Dexamethasone Twice for Pain Treatment of Total Knee Arthroplasty

NCT03506789 | Completed Phase 4 DMC

• 1 other identifier: SM1-KAKG-2018
• Study Type: interventional
• Target: 485
• Locations: 1 country
• Sites: 5

Brief Summary

Dexamethasone twice for pain treatment after total knee arthroplasty - A Placebo-controlled, randomised, parallel 3-group multicentre trial of one and two doses of dexamethasone for postoperative treatment

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Cumulative usage of morphine 0-48 hours postoperatively

  Morphine administered both as patient-controlled analgesia (PCA) i.v. morphine 0-24 hours and oral morphine on demand 24-48 hours, and any other supplemental morphine administered postoperatively. Consumption in mg

  0-48 hours postoperatively

Secondary Outcomes (2)

• VAS-pain scores (visual analogue scale (VAS))

  24 and 48 hours postoperatively

• Adverse events, patient-reported

  0-48 hours postoperatively

Other Outcomes (19)

• Number of patients with one or more serious adverse events (SAE)

  90 days postoperatively

• 90 days follow-up

  90 days postoperatively

• Total need of i.v. morphine 0-24 hours postoperatively

  0-24 hours postoperatively

Study Arms (3)

Treatment A:

ACTIVE COMPARATOR

24 mg dexamethasone i.v. perioperatively and 24 mg dexamethasone i.v. on the first postoperative day

Drug: Dexamethasone

Treatment B:

ACTIVE COMPARATOR

24 mg dexamethasone i.v. perioperatively and placebo (isotonic saline) i.v. on the first postoperative day

Drug: Dexamethasone; Drug: Placebos

Placebo

PLACEBO COMPARATOR

Placebo (isotonic saline) i.v. perioperatively and placebo (isotonic saline) i.v. on the first postoperative day

Drug: Placebos

Interventions

Dexamethasone DRUG

Dexamethasone 24 mg

Treatment A:; Treatment B:

Placebos DRUG

Isotonic saline

Placebo; Treatment B:

Eligibility Criteria

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

You may qualify if:

• Scheduled for unilateral, primary total knee arthroplasty
• ASA 1-3
• BMI ≥ 18.0 and ≤ 40.0
• Negative urine HCG pregnancy test and use of anti-conception for women in the fertile age
• Patients who gave their written informed consent to participating in the trial after having fully understood the contents of the protocol and restrictions

You may not qualify if:

• Patients who cannot cooperate with the trial
• Concomitant participation in another trial involving medication
• Patients who cannot understand or speak Danish
• Patients with allergy to medication used in the trial
• Patients with daily use of high dose opioid (\> oral morphine 30 mg/day or oxycodone 30 mg/day or tramadol 150 mg/day) or any use of other opioids including methadone and transdermal opioids.
• Patients with at daily use of systemic glucocorticoids
• Contraindications against ibuprofen or paracetamol, for example previous ulcer, known heart failure, known liver failure, or known renal failure (eGRF \< 60 ml/kg/1,73m2), known thrombocytopenia (\<100 bil/l); or against treatment with glucocorticoids.
• Dysregulated diabetes (investigators judgement)
• Patients suffering from alcohol and/or drug abuse - based on the investigator's judgement

Sponsors & Collaborators

• Naestved Hospital: lead

Study Sites (5)

Gildhøj Privathospital

Brøndby, 2605, Denmark

Location

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

Sjællands Universitetshospital, Køge

Køge, 4600, Denmark

Location

Næstsved Sygehus

Næstved, 4700, Denmark

Location

Odense Universitetshospital

Odense, 5000, Denmark

Location

Related Publications (5)

• Molgaard AK, Gasbjerg KS, Mathiesen O, Hagi-Pedersen D, Gogenur I. Dexamethasone vs. placebo modulation of the perioperative blood immune proteome in patients undergoing total knee arthroplasty. BMC Anesthesiol. 2025 Mar 21;25(1):136. doi: 10.1186/s12871-025-03003-3.

  PMID: 40119286 DERIVED

• Derby CB, Gasbjerg KS, Hagi-Pedersen D, Lunn TH, Pedersen NA, Lindholm P, Brorson S, Schroder HM, Thybo KH, Bagger J, Lindberg-Larsen M, Overgaard S, Jakobsen JC, Mathiesen O. Prolonged effects of dexamethasone following total knee arthroplasty: A pre-planned sub-study of the DEX-2-TKA trial. Acta Anaesthesiol Scand. 2024 Jan;68(1):35-42. doi: 10.1111/aas.14319. Epub 2023 Sep 14.

  PMID: 37709280 DERIVED

• Gasbjerg KS, Hagi-Pedersen D, Lunn TH, Laursen CC, Holmqvist M, Vinstrup LO, Ammitzboell M, Jakobsen K, Jensen MS, Pallesen MJ, Bagger J, Lindholm P, Pedersen NA, Schroder HM, Lindberg-Larsen M, Norskov AK, Thybo KH, Brorson S, Overgaard S, Jakobsen JC, Mathiesen O. Effect of dexamethasone as an analgesic adjuvant to multimodal pain treatment after total knee arthroplasty: randomised clinical trial. BMJ. 2022 Jan 4;376:e067325. doi: 10.1136/bmj-2021-067325.

  PMID: 34983775 DERIVED

• Gasbjerg KS, Hagi-Pedersen D, Lunn TH, Overgaard S, Pedersen NA, Bagger J, Lindholm P, Brorson S, Schroder HM, Thybo KH, Mathiesen O, Jakobsen JC. DEX-2-TKA - DEXamethasone twice for pain treatment after Total Knee Arthroplasty: Detailed statistical analysis plan for a randomized, blinded, three-group multicentre clinical trial. Acta Anaesthesiol Scand. 2020 Jul;64(6):839-846. doi: 10.1111/aas.13560. Epub 2020 Mar 3.

  PMID: 32048274 DERIVED

• Gasbjerg KS, Hagi-Pedersen D, Lunn TH, Jakobsen JC, Overgaard S, Pedersen NA, Bagger J, Lindholm P, Brorson S, Schroder HM, Thybo KH, Mathiesen O. DEX-2-TKA-DEXamethasone twice for pain treatment after Total Knee Arthroplasty: A protocol for a randomized, blinded, three-group multicentre clinical trial. Acta Anaesthesiol Scand. 2020 Feb;64(2):267-275. doi: 10.1111/aas.13481. Epub 2019 Oct 18.

  PMID: 31544230 DERIVED

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 Officials

• Ole Mathiesen, MD, PhD, Assoc Prof

  Department of Anaesthesiology, Zealand University Hospital, Køge

  STUDY CHAIR

• Daniel Hägi-Pedersen, MD, PhD

  Department of Anaesthesiology, Næstved Hospital

  STUDY CHAIR

• Jørgen B Dahl, DMSc

  Department of Anaesthesiology, Bispebjerg Hospital

  STUDY CHAIR

• Kasper S Gasbjerg, MD

  Department of Anaesthesiology, Næstved Hospital

  PRINCIPAL INVESTIGATOR

• Troels H Lunn, DMSc

  Department of Anaesthesiology, Bispebjerg Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2018
• First Posted: April 24, 2018
• Study Start: September 14, 2018
• Primary Completion: March 11, 2020
• Study Completion: June 7, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

DK (5)