DEX-2-TKA - DEXamethasone twice for pain treatment after Total Knee Arthroplasty. A protocol for a randomized, blinded, three-group multicentre clinical trial

Kasper Smidt Gasbjerg, Daniel Hägi-Pedersen, Troels Haxholdt Lunn, Janus Christian Jakobsen, Søren Overgaard, Niels Anker Pedersen, Jens Bagger, Peter Lindholm, Stig Brorson, Henrik Morville Schrøder, Kasper Højgaard Thybo, Ole Mathiesen

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Resumé

BACKGROUND: Multimodal analgesia is considered the leading principle for post-operative pain treatment, but no gold standard after total knee arthroplasty (TKA) exists.

AIM: To investigate the beneficial and harmful effects of one or two doses of 24 mg intravenous dexamethasone (DXM) as part of a multimodal analgesic regimen (paracetamol, NSAID and perioperative local infiltration analgesia) after TKA. We hypothesize that addition of DXM will reduce post-operative opioid consumption.

METHODS: DEXamethasone twice for pain treatment after TKA is a randomized, blinded, three-group multicentre clinical trial. Participants will be randomized to one of three groups: placebo, single dose of DXM or two consecutive doses of DXM. Participants, treatment providers and investigators will be blinded to the allocated intervention. The primary outcome is total opioid consumption (units of morphine equivalents) 0-48 hours post-operatively.

INCLUSION CRITERIA: unilateral, primary TKA; age ≥18 years; American Society of Anesthesiologists-Score 1-3; Body Mass Index ≥18 and ≤40; for women-not pregnant; and written informed consent.

EXCLUSION CRITERIA: allergy or contraindications against trial medication; daily use of high dose opioid and/or use of methadone/transdermal opioids; daily use of systemic glucocorticoids; dysregulated diabetes; and patients suffering from alcohol and/or drug abuse. Four-hundred-and-eighty-six eligible participants are needed to detect or discard a difference of 10 mg morphine equivalents 0-48 hours post-operatively maintaining a familywise error rate of 0.05 and a power of 90% for the three possible pairwise comparisons.

DISCUSSION: Recruiting is planned to commence September 2018 and expected to finish March 2020.

TRIAL REGISTRATION: EudraCT: 2018-001099-39 (08/06-18); ClinicalTrials.gov: NCT03506789 (24/04-2019). Editorial Comment This is the protocol for the largest randomized clinical trial investigating the effect of one or two doses of dexamethasones on pain treatment after total knee arthroplasty. Due to the pragmatic and rigerous design this study will deliver results of high quality and external validity.

OriginalsprogEngelsk
TidsskriftActa Anaesthesiologica Scandinavica
ISSN0001-5172
DOI
StatusE-pub ahead of print - 22. sep. 2019

Fingeraftryk

Knee Replacement Arthroplasties
Multicenter Studies
Clinical Trials
Morphine
Methadone
Acetaminophen
Informed Consent
Glucocorticoids
Alcoholism
Pregnant Women
Hypersensitivity
Body Mass Index
Randomized Controlled Trials
Placebos
Research Personnel

