether giving an intra-articular analgesic cocktail during patella fixation surgery reduces pain and helps people get moving sooner after surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong, Hong Kong) |
| Trial ID | NCT07006168 on ClinicalTrials.gov |
What this trial studies
This single-center, double-blind, randomized controlled trial at Queen Mary Hospital compares patients who receive an intra-articular analgesic cocktail at the end of open reduction and internal fixation for patella fractures with those who do not. Participants are randomized 1:1 and both patients and outcome assessors are blinded to group allocation. Primary outcomes include postoperative pain relief and functional recovery; secondary outcomes include hospital length of stay and bed-stay related complications to estimate economic effects. The cocktail contains ketorolac, ropivacaine, triamcinolone, adrenaline and saline and is delivered intra-articularly after fixation.
Who should consider this trial
Good fit: Adults with an acute closed patella fracture who are scheduled for open reduction and internal fixation, can give consent, and were able to walk before the injury are ideal candidates.
Not a fit: Patients with open fractures, polytrauma, prior knee arthroplasty, chronic pain conditions, certain chronic illnesses (for example insulin-dependent diabetes, peptic ulcer disease, hepatitis B/C, or severe renal impairment), or those on strong opioids or immune-suppressing drugs were excluded and are unlikely to be eligible or benefit from this protocol.
Why it matters
Potential benefit: If successful, the injection could lower early postoperative pain, improve early knee motion and shorten hospital stays.
How similar studies have performed: Similar peri-articular analgesic cocktail injections have reduced early postoperative pain and improved early motion in arthroplasty patients, though their use specifically after patella fracture fixation has been less studied.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Hong Kong, Hong Kong
- Queen Mary Hospital, The University of Hong Kong — Hong Kong, Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Christian Fang — Dept of Orthopaedics and Traumatology, Queen Mary Hospital
- Study coordinator: Christian FANG
- Email: cfang@hku.hk
- Phone: +852 22554581
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.