This is a Study to Verify if Periarticular Hip Injection of Corticosteroid After Hip Replacement Reduce the Pain and the Hospitalisation Time

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age50-90
SponsorEnte Ospedaliero Cantonale, Bellinzona

About this trial

The investigators are going to evaluate if periarticular corticosteroid injection during endoprothesis implantation can lead to any advantage to the patients, namely if it can reduce post-operative pain, lenght and cost of hospitalisation, use of analgesics drugs.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients undergoing unilateral cemented hip endoprosthesis for femoral neck fracture

Patients aged 50-90 years old

Patients with a BMI >18.5 and <35

Patients able to provide informed consent and follow all the study procedures as indicated by the protocol

Disqualifiers

Contraindications to steroids

Revision endoprosthesis

Active steroid or immunosuppressive therapy in the last 30 days before the operation

Pregnant or breast-feeding women

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexamethasone is a steroid drug and will be administered as an injectable solution (4mg/ml)

    Drug

    Dexamethasone will be administered as an injectable solution (4mg/ml). Every ml of this solution contains 4 mg of dexamethasone sodium phosphate, corresponding to 3 mg of dexamethasone. Thus 3 ml of solution will be injected peri-articularly (arm-A)

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Dexamethasone groupExperimental treatment 1 intervention
Group B: Routine careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Postoperative pain

The mean post-operative daily pain in the first three days after surgery assessed with the 0-10 numeric rating scale (NRS)

Time frame
3 days after surgery

Secondary outcomes

1

Hip pain and function on a numeric rating scale (NRS)

Hip pain and general function documented on a 0-10 NRS preoperatively and during the first 3 months, and reported on a 0-10 NRS at 2 and 6 weeks, 3, 6, 12, 24 months

Time frame
Up to 24 months
2

Hip pain, function and quality of life on Harris Hip Score

hip pain, function and quality of life evaluated by the validated clinical Harris Hip Score preoperatively and at 2 and 6 weeks, and at 3, 6, 12, 24 months postoperatively. The Harris Hip Score is a measure of dysfunction; the maximum score possible is 100 and the higher the score, the better the outcome for the individual.

Time frame
Up to 24 months
3

Hip pain, function and quality of life on EQ-5D-5L Score

hip pain, function and quality of life evaluated by the validated patient reported outcome measures EQ-5D-5L Scores preoperatively and at 2 and 6 weeks, and at 3, 6, 12, 24 months postoperatively

Time frame
Up to 24 months
4

PainDETECT

PainDETECT questionnaire for identifying neuropathic pain component and patient satisfaction on a two-level scale at 6, 12, 24 months

Time frame
Up to 24 months

Other outcomes

Sponsors and contacts

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