Effect of Peri-operative Glucocorticoids on Short-term Functional Outcome After THA
NCT ID: NCT04317872
Last Updated: 2025-04-15
Study Results
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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COMPLETED
NA
71 participants
INTERVENTIONAL
2020-07-01
2024-05-03
Brief Summary
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Detailed Description
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1. intervention group: 25 grams of iv dexamethasone at induction followed by 10 mg of iv dexamethasone 12 hours later
2. control group: 5 grams of iv dexamethasone at induction followed by placebo 12 hours later Both patients and surgeons will be blinded. Primary outcome measure will be number of steps during the first 6 weeks as measured by a pedometer. Secondary outcome measures will be side effects, complications, Patient Reported Outcome Measures, pain, nausea, stiffness, achievement of clinical milestones and use of analgesia/anti-emetics. This data will be collected using a tailor made application for a smartphone or tablet and data collecting will start one week before surgery until 6 weeks after surgery.
Based on a power analysis both groups will consist of 35 patients each.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Current protocol
"Current protocol": patients will receive a single shot of 25mg of aacidexam iv (5cc) at induction. After 12 hours these patients will another shot of 10mg of aacidexam iv (2cc) on the ward.
High dose of peri-operative intravenous dexamethasone
25mg aacidexam is administered during induction followed by 10mg on the ward after 12 hours
Old protocol
"Old protocol": patients will receive a single shot of 5mg of aacidexam iv at induction (5cc). After arrival 12 hours these patients will receive a placebo, i.e. a shot of 2 cc of NaCl 0.9% iv (Mini-Plasco van B. Braun).
Low dose of peri-operative intravenous dexamethasone
10mg aacidexam is administered during induction followed by placebo on the ward after 12 hours
Interventions
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High dose of peri-operative intravenous dexamethasone
25mg aacidexam is administered during induction followed by 10mg on the ward after 12 hours
Low dose of peri-operative intravenous dexamethasone
10mg aacidexam is administered during induction followed by placebo on the ward after 12 hours
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Aged 18 years and above (including women of child bearing age)
* Able to provide informed consent
Exclusion Criteria
* Known alcohol or drug abuse
* Known allergy for glucocorticoids
* Administration of any glucocorticoids in the last three months
* Usage of strong analgesia (such as lyrica or oxycodone) as regular medication
* Usage of medication with anticipated interactions with glucocorticoids
* Known gastric ulcer
* Insulin dependent diabetes mellitus
* Severe heart disease (NYHA \> 2)
* Liver or renal failure
* Systemic rheumatoid diseases
* Insufficient understanding of the Dutch language
* Unable to provide informed consent
* Pre-operative use of walking aids
* Gross anatomical deformities
* Significant intra-operative complications such as periprosthetic fracture
18 Years
ALL
No
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Principal Investigators
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Stijn Ghijselings, MD
Role: PRINCIPAL_INVESTIGATOR
Universitaire Ziekenhuizen KU Leuven
Locations
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University Hospitals of Leuven
Leuven, , Belgium
Countries
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References
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Marques EM, Jones HE, Elvers KT, Pyke M, Blom AW, Beswick AD. Local anaesthetic infiltration for peri-operative pain control in total hip and knee replacement: systematic review and meta-analyses of short- and long-term effectiveness. BMC Musculoskelet Disord. 2014 Jul 5;15:220. doi: 10.1186/1471-2474-15-220.
Myles PS, Williams DL, Hendrata M, Anderson H, Weeks AM. Patient satisfaction after anaesthesia and surgery: results of a prospective survey of 10,811 patients. Br J Anaesth. 2000 Jan;84(1):6-10. doi: 10.1093/oxfordjournals.bja.a013383.
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Mathiesen O, Jacobsen LS, Holm HE, Randall S, Adamiec-Malmstroem L, Graungaard BK, Holst PE, Hilsted KL, Dahl JB. Pregabalin and dexamethasone for postoperative pain control: a randomized controlled study in hip arthroplasty. Br J Anaesth. 2008 Oct;101(4):535-41. doi: 10.1093/bja/aen215. Epub 2008 Jul 23.
Bergeron SG, Kardash KJ, Huk OL, Zukor DJ, Antoniou J. Perioperative dexamethasone does not affect functional outcome in total hip arthroplasty. Clin Orthop Relat Res. 2009 Jun;467(6):1463-7. doi: 10.1007/s11999-009-0733-x. Epub 2009 Feb 18.
Rasmussen ML, Mathiesen O, Dierking G, Christensen BV, Hilsted KL, Larsen TK, Dahl JB. Multimodal analgesia with gabapentin, ketamine and dexamethasone in combination with paracetamol and ketorolac after hip arthroplasty: a preliminary study. Eur J Anaesthesiol. 2010 Apr;27(4):324-30. doi: 10.1097/EJA.0b013e328331c71d.
Miyagawa Y, Ejiri M, Kuzuya T, Osada T, Ishiguro N, Yamada K. Methylprednisolone reduces postoperative nausea in total knee and hip arthroplasty. J Clin Pharm Ther. 2010 Dec;35(6):679-84. doi: 10.1111/j.1365-2710.2009.01141.x.
Jiang J, Wang H, Wang Y. [Clinical study on effect of dexamethasone in preventing fat embolism syndrome after cemented hip arthroplasty]. Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi. 2010 Aug;24(8):913-6. Chinese.
Lunn TH, Kristensen BB, Andersen LO, Husted H, Otte KS, Gaarn-Larsen L, Kehlet H. Effect of high-dose preoperative methylprednisolone on pain and recovery after total knee arthroplasty: a randomized, placebo-controlled trial. Br J Anaesth. 2011 Feb;106(2):230-8. doi: 10.1093/bja/aeq333. Epub 2010 Dec 3.
Lunn TH, Andersen LO, Kristensen BB, Husted H, Gaarn-Larsen L, Bandholm T, Ladelund S, Kehlet H. Effect of high-dose preoperative methylprednisolone on recovery after total hip arthroplasty: a randomized, double-blind, placebo-controlled trial. Br J Anaesth. 2013 Jan;110(1):66-73. doi: 10.1093/bja/aes345. Epub 2012 Sep 17.
Backes JR, Bentley JC, Politi JR, Chambers BT. Dexamethasone reduces length of hospitalization and improves postoperative pain and nausea after total joint arthroplasty: a prospective, randomized controlled trial. J Arthroplasty. 2013 Sep;28(8 Suppl):11-7. doi: 10.1016/j.arth.2013.05.041. Epub 2013 Aug 9.
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McLawhorn AS, Beathe J, YaDeau J, Buschiazzo V, Purdue PE, Ma Y, Sculco TP, Jules-Elysee K. Effects of steroids on thrombogenic markers in patients undergoing unilateral total knee arthroplasty: a prospective, double-blind, randomized controlled trial. J Orthop Res. 2015 Mar;33(3):412-6. doi: 10.1002/jor.22776. Epub 2015 Jan 6.
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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.
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.
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.
Toogood PA, Abdel MP, Spear JA, Cook SM, Cook DJ, Taunton MJ. The monitoring of activity at home after total hip arthroplasty. Bone Joint J. 2016 Nov;98-B(11):1450-1454. doi: 10.1302/0301-620X.98B11.BJJ-2016-0194.R1.
Other Identifiers
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S63584
Identifier Type: -
Identifier Source: org_study_id
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