Repeat Dose Steroid to Prevent Pain Relapse After Total Knee Arthroplasty in Patients With High Pain Response

NCT05563155 | Completed Phase 4

• 1 other identifier: Repeat Dose
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to compare the effect of a repeat moderate dose of glucocorticoids postoperatively after preoperative high dose upon postoperative pain after Total Knee Arthroplasty (TKA) in an High Pain Respondes (HPR) population to a standard single high dose systemic preoperative administration in an HPR population. As a standard procedure, all patients referred to the outpatient clinic due to suspected degenerative knee disease will be asked to fulfill the Pain Catastrophizing Scale (PCS). If TKA is decided, patients with a PCS score above 20 will be treated with intravenously administered Dexamethasone 1 mg/kg as a rounded-up-dose to closest 10 mg according to our guideline for FAST-TRACK TKA. The repeat-dosing group (RDG) will receive a dose of 24 mg dexamethasone tablets at 9-11 pm on the first postoperative day. The control-group (CG) will receive placebo tablets at 9-11 pm on the first postoperative day.

Conditions

Post Operative Pain, Acute

Keywords

Dexamethason; repeat; glucocorticoids; TKA surgery; steroids; High Pain Responders; postoperative pain; repeat dosing; FAST-TRACK

Outcome Measures

Primary Outcomes (1)

• Postoperative pain after 48 hours / day 2 morning, according to VAS-scale

  The amount of patients with moderate postoperative pain in a 5 meter walk test day 2 morgning(48 hours) postoperatively after total knee-arthroplasty. Pain is monitored by the Visual Analog Scale(VAS) 0-100 mm, where 0 is no pain and 100 mm is the worst pain. Moderate pain is considered a VAS \>30 mm.

  Day 2 morning

Secondary Outcomes (8)

• Cumulated pain upon ambulation, according to VAS-scale (0-100mm), in a 5-meter walk test

  From day 2-3

• Cumulated pain score, according to VAS-scale (0-100mm), at rest, upon ambulation in a 5-meter walk test and at night according to VAS-scale(0-100mm)

  From day 2-7

• Quality of sleep, lethargy, dizziness, and nausea postoperative registration, according to the VAS-scale(0-100mm)

  From day 2-7

• Cumulative use of rescue analgesics per day.

  From day 2-7

• Patient satisfaction with analgesic regimen in a ordinal scale from 0 to 10

  Day 7

Study Arms (2)

Placebo tablet on day 1 after surgery given as one single dose.

PLACEBO COMPARATOR

Control Group (CG): Intervention: Postoperative oral placebo tablet on day 1 after surgery given as one single dose.

Drug: Placebo

Dexamethasone 24 mg on day 1 after surgery given as one single dose.

ACTIVE COMPARATOR

Repeat Dose Group (RDG): Intervention: Postoperative oral dexamethasone 24 mg on day 1 after surgery given as one single dose.

Drug: Dexamethasone 24 mg

Interventions

Dexamethasone 24 mg DRUG

Dexamethasone 24 mg on day 1 after surgery.

Also known as: Dexa-ratiopharm

Dexamethasone 24 mg on day 1 after surgery given as one single dose.

Placebo DRUG

Placebo tablet given on day 1 after surgery.

Placebo tablet on day 1 after surgery given as one single dose.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 40 years.
• Primary unilateral TKA.
• Ability to participate in the study (understand written and spoken Danish language, self-reported pain and satisfaction).
• Signed written informed consent form.
• PCS \>20.
• Moderate to severe postoperative pain (VAS \>30) in a 5-meter walk test 22-26 hours after end of surgery.

You may not qualify if:

• Ongoing treatment of systemic glucocorticoids or other immunosuppressant treatment apart from inhaled steroids.
• Insulin-dependent diabetes.
• Pregnancy or breastfeeding.\*
• Allergies concerning the study-drug.
• Mental disability that could impair a patient's decision-making capability of giving informed consent and not enabling valid data collection.
• Patients with known diagnoses of schizophrenia, ongoing psychosis, bipolar disease and/or a history of ongoing anti-psychotic treatment.
• Patients with modulated pain-reception (experience) based on other diseases or injuries, e.g. spinal cord or brain injury, severe polyneuropathies or neurologic disorders.
• Peripheral nerve block per- or postoperatively.

Sponsors & Collaborators

• Vejle Hospital: lead
• Hvidovre University Hospital: collaborator

Study Sites (1)

Vejle Hospital. Orthopedic Surgery Department. Clinical Research Unit

Vejle, 7100, Denmark

Location

Related Publications (27)

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MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding The patient, all personnel attending in treatment and care of the patient, the investigators and the sponsor will all be blinded to the study-drug allocation, until all data processing is finished. The randomization-sequence will be stored in a sealed envelope at the Pharmacy at Lillebaelt Hospital who carried out the packaging-process. The randomization personnel have no contact to the patient.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A double-blind randomization will be carried out, 5:5 block-randomization, half of which will be allocated to the CG and the other half to RDG. Group 1: Postoperative placebo tablet on day 1 after surgery. Group 2: Postoperative dexamethasone 24 mg tablet on day 1 after surgery.

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: October 3, 2022
• Study Start: November 1, 2021
• Primary Completion: March 22, 2024
• Study Completion: March 22, 2024
• Last Updated: June 28, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available from the date of publication

Locations

DK (1)