Clinical trial NCT05023369: This is a Study to Verify if Periarticular Hip Injection of Corticosteroid After Hip Replacement Reduce the Pain and the Hospitalisation Time
Official title: Periarticular Administration of Dexamethasone to Improve Post-operative Pain, Function, Nausea, Hospitalization Length, and Risk of Complications in Patients Undergoing Hip Arthroplasty - A Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Femoral Neck Fractures
Lead sponsor: Ente Ospedaliero Cantonale, Bellinzona
Sponsor class: OTHER
First posted: 2021-08-26
Enrollment: 110
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Hip endoprothesis is a common orthopaedic prosthetic procedure, with continuously growing numbers in the last years, and the demand for this procedure is predicted to increase 4-fold by 2030. Recently, major interest has been given to improve postoperative pain management, to decrease the discomfort of the patients and with an outlook for reducing the length of hospital stay and decrease health-care costs. However, postoperative pain management is still problematic after this operation.

Post-operative pain control with the optimization of the analgesia protocol is a key aspect to be addressed to reduce the need for opioid analgesics, to quicken recovery and mobilisation, and to decrease the hospitalization length. To this regard, steroid supplementation is considered effective in decreasing post-operative pain. A recent meta-analysis from our research group on patients with total knee prosthesis proved the efficacy in decreasing post-operative pain. Moreover, a positive effect has been documented in terms of lower incidence of nausea and vomit, less post-operative range of motion limitation, and decreased systemic inflammatory response. All these benefits produced a shortened length of hospital stay without an increased risk of complications such as local infections.

Despite this overall positive effect of steroid supplementation, and their use by other specialties - e.g. anaesthesiology - and while there is now good evidence about the benefits of periarticular hip analgesic injection, e.g. FANS, opioid etc., there is still lacking evidence on the efficacy of periarticular corticosteroids in patients undergoing hip prosthetic replacement. In fact, there is a lack of information in the literature on their effectiveness in terms of pain management and function recovery. Furthermore, the influence of perioperative steroid application on the long-term follow-up results is poorly explored. This is a key issue, since the intensity of acute post-operative pain has been widely related to the risk of developing chronic post-operative pain, and thus the advantages of steroid supplementation, could go beyond the short-term pain relief and be even longer lasting.

This randomized controlled trial will thus investigate the benefit of implementing the peri-operative analgesia protocol not only to improve the acute post-operative recovery and shorten the hospital stay, but also to optimize the overall results after hip endoprosthesis.

Eligibility criteria: Inclusion Criteria:

* 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
* Informed Consent as documented by signature

Exclusion Criteria:

* Contraindications to steroids
* Revision endoprosthesis
* Active steroid or immunosuppressive therapy in the last 30 days before the operation
* Pregnant or breast-feeding women
* Presence of other clinically significant concomitant disease states (ASA IV)
* Uncontrolled diabetes mellitus
* Contraindications to NSAIDs
* Chronic systemic diseases as immunodeficiency, autoimmune disease (Systemic Lupus Erythematosus, SLE), gout, rheumatic arthritis
* Known or suspected non-compliance, drug or alcohol abuse
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
* Participation in another study with investigational drug within the 30 days preceding and during the present study
* Previous enrolment into the current study
* Enrolment of the investigator, his/her family members, employees and other dependent persons.

Primary outcomes:
measure: Postoperative pain
timeFrame: 3 days after surgery
Secondary outcomes:
measure: Hip pain and function on a numeric rating scale (NRS)
timeFrame: Up to 24 months
measure: Hip pain, function and quality of life on Harris Hip Score
timeFrame: Up to 24 months
measure: Hip pain, function and quality of life on EQ-5D-5L Score
timeFrame: Up to 24 months
measure: PainDETECT
timeFrame: Up to 24 months
measure: Nausea
timeFrame: 3 days after surgery
measure: Opioids and analgesic
timeFrame: Up to 24 months
measure: PCR & ESR
timeFrame: 3 days after surgery
measure: Mobilization
timeFrame: Up to week 2
measure: Length of hospital stay
timeFrame: Up to week 2
measure: Patient Satisfaction
timeFrame: reported on a 0-10 NRS at 2 and 6 weeks, 3, 6, 12, 24 months
measure: Hip ROM
timeFrame: evaluation of range of motion preoperatively, at discharge and at 2 and 6 weeks, and at 3, 6, 12, 24 months postoperatively.
Other outcomes:
Locations:
city: Lugano
country: Switzerland
facility: Christian Candrian
Study officials:
affiliation: EOC
name: Christian MD Candrian, Prof.
role: PRINCIPAL_INVESTIGATOR
References: