Repeat Dose Steroid to Prevent Pain Relapse After Total Knee Arthroplasty in Patients With High Pain Response
NCT ID: NCT05563155
Last Updated: 2024-06-28
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
110 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-11-01
Study Completion Date
2024-03-22
Brief Summary
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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.
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.
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Detailed Description
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Total hip and knee arthroplasty (THA/TKA) are frequently performed procedures and are expected to increase in numbers along with the growing elderly population the next decade.
Total Knee Arthroplasty (TKA) is suitable for FAST-TRACK surgery, and is often performed as outpatient surgery with no hospital overnight stay.
Challenges in FAST-TRACK surgery include postoperative pain, nausea and vomiting (PONV), complications due to rescue-analgesics and surgical complications.
Pain is a well-known clinical problem, with up to 75% of TKA patients experiencing moderate to severe pain the first day after surgery, and 30-40% still experiencing moderate to severe pain 2 weeks after surgery, potentially delaying ambulation and recovery within the first weeks.
The role of severe acute postoperative pain upon the development of chronic pain is debatable, but important.
Data from our recently finished study in High Pain Responders (HPR), defined as patients with a score above 20 on the Pain Catastrophizing Scale (PCS), receiving preoperative high dose dexamethasone (Nielsen et al.: IN PREPARATION, clinicaltrials.gov ID NCT03763734, EudraCT 2018-002635-23, VEK H-18034778) found a persistent moderate to severe pain in 40 % of patients, at time 48 hours after surgery, corresponding to the time when the physiological effect of our dexamethasone intervention declines.
Moderate to severe pain (Visual analogue scale (VAS \>30)) 24 hours postoperatively during a 5-meter walk test was associated with relapse pain at 48 hours.
Other studies have made attempts of investigating the effect of a repeated dose of steroids after TKA and Total Hip Arthroplasty (THA), but all have done so with a postoperative injection of low dose steroids. No previous studies have, to our knowledge, investigated the effects of repeat dosing after a preoperative high dose of steroid, and none focused on patients selected by their postoperative pain response. In spite of many studies and systematic reviews on the subject, the optimal timing and dose for steroid-intervention in TKA in different patient groups is still inadequately understood
The study conduct with a repeat moderate dose of steroids given as an oral tablet at 9-11 pm on the day after TKA surgery in patients receiving preoperative high dose steroids, who have a high postoperative pain response, in a FAST-TRACK perioperative setting. Oral administration of the repeat dose will allow for possible early discharge in future clinical settings.
The hypothesis is that a repeat moderate dose of glucocorticoid will reduce the postoperative pain on postoperative day 2 and cumulated pain day 2-3 after TKA surgery, when compared to single high dose preoperatively.
Total Knee Arthroplasty (TKA) is suitable for FAST-TRACK surgery, and is often performed as outpatient surgery with no hospital overnight stay.
Challenges in FAST-TRACK surgery include postoperative pain, nausea and vomiting (PONV), complications due to rescue-analgesics and surgical complications.
Pain is a well-known clinical problem, with up to 75% of TKA patients experiencing moderate to severe pain the first day after surgery, and 30-40% still experiencing moderate to severe pain 2 weeks after surgery, potentially delaying ambulation and recovery within the first weeks.
The role of severe acute postoperative pain upon the development of chronic pain is debatable, but important.
Data from our recently finished study in High Pain Responders (HPR), defined as patients with a score above 20 on the Pain Catastrophizing Scale (PCS), receiving preoperative high dose dexamethasone (Nielsen et al.: IN PREPARATION, clinicaltrials.gov ID NCT03763734, EudraCT 2018-002635-23, VEK H-18034778) found a persistent moderate to severe pain in 40 % of patients, at time 48 hours after surgery, corresponding to the time when the physiological effect of our dexamethasone intervention declines.
Moderate to severe pain (Visual analogue scale (VAS \>30)) 24 hours postoperatively during a 5-meter walk test was associated with relapse pain at 48 hours.