Citer dette

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title = "DEX-2-TKA - DEXamethasone twice for pain treatment after Total Knee Arthroplasty. A protocol for a randomized, blinded, three-group multicentre clinical trial",
abstract = "BACKGROUND: Multimodal analgesia is considered the leading principle for post-operative pain treatment, but no gold standard after total knee arthroplasty (TKA) exists.AIM: To investigate the beneficial and harmful effects of one or two doses of 24 mg intravenous dexamethasone (DXM) as part of a multimodal analgesic regimen (paracetamol, NSAID and perioperative local infiltration analgesia) after TKA. We hypothesize that addition of DXM will reduce post-operative opioid consumption.METHODS: DEXamethasone twice for pain treatment after TKA is a randomized, blinded, three-group multicentre clinical trial. Participants will be randomized to one of three groups: placebo, single dose of DXM or two consecutive doses of DXM. Participants, treatment providers and investigators will be blinded to the allocated intervention. The primary outcome is total opioid consumption (units of morphine equivalents) 0-48 hours post-operatively.INCLUSION CRITERIA: unilateral, primary TKA; age ≥18 years; American Society of Anesthesiologists-Score 1-3; Body Mass Index ≥18 and ≤40; for women-not pregnant; and written informed consent.EXCLUSION CRITERIA: allergy or contraindications against trial medication; daily use of high dose opioid and/or use of methadone/transdermal opioids; daily use of systemic glucocorticoids; dysregulated diabetes; and patients suffering from alcohol and/or drug abuse. Four-hundred-and-eighty-six eligible participants are needed to detect or discard a difference of 10 mg morphine equivalents 0-48 hours post-operatively maintaining a familywise error rate of 0.05 and a power of 90{\%} for the three possible pairwise comparisons.DISCUSSION: Recruiting is planned to commence September 2018 and expected to finish March 2020.TRIAL REGISTRATION: EudraCT: 2018-001099-39 (08/06-18); ClinicalTrials.gov: NCT03506789 (24/04-2019). Editorial Comment This is the protocol for the largest randomized clinical trial investigating the effect of one or two doses of dexamethasones on pain treatment after total knee arthroplasty. Due to the pragmatic and rigerous design this study will deliver results of high quality and external validity.",
author = "Gasbjerg, {Kasper Smidt} and Daniel H{\"a}gi-Pedersen and Lunn, {Troels Haxholdt} and Jakobsen, {Janus Christian} and S{\o}ren Overgaard and Pedersen, {Niels Anker} and Jens Bagger and Peter Lindholm and Stig Brorson and Schr{\o}der, {Henrik Morville} and Thybo, {Kasper H{\o}jgaard} and Ole Mathiesen",
note = "{\circledC} 2019 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.",
year = "2019",
month = "9",
day = "22",
doi = "10.1111/aas.13481",
language = "English",
journal = "Acta Anaesthesiologica Scandinavica",
issn = "0001-5172",
publisher = "Wiley-Blackwell",

}

DEX-2-TKA - DEXamethasone twice for pain treatment after Total Knee Arthroplasty. A protocol for a randomized, blinded, three-group multicentre clinical trial. / Gasbjerg, Kasper Smidt; Hägi-Pedersen, Daniel; Lunn, Troels Haxholdt; Jakobsen, Janus Christian; Overgaard, Søren; Pedersen, Niels Anker; Bagger, Jens; Lindholm, Peter; Brorson, Stig; Schrøder, Henrik Morville; Thybo, Kasper Højgaard; Mathiesen, Ole.

I: Acta Anaesthesiologica Scandinavica, 22.09.2019.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - DEX-2-TKA - DEXamethasone twice for pain treatment after Total Knee Arthroplasty. A protocol for a randomized, blinded, three-group multicentre clinical trial

