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

Femoral Neck Fractures Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05023369
• Other study ID #: ORL - ORT - 028
• Status: Recruiting
• Phase: Phase 4
• Start date: December 10, 2021
• Est. completion date: November 1, 2024

Study information

• Verified date: December 2023
• Source: Ente Ospedaliero Cantonale, Bellinzona
• Contact: Christian MD Candrian, Prof.
• Phone: 0041918117029
• Email: Gabriela.Induni-Lang[@]eoc.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Femoral Neck Fractures

Intervention

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

Locations

Country	Name	City	State
Switzerland	Christian Candrian	Lugano

Sponsors (1)

Lead Sponsor	Collaborator
Ente Ospedaliero Cantonale, Bellinzona

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain	The mean post-operative daily pain in the first three days after surgery assessed with the 0-10 numeric rating scale (NRS)	3 days after surgery
Secondary	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	Up to 24 months
Secondary	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.	Up to 24 months
Secondary	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	Up to 24 months
Secondary	PainDETECT	PainDETECT questionnaire for identifying neuropathic pain component and patient satisfaction on a two-level scale at 6, 12, 24 months	Up to 24 months
Secondary	Nausea	Post-operative nausea documented during the 3 first post-operative days (both incidence and intensity on a 0-10 NRS)	3 days after surgery
Secondary	Opioids and analgesic	Post-operative opioids and analgesic drugs consumption documented with Medication Quantification Scale score (MQS) daily during the first 6 weeks and then at 3, 6, 12, 24 months postoperatively	Up to 24 months
Secondary	PCR & ESR	Post-operative inflammatory response in terms of hematic C-Reactive Protein (CRP) and erythrocyte sedimentation rate (ESR) documented every day in the first 3 post-operative days	3 days after surgery
Secondary	Mobilization	Time from surgery to first mobilization	Up to week 2
Secondary	Length of hospital stay	The length of hospital stay	Up to week 2
Secondary	Patient Satisfaction	the satisfaction of the patient with the surgical procedure	reported on a 0-10 NRS at 2 and 6 weeks, 3, 6, 12, 24 months
Secondary	Hip ROM	range of movement of the operated hip	evaluation of range of motion preoperatively, at discharge and at 2 and 6 weeks, and at 3, 6, 12, 24 months postoperatively.