The Effect of Perioperative Dexamethasone Administration on Postoperative Pain in Patients Undergoing Periacetabular Osteotomy. (PAODEX)
Primary Purpose
Dexamethasone, Hip Dysplasia, Postoperative Pain
Status
Recruiting
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Dexamethasone 24mg Solution for Injection
Saline Solution for Injection
Sponsored by
About this trial
This is an interventional prevention trial for Dexamethasone focused on measuring postoperative pain, dexamethasone, pain management
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing PAO due to symptomatic hip dysplasia (CE<25grader) or retroverted acetabulum (crossover and posterior wall sign)
- ≥ 18 years
- Females if fertile: Verified negative human chorionic gonadotropin (HCG), usage of safe contraceptives or surgical sterilisation.
- Patients who give their written informed consent to participating in the trial, after having fully understood the content of the protocol and restrictions.
Exclusion Criteria:
- Patients who cannot speak or understand Danish
- Allergy or contraindications to trial medication
- Spinal anaesthesia
- Second intervention carried out simultaneously (e.g. femur osteotomy)
- Patients with daily opioid consumption prior to surgery (tramadol and codeine accepted)
- Drug, medical abuse or weekly alcohol consumption beyond ≥7 (female) and ≥14 (men) units, respectively.
- Mental disability, anxiety disorder (active psychiatric disorder or consumption of tricyclic antidepressants)
- Diabetes diagnosed prior to inclusion
- Immune suppression therapy (e.g. systemic glucocorticoids)
- Kidney impairment (eGFR < 50ml/min) or liver disease (≥Child Pugh B)
Sites / Locations
- Odense University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
A; Dexamethasone twice
B; Dexamethasone once
C; Placebo twice
Arm Description
24mg intravenous Dexamethasone (Dexavital®, Vital Pharma) 4mg/ml just before the operation and repeated after 24 hours.
24mg intravenous Dexamethasone just before the operation and placebo which is 6ml of isotonic sodium chloride (9mg/ml, 'normal' saline) after 24 hours
placebo intravenous just before the operation and repeated after 24 hours
Outcomes
Primary Outcome Measures
Cumulated postoperative morphine consumption in milligrams after 48 hours.
Morphine administered both as patient-controlled analgesia (PCA) i.v. morphine and any other supplemental morphine administered postoperatively. Consumption in mg.
Secondary Outcome Measures
Postoperative pain intensity after 48 hours.
Pain is evaluated at rest and under the timed-up-and-go (TUG) procedure. Pain intensity is assessed using the visual analogue scale (VAS) (0-100mm).
Cumulated postoperative morphine consumption from 48 hours until day 14 post operation
Morphine consumption in milligrams after the operation.
Postoperative nausea and vomiting
Nausea and vomiting are evaluated using a 4 point scale: none, mild, moderate, severe
Antiemetic consumption
Evaluation of cumulated antiemetic consumption in mg and drug will be assessed.
Sleep
Sleep quality will be assessed using the VAS scale (0-100)
Timed up and go test
Is assessed from; the time that the participant takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
Serious adverse events (SAE)
SAE's including wound infection treated with antibiotics or revision. Patients will be asked for SAE during the intervention period, at a follow-up visit 8 weeks the operation. This will be supplemented with a look up for prescriptions.
Full Information
NCT ID
NCT03874936
First Posted
March 6, 2019
Last Updated
May 6, 2022
Sponsor
Odense University Hospital
Collaborators
Odense Patient Data Explorative Network
1. Study Identification
Unique Protocol Identification Number
NCT03874936
Brief Title
The Effect of Perioperative Dexamethasone Administration on Postoperative Pain in Patients Undergoing Periacetabular Osteotomy.
Acronym
PAODEX
Official Title
The Effect of Perioperative Dexamethasone Administration on Postoperative Pain in Patients Undergoing Periacetabular Osteotomy: A Randomised Double-blind, Placebo-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 12, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital
Collaborators
Odense Patient Data Explorative Network
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is an investigator-initiated, Danish mono-center, randomized, placebo-controlled, parallel group, double-blind, superiority trial of dexamethasone on postoperative pain management on patients undergoing operation for hip dysplasia with the periacetabular osteotomy procedure (PAO). 90 adults undergoing PAO will be enrolled.
The primary outcome is to compare the effect of dexamethasone relative to placebo on cumulated postoperative morphine consumption at 48 hours.
Key secondary outcomes include comparing the effect of repeated doses of dexamethasone relative to a single dose on cumulated postoperative morphine consumption at 48 hours, and to determine if dexamethasone is superior to placebo for: Perception of pain intensity, prevalence and degree of postoperative nausea and vomiting, and patient-reported outcome measures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dexamethasone, Hip Dysplasia, Postoperative Pain, Postoperative Nausea and Vomiting
Keywords
postoperative pain, dexamethasone, pain management
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A; Dexamethasone twice
Arm Type
Experimental
Arm Description
24mg intravenous Dexamethasone (Dexavital®, Vital Pharma) 4mg/ml just before the operation and repeated after 24 hours.
Arm Title
B; Dexamethasone once
Arm Type
Experimental
Arm Description
24mg intravenous Dexamethasone just before the operation and placebo which is 6ml of isotonic sodium chloride (9mg/ml, 'normal' saline) after 24 hours
Arm Title
C; Placebo twice
Arm Type
Placebo Comparator
Arm Description
placebo intravenous just before the operation and repeated after 24 hours
Intervention Type
Drug
Intervention Name(s)
Dexamethasone 24mg Solution for Injection
Other Intervention Name(s)
Dexa
Intervention Description
Administrated i.v.
Intervention Type
Drug
Intervention Name(s)
Saline Solution for Injection
Other Intervention Name(s)
Saline
Intervention Description
administrated i.v.
