The Effect of Perioperative Dexamethasone Administration on Postoperative Pain in Patients Undergoing Periacetabular Osteotomy.

Postoperative Pain Clinical Trial

— PAODEX  

Official title:

The Effect of Perioperative Dexamethasone Administration on Postoperative Pain in Patients Undergoing Periacetabular Osteotomy: A Randomised Double-blind, Placebo-controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03874936
• Other study ID #: SO_SH_01_2019
• Secondary ID: 2019_000402_30
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: November 12, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2024
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Developmental Dysplasia of the Hip
• Dexamethasone
• Hip Dislocation
• Hip Dislocation, Congenital
• Hip Dysplasia
• Pain, Postoperative
• Postoperative Nausea and Vomiting
• Postoperative Pain
• Vomiting

Intervention

Drug:
• Dexamethasone 24mg Solution for Injection
Administrated i.v.
• Saline Solution for Injection
administrated i.v.

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense

Sponsors (2)

Lead Sponsor	Collaborator
Odense University Hospital	Odense Patient Data Explorative Network

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cumulated postoperative morphine consumption in milligrams after 24hours.	Morphine administered both as patient-controlled analgesia (PCA) i.v. morphine and any other supplemental morphine administered postoperatively. Consumption in mg.	0-24 hours postoperatively
Other	Cumulated antiemetic consumption	antiemetic consumption in mg and drug will be assessed after 24hrs.	0-24 hours postoperatively
Other	Fasting blood glucose	assessment of fasting blood glucose in mg/mL	0 hours, 6 hours, 24 hours, 48 hours (72 hours)
Other	C-reactive protein (CRP)	blood sample to evaluate the influence of dexamethasone on the postoperative inflammation development.	0, 6, 24, 48 hours (72 hours) postoperatively
Other	Leucocytes	blood sample to evaluate the influence of dexamethasone on the postoperative inflammation development.	0, 6, 24, 48 hours (72 hours) postoperatively
Other	Cytokines	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	0, 6, 24, 48 hours (72 hours) postoperatively
Other	Patient reported outcome measure, quality of life	Based on the questionnaire: EuroQol - 5 Dimensions (EQ-5D) after 3 and 6 months and 1 year follow up.	3, 6, 12 months postoperatively
Other	Patient reported outcome measures, health	Patient evaluated health based on the questionnaire: University of California, Los Angeles (UCLA) after 3 and 6 months and 1 year follow up.	3, 6, 12 months postoperatively
Other	Patient reported outcome measures, the Oxford Hip questionnaire	Patient evaluated activity and pain, based on the questionnaire: Oxford Hip after 3 and 6 months and 1 year follow up.	3, 6, 12 months postoperatively
Primary	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.	0-48 hours postoperatively
Secondary	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).	24, 48 hours postoperatively
Secondary	Cumulated postoperative morphine consumption from 48 hours until day 14 post operation	Morphine consumption in milligrams after the operation.	48 hours - day 14 postoperatively
Secondary	Postoperative nausea and vomiting	Nausea and vomiting are evaluated using a 4 point scale: none, mild, moderate, severe	24 and 48 hours postoperatively
Secondary	Antiemetic consumption	Evaluation of cumulated antiemetic consumption in mg and drug will be assessed.	0-48 hours postoperatively
Secondary	Sleep	Sleep quality will be assessed using the VAS scale (0-100)	0-7 days postoperatively
Secondary	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.	24, 48 hours postoperatively
Secondary	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.	0-8 weeks after operation