Other studies have made attempts of investigating the effect of a repeated dose of steroids after TKA and Total Hip Arthroplasty (THA), but all have done so with a postoperative injection of low dose steroids. No previous studies have, to our knowledge, investigated the effects of repeat dosing after a preoperative high dose of steroid, and none focused on patients selected by their postoperative pain response. In spite of many studies and systematic reviews on the subject, the optimal timing and dose for steroid-intervention in TKA in different patient groups is still inadequately understood
The study conduct with a repeat moderate dose of steroids given as an oral tablet at 9-11 pm on the day after TKA surgery in patients receiving preoperative high dose steroids, who have a high postoperative pain response, in a FAST-TRACK perioperative setting. Oral administration of the repeat dose will allow for possible early discharge in future clinical settings.
The hypothesis is that a repeat moderate dose of glucocorticoid will reduce the postoperative pain on postoperative day 2 and cumulated pain day 2-3 after TKA surgery, when compared to single high dose preoperatively.
Conditions
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Post Operative Pain, Acute
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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.
Group 1: Postoperative placebo tablet on day 1 after surgery.
Group 2: Postoperative dexamethasone 24 mg tablet on day 1 after surgery.
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
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.
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.
Study Groups
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Placebo tablet on day 1 after surgery given as one single dose.
Control Group (CG):
Intervention: Postoperative oral placebo tablet on day 1 after surgery given as one single dose.
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Placebo tablet given on day 1 after surgery.
Dexamethasone 24 mg on day 1 after surgery given as one single dose.
Repeat Dose Group (RDG):
Intervention: Postoperative oral dexamethasone 24 mg on day 1 after surgery given as one single dose.
Group Type
ACTIVE_COMPARATOR
Dexamethasone 24 mg
Intervention Type
DRUG
Dexamethasone 24 mg on day 1 after surgery.
Interventions
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Dexamethasone 24 mg
Dexamethasone 24 mg on day 1 after surgery.
Intervention Type
DRUG
Placebo
Placebo tablet given on day 1 after surgery.
Intervention Type
DRUG
Other Intervention Names
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Dexa-ratiopharm
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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.
* Pregnancy: No women with suspected or proven pregnancy are eligible for inclusion. The following will be considered as safe contraception: intrauterine device or hormonal contraception. For women aged between 40-50 years, a urine HCG test for pregnancy will be performed.
* 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.
* Pregnancy: No women with suspected or proven pregnancy are eligible for inclusion. The following will be considered as safe contraception: intrauterine device or hormonal contraception. For women aged between 40-50 years, a urine HCG test for pregnancy will be performed.
Minimum Eligible Age
40 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Hvidovre University Hospital
OTHER
Sponsor Role
collaborator
Vejle Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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Vejle Hospital. Orthopedic Surgery Department. Clinical Research Unit
Vejle, , Denmark
Site Status
Countries
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Denmark
References
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Pabinger C, Lothaller H, Portner N, Geissler A. Projections of hip arthroplasty in OECD countries up to 2050. Hip Int. 2018 Sep;28(5):498-506. doi: 10.1177/1120700018757940. Epub 2018 May 21.
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Erivan R, Villatte G, Dartus J, Reina N, Descamps S, Boisgard S. Progression and projection for hip surgery in France, 2008-2070: Epidemiologic study with trend and projection analysis. Orthop Traumatol Surg Res. 2019 Nov;105(7):1227-1235. doi: 10.1016/j.otsr.2019.07.021. Epub 2019 Oct 9.
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BACKGROUND
Romanini E, Decarolis F, Luzi I, Zanoli G, Venosa M, Laricchiuta P, Carrani E, Torre M. Total knee arthroplasty in Italy: reflections from the last fifteen years and projections for the next thirty. Int Orthop. 2019 Jan;43(1):133-138. doi: 10.1007/s00264-018-4165-7. Epub 2018 Oct 6.