Primary Outcome Measure Information:
Title
Cumulated postoperative morphine consumption in milligrams after 48 hours.
Description
Morphine administered both as patient-controlled analgesia (PCA) i.v. morphine and any other supplemental morphine administered postoperatively. Consumption in mg.
Time Frame
0-48 hours postoperatively
Secondary Outcome Measure Information:
Title
Postoperative pain intensity after 48 hours.
Description
Pain is evaluated at rest and under the timed-up-and-go (TUG) procedure. Pain intensity is assessed using the visual analogue scale (VAS) (0-100mm).
Time Frame
24, 48 hours postoperatively
Title
Cumulated postoperative morphine consumption from 48 hours until day 14 post operation
Description
Morphine consumption in milligrams after the operation.
Time Frame
48 hours - day 14 postoperatively
Title
Postoperative nausea and vomiting
Description
Nausea and vomiting are evaluated using a 4 point scale: none, mild, moderate, severe
Time Frame
24 and 48 hours postoperatively
Title
Antiemetic consumption
Description
Evaluation of cumulated antiemetic consumption in mg and drug will be assessed.
Time Frame
0-48 hours postoperatively
Title
Sleep
Description
Sleep quality will be assessed using the VAS scale (0-100)
Time Frame
0-7 days postoperatively
Title
Timed up and go test
Description
Is assessed from; the time that the participant takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
Time Frame
24, 48 hours postoperatively
Title
Serious adverse events (SAE)
Description
SAE's including wound infection treated with antibiotics or revision. Patients will be asked for SAE during the intervention period, at a follow-up visit 8 weeks the operation. This will be supplemented with a look up for prescriptions.
Time Frame
0-8 weeks after operation
Other Pre-specified Outcome Measures:
Title
Cumulated postoperative morphine consumption in milligrams after 24hours.
Description
Morphine administered both as patient-controlled analgesia (PCA) i.v. morphine and any other supplemental morphine administered postoperatively. Consumption in mg.
Time Frame
0-24 hours postoperatively
Title
Cumulated antiemetic consumption
Description
antiemetic consumption in mg and drug will be assessed after 24hrs.
Time Frame
0-24 hours postoperatively
Title
Fasting blood glucose
Description
assessment of fasting blood glucose in mg/mL
Time Frame
0 hours, 6 hours, 24 hours, 48 hours (72 hours)
Title
C-reactive protein (CRP)
Description
blood sample to evaluate the influence of dexamethasone on the postoperative inflammation development.
Time Frame
0, 6, 24, 48 hours (72 hours) postoperatively
Title
Leucocytes
Description
blood sample to evaluate the influence of dexamethasone on the postoperative inflammation development.
Time Frame
0, 6, 24, 48 hours (72 hours) postoperatively
Title
Cytokines
Description
evaluate the decrease of cytokines concentration (Interleukin (IL)-2, IL-6, IL-10, tumor necrosis factor (TNF) and pentraxin 3 (PTX3) as markers of response during treatment with Dexamethasone
Time Frame
0, 6, 24, 48 hours (72 hours) postoperatively
Title
Patient reported outcome measure, quality of life
Description
Based on the questionnaire: EuroQol - 5 Dimensions (EQ-5D) after 3 and 6 months and 1 year follow up.
Time Frame
3, 6, 12 months postoperatively
Title
Patient reported outcome measures, health
Description
Patient evaluated health based on the questionnaire: University of California, Los Angeles (UCLA) after 3 and 6 months and 1 year follow up.
Time Frame
3, 6, 12 months postoperatively
Title
Patient reported outcome measures, the Oxford Hip questionnaire
Description
Patient evaluated activity and pain, based on the questionnaire: Oxford Hip after 3 and 6 months and 1 year follow up.
Time Frame
3, 6, 12 months postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing PAO due to symptomatic hip dysplasia (CE<25grader) or retroverted acetabulum (crossover and posterior wall sign)
≥ 18 years
Females if fertile: Verified negative human chorionic gonadotropin (HCG), usage of safe contraceptives or surgical sterilisation.
Patients who give their written informed consent to participating in the trial, after having fully understood the content of the protocol and restrictions.
Exclusion Criteria:
Patients who cannot speak or understand Danish
Allergy or contraindications to trial medication
Spinal anaesthesia
Second intervention carried out simultaneously (e.g. femur osteotomy)
Patients with daily opioid consumption prior to surgery (tramadol and codeine accepted)
Drug, medical abuse or weekly alcohol consumption beyond ≥7 (female) and ≥14 (men) units, respectively.
Mental disability, anxiety disorder (active psychiatric disorder or consumption of tricyclic antidepressants)
Diabetes diagnosed prior to inclusion
Immune suppression therapy (e.g. systemic glucocorticoids)
Kidney impairment (eGFR < 50ml/min) or liver disease (≥Child Pugh B)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Viktoria Lindberg-Larsen, MD, PhD
Phone
28791991
Ext
+45
Email
viktoria.lindberg-larsen@rsyd.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Stine Hebsgaard, MD
Phone
26814697
Ext
+45
Email
stine.hebsgaard3@rsyd.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Viktoria Lindberg-Larsen, MD, PhD
Organizational Affiliation
Dept. of Anesthesiology and Intensive Care Medicine, Odense University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Viktoria Lindberg-Larsen, MD, PhD
Phone
28791991
Ext
+45
Email
viktoria.lindberg-larsen@rsyd.dk
First Name & Middle Initial & Last Name & Degree
Viktoria Lindberg-Larsen, MD, PhD
First Name & Middle Initial & Last Name & Degree
Stine Hebsgaard, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Perioperative Dexamethasone Administration on Postoperative Pain in Patients Undergoing Periacetabular Osteotomy.
We'll reach out to this number within 24 hrs