AU - Gasbjerg, Kasper Smidt

AU - Hägi-Pedersen, Daniel

AU - Lunn, Troels Haxholdt

AU - Jakobsen, Janus Christian

AU - Overgaard, Søren

AU - Pedersen, Niels Anker

AU - Bagger, Jens

AU - Lindholm, Peter

AU - Brorson, Stig

AU - Schrøder, Henrik Morville

AU - Thybo, Kasper Højgaard

AU - Mathiesen, Ole

N1 - © 2019 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

PY - 2019/9/22

Y1 - 2019/9/22

N2 - BACKGROUND: Multimodal analgesia is considered the leading principle for post-operative pain treatment, but no gold standard after total knee arthroplasty (TKA) exists.AIM: To investigate the beneficial and harmful effects of one or two doses of 24 mg intravenous dexamethasone (DXM) as part of a multimodal analgesic regimen (paracetamol, NSAID and perioperative local infiltration analgesia) after TKA. We hypothesize that addition of DXM will reduce post-operative opioid consumption.METHODS: DEXamethasone twice for pain treatment after TKA is a randomized, blinded, three-group multicentre clinical trial. Participants will be randomized to one of three groups: placebo, single dose of DXM or two consecutive doses of DXM. Participants, treatment providers and investigators will be blinded to the allocated intervention. The primary outcome is total opioid consumption (units of morphine equivalents) 0-48 hours post-operatively.INCLUSION CRITERIA: unilateral, primary TKA; age ≥18 years; American Society of Anesthesiologists-Score 1-3; Body Mass Index ≥18 and ≤40; for women-not pregnant; and written informed consent.EXCLUSION CRITERIA: allergy or contraindications against trial medication; daily use of high dose opioid and/or use of methadone/transdermal opioids; daily use of systemic glucocorticoids; dysregulated diabetes; and patients suffering from alcohol and/or drug abuse. Four-hundred-and-eighty-six eligible participants are needed to detect or discard a difference of 10 mg morphine equivalents 0-48 hours post-operatively maintaining a familywise error rate of 0.05 and a power of 90% for the three possible pairwise comparisons.DISCUSSION: Recruiting is planned to commence September 2018 and expected to finish March 2020.TRIAL REGISTRATION: EudraCT: 2018-001099-39 (08/06-18); ClinicalTrials.gov: NCT03506789 (24/04-2019). Editorial Comment This is the protocol for the largest randomized clinical trial investigating the effect of one or two doses of dexamethasones on pain treatment after total knee arthroplasty. Due to the pragmatic and rigerous design this study will deliver results of high quality and external validity.

AB - BACKGROUND: Multimodal analgesia is considered the leading principle for post-operative pain treatment, but no gold standard after total knee arthroplasty (TKA) exists.AIM: To investigate the beneficial and harmful effects of one or two doses of 24 mg intravenous dexamethasone (DXM) as part of a multimodal analgesic regimen (paracetamol, NSAID and perioperative local infiltration analgesia) after TKA. We hypothesize that addition of DXM will reduce post-operative opioid consumption.METHODS: DEXamethasone twice for pain treatment after TKA is a randomized, blinded, three-group multicentre clinical trial. Participants will be randomized to one of three groups: placebo, single dose of DXM or two consecutive doses of DXM. Participants, treatment providers and investigators will be blinded to the allocated intervention. The primary outcome is total opioid consumption (units of morphine equivalents) 0-48 hours post-operatively.INCLUSION CRITERIA: unilateral, primary TKA; age ≥18 years; American Society of Anesthesiologists-Score 1-3; Body Mass Index ≥18 and ≤40; for women-not pregnant; and written informed consent.EXCLUSION CRITERIA: allergy or contraindications against trial medication; daily use of high dose opioid and/or use of methadone/transdermal opioids; daily use of systemic glucocorticoids; dysregulated diabetes; and patients suffering from alcohol and/or drug abuse. Four-hundred-and-eighty-six eligible participants are needed to detect or discard a difference of 10 mg morphine equivalents 0-48 hours post-operatively maintaining a familywise error rate of 0.05 and a power of 90% for the three possible pairwise comparisons.DISCUSSION: Recruiting is planned to commence September 2018 and expected to finish March 2020.TRIAL REGISTRATION: EudraCT: 2018-001099-39 (08/06-18); ClinicalTrials.gov: NCT03506789 (24/04-2019). Editorial Comment This is the protocol for the largest randomized clinical trial investigating the effect of one or two doses of dexamethasones on pain treatment after total knee arthroplasty. Due to the pragmatic and rigerous design this study will deliver results of high quality and external validity.

U2 - 10.1111/aas.13481

DO - 10.1111/aas.13481

M3 - Journal article

JO - Acta Anaesthesiologica Scandinavica

JF - Acta Anaesthesiologica Scandinavica

SN - 0001-5172

ER -