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BACKGROUND
Sloan M, Premkumar A, Sheth NP. Projected Volume of Primary Total Joint Arthroplasty in the U.S., 2014 to 2030. J Bone Joint Surg Am. 2018 Sep 5;100(17):1455-1460. doi: 10.2106/JBJS.17.01617.
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BACKGROUND
Gromov K, Kjaersgaard-Andersen P, Revald P, Kehlet H, Husted H. Feasibility of outpatient total hip and knee arthroplasty in unselected patients. Acta Orthop. 2017 Oct;88(5):516-521. doi: 10.1080/17453674.2017.1314158. Epub 2017 Apr 20.
Reference Type
BACKGROUND
Chan EY, Blyth FM, Nairn L, Fransen M. Acute postoperative pain following hospital discharge after total knee arthroplasty. Osteoarthritis Cartilage. 2013 Sep;21(9):1257-63. doi: 10.1016/j.joca.2013.06.011.
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BACKGROUND
Andersen LO, Gaarn-Larsen L, Kristensen BB, Husted H, Otte KS, Kehlet H. Subacute pain and function after fast-track hip and knee arthroplasty. Anaesthesia. 2009 May;64(5):508-13. doi: 10.1111/j.1365-2044.2008.05831.x.
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BACKGROUND
Lavand'homme P. Transition from acute to chronic pain after surgery. Pain. 2017 Apr;158 Suppl 1:S50-S54. doi: 10.1097/j.pain.0000000000000809. No abstract available.
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BACKGROUND
Lavand'homme PM, Grosu I, France MN, Thienpont E. Pain trajectories identify patients at risk of persistent pain after knee arthroplasty: an observational study. Clin Orthop Relat Res. 2014 May;472(5):1409-15. doi: 10.1007/s11999-013-3389-5.
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BACKGROUND
Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.
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BACKGROUND
Sullivan M, Bishop S, Pivik J. The pain catastrophizing scale: development and validation. Psychol Assess 1995; 7: 524-32
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BACKGROUND
Khan RS, Ahmed K, Blakeway E, Skapinakis P, Nihoyannopoulos L, Macleod K, Sevdalis N, Ashrafian H, Platt M, Darzi A, Athanasiou T. Catastrophizing: a predictive factor for postoperative pain. Am J Surg. 2011 Jan;201(1):122-31. doi: 10.1016/j.amjsurg.2010.02.007. Epub 2010 Sep 15.
Reference Type
BACKGROUND
Xu H, Zhang S, Xie J, Lei Y, Cao G, Pei F. Multiple Doses of Perioperative Dexamethasone Further Improve Clinical Outcomes After Total Knee Arthroplasty: A Prospective, Randomized, Controlled Study. J Arthroplasty. 2018 Nov;33(11):3448-3454. doi: 10.1016/j.arth.2018.06.031. Epub 2018 Jul 4.
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BACKGROUND
Li D, Zhao J, Yang Z, Kang P, Shen B, Pei F. Multiple Low Doses of Intravenous Corticosteroids to Improve Early Rehabilitation in Total Knee Arthroplasty: A Randomized Clinical Trial. J Knee Surg. 2019 Feb;32(2):171-179. doi: 10.1055/s-0038-1636506. Epub 2018 Mar 7.
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BACKGROUND
Xu B, Ma J, Huang Q, Huang ZY, Zhang SY, Pei FX. Two doses of low-dose perioperative dexamethasone improve the clinical outcome after total knee arthroplasty: a randomized controlled study. Knee Surg Sports Traumatol Arthrosc. 2018 May;26(5):1549-1556. doi: 10.1007/s00167-017-4506-x. Epub 2017 May 4.
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BACKGROUND
Dissanayake R, Du HN, Robertson IK, Ogden K, Wiltshire K, Mulford JS. Does Dexamethasone Reduce Hospital Readiness for Discharge, Pain, Nausea, and Early Patient Satisfaction in Hip and Knee Arthroplasty? A Randomized, Controlled Trial. J Arthroplasty. 2018 Nov;33(11):3429-3436. doi: 10.1016/j.arth.2018.07.013. Epub 2018 Jul 19.
