This is a Study to Verify if Periarticular Hip Injection of Corticosteroid After Hip Replacement Reduce the Pain and the Hospitalisation Time
Primary Purpose
Femoral Neck Fractures
Status
Recruiting
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Dexamethasone is a steroid drug and will be administered as an injectable solution (4mg/ml)
Sponsored by
About this trial
This is an interventional treatment trial for Femoral Neck Fractures
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.
Sites / Locations
- Christian CandrianRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Dexamethasone group
Routine care
Arm Description
Patient in this group will receive administration of 9 mg dexamethasone injected in the peri-articular tissues after the bone cut for hip endoprosthesis
In this group only routinely performed anaesthesia protocol will be provided
Outcomes
Primary Outcome Measures
Postoperative pain
The mean post-operative daily pain in the first three days after surgery assessed with the 0-10 numeric rating scale (NRS)
Secondary Outcome Measures
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
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.
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
PainDETECT
PainDETECT questionnaire for identifying neuropathic pain component and patient satisfaction on a two-level scale at 6, 12, 24 months
Nausea
Post-operative nausea documented during the 3 first post-operative days (both incidence and intensity on a 0-10 NRS)
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
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
Mobilization
Time from surgery to first mobilization
Length of hospital stay
The length of hospital stay
Patient Satisfaction
the satisfaction of the patient with the surgical procedure
Hip ROM
range of movement of the operated hip
Full Information
NCT ID
NCT05023369
First Posted
August 12, 2021
Last Updated
March 29, 2023
Sponsor
Ente Ospedaliero Cantonale, Bellinzona
1. Study Identification
Unique Protocol Identification Number
NCT05023369
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 10, 2021 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ente Ospedaliero Cantonale, Bellinzona
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Neck Fractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dexamethasone group
Arm Type
Experimental
Arm Description
Patient in this group will receive administration of 9 mg dexamethasone injected in the peri-articular tissues after the bone cut for hip endoprosthesis
Arm Title
Routine care
Arm Type
No Intervention
Arm Description
In this group only routinely performed anaesthesia protocol will be provided
Intervention Type
Drug
Intervention Name(s)
Dexamethasone is a steroid drug and will be administered as an injectable solution (4mg/ml)
Other Intervention Name(s)
Mephameson
Intervention Description
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)
Primary Outcome Measure Information:
Title
Postoperative pain
Description
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 Outcome Measure Information:
Title
Hip pain and function on a numeric rating scale (NRS)
Description
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
Title
Hip pain, function and quality of life on Harris Hip Score
Description
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
Title
Hip pain, function and quality of life on EQ-5D-5L Score
Description
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
Title
PainDETECT
Description
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
Title
Nausea
Description
Post-operative nausea documented during the 3 first post-operative days (both incidence and intensity on a 0-10 NRS)
Time Frame
3 days after surgery
Title
Opioids and analgesic
Description
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
Time Frame
Up to 24 months
Title
PCR & ESR
Description
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
Time Frame
3 days after surgery
Title
Mobilization
Description
Time from surgery to first mobilization
Time Frame
Up to week 2
Title
Length of hospital stay
Description
The length of hospital stay
Time Frame
Up to week 2
Title
Patient Satisfaction
Description
the satisfaction of the patient with the surgical procedure
Time Frame
reported on a 0-10 NRS at 2 and 6 weeks, 3, 6, 12, 24 months
Title
Hip ROM
Description
range of movement of the operated hip
Time Frame
evaluation of range of motion preoperatively, at discharge and at 2 and 6 weeks, and at 3, 6, 12, 24 months postoperatively.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christian MD Candrian, Prof.
Phone
0041918117029
Email
Gabriela.Induni-Lang@eoc.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Gabriela Induni-Lang
Phone
0041918117029
Email
Gabriela.Induni-Lang@eoc.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian MD Candrian, Prof.
Organizational Affiliation
EOC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Christian Candrian
City
Lugano
ZIP/Postal Code
6900
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Candrian, Prof.Dr.med
Phone
+41 (0) 91 811 61 23
Email
christian.candrian@eoc.ch
First Name & Middle Initial & Last Name & Degree
Gianluigi Capone, Dr.
Email
gianluigi.capone@eoc.ch
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
This is a Study to Verify if Periarticular Hip Injection of Corticosteroid After Hip Replacement Reduce the Pain and the Hospitalisation Time
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