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BACKGROUND
Kim JK, Ro DH, Lee HJ, Park JY, Han HS, Lee MC. Efficacy of Systemic Steroid Use Given One Day After Total Knee Arthroplasty for Pain and Nausea: A Randomized Controlled Study. J Arthroplasty. 2020 Jan;35(1):69-75. doi: 10.1016/j.arth.2019.08.026. Epub 2019 Aug 19.
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BACKGROUND
Lei YT, Xu B, Xie XW, Xie JW, Huang Q, Pei FX. The efficacy and safety of two low-dose peri-operative dexamethasone on pain and recovery following total hip arthroplasty: a randomized controlled trial. Int Orthop. 2018 Mar;42(3):499-505. doi: 10.1007/s00264-017-3537-8. Epub 2017 Jun 25.
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BACKGROUND
Lei Y, Huang Q, Xu B, Zhang S, Cao G, Pei F. Multiple Low-Dose Dexamethasone Further Improves Clinical Outcomes Following Total Hip Arthroplasty. J Arthroplasty. 2018 May;33(5):1426-1431. doi: 10.1016/j.arth.2017.11.057. Epub 2017 Dec 5.
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BACKGROUND
Kehlet H, Joshi GP. The systematic review/meta-analysis epidemic: a tale of glucocorticoid therapy in total knee arthroplasty. Anaesthesia. 2020 Jul;75(7):856-860. doi: 10.1111/anae.14946. Epub 2019 Dec 4. No abstract available.
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BACKGROUND
Riddle DL, Wade JB, Jiranek WA, Kong X. Preoperative pain catastrophizing predicts pain outcome after knee arthroplasty. Clin Orthop Relat Res. 2010 Mar;468(3):798-806. doi: 10.1007/s11999-009-0963-y. Epub 2009 Jul 8.
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BACKGROUND
Toner AJ, Ganeshanathan V, Chan MT, Ho KM, Corcoran TB. Safety of Perioperative Glucocorticoids in Elective Noncardiac Surgery: A Systematic Review and Meta-analysis. Anesthesiology. 2017 Feb;126(2):234-248. doi: 10.1097/ALN.0000000000001466.
Reference Type
BACKGROUND
Jorgensen CC, Pitter FT, Kehlet H; Lundbeck Foundation Center for Fast-track Hip and Knee Replacement Collaborative Group. Safety aspects of preoperative high-dose glucocorticoid in primary total knee replacement. Br J Anaesth. 2017 Aug 1;119(2):267-275. doi: 10.1093/bja/aex190.
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BACKGROUND
de la Motte L, Kehlet H, Vogt K, Nielsen CH, Groenvall JB, Nielsen HB, Andersen A, Schroeder TV, Lonn L. Preoperative methylprednisolone enhances recovery after endovascular aortic repair: a randomized, double-blind, placebo-controlled clinical trial. Ann Surg. 2014 Sep;260(3):540-8; discussion 548-9. doi: 10.1097/SLA.0000000000000895.
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BACKGROUND
Rupp M, Lau E, Kurtz SM, Alt V. Projections of Primary TKA and THA in Germany From 2016 Through 2040. Clin Orthop Relat Res. 2020 Jul;478(7):1622-1633. doi: 10.1097/CORR.0000000000001214.
Reference Type
RESULT
Springborg AH, Varnum C, Nielsen NI, Rasmussen LE, Kjaersgaard-Andersen P, Pleckaitiene L, Gromov K, Troelsen A, Kehlet H, Foss NB. Repeat-dose dexamethasone to prevent pain relapse after total knee arthroplasty in high-pain-response patients: A randomised, double-blind, placebo-controlled superiority trial. Eur J Anaesthesiol. 2025 Jul 1;42(7):599-608. doi: 10.1097/EJA.0000000000002189. Epub 2025 May 14.
Reference Type
DERIVED
Other Identifiers
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Repeat Dose
Identifier Type: -
Identifier Source: org_study_id
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