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This randomized, single surgeon, placebo controlled, double blind study will be conducted in order to investigate whether or not peri-operative high doses of intravenous glucocorticoids improve short-term functional outcome after direct anterior total hip arthroplasty. So far, it has been proven that high dose glucocorticoids reduce immediate post-operative pain and nausea, but no data exists on functional outcome during the first 6 weeks. Our hypothesis is that patients in the intervention group will follow a so-called "get ahead, stay ahead" principle and that glucocorticoids can be considered an important tool (adjuvant treatment) in the enhanced recovery pathway after THA with significant socio-economic implications.
Patients listed for a direct anterior total hip arthroplasty by a single surgeon will be recruited for this study and allocated to one of two groups:
Based on a power analysis both groups will consist of 35 patients each.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Current protocol | Experimental | "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. |
|
| Old protocol | Active Comparator | "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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High dose of peri-operative intravenous dexamethasone | Drug | 25mg aacidexam is administered during induction followed by 10mg on the ward after 12 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Steps | Number of steps as measured by a pedometer | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative nausea and vomiting | Post-operative nausea and vomiting Visual Analogue Scale scores | up to 1 week, 0-10, lower scores indicate better clinical outcome |
| Same day mobilization | Whether or not if was possible for the physiotherapists to mobilize the patient on the day of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stijn Ghijselings, MD | Universitaire Ziekenhuizen KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals of Leuven | Leuven | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17964352 | Background | Learmonth ID, Young C, Rorabeck C. The operation of the century: total hip replacement. Lancet. 2007 Oct 27;370(9597):1508-19. doi: 10.1016/S0140-6736(07)60457-7. | |
| 10475299 | Background | Macario A, Weinger M, Carney S, Kim A. Which clinical anesthesia outcomes are important to avoid? The perspective of patients. Anesth Analg. 1999 Sep;89(3):652-8. doi: 10.1097/00000539-199909000-00022. |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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A randomized, single surgeon, placebo controlled, double blind study using two parallel study groups
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An anesthetist or study nurse not involved in further care of the patient nor in the study will prepare the medication to administered based on the allocated group. The first syringe with either 5 or 25 mg of Aacidexam will be administered during induction. The second syringe will go with the patient to the ward and will be administered 12 hours after the surgery by the (blinded) ward nurse. The patient will not be made aware of what has been administered.
|
| Low dose of peri-operative intravenous dexamethasone | Drug | 10mg aacidexam is administered during induction followed by placebo on the ward after 12 hours |
|
|
| 1 day (yes or no) |
| Clinical milestones | Time to achieve certain clinical milestones, e.g. climbing stairs, driving a car, etc | 6 weeks |
| Oxford Hip Score | Patients Reported Outcome Measures | 6 weeks |
| Western Ontario and McMaster Universities Osteoarthritis Index | Patients Reported Outcome Measures | 6 weeks |
| Hip dysfunction and Osteoarthritis Outcome Score | Patients Reported Outcome Measures | 6 weeks |
| Forgotten Joint Score | Patients Reported Outcome Measures | 6 weeks |
| Short Form 36 | Patients Reported Outcome Measures | 6 weeks |
| Fatigue Severity Scale | Patients Reported Outcome Measures | 6 weeks |
| Groningen Activity Restriction Scale | Patients Reported Outcome Measures | 6 weeks |
| Pain scores | Visual Analogue Scale scores during the day, the night and during exercises | 6 weeks, 0-10, lower scores indicate better clinical outcome |
| Stiffness | Visual Analogue Scale scores | 6 weeks, 0-10, lower scores indicate better clinical outcome |
| Use of Analgesia | The use of analgesia such as paracetamol (acetominophen), NSAIDs, and morphine(like) substances | 6 weeks |
| Use of Anti-emetics | The use anti-emetics to reduce direct post-operative nausea | Up to 1 week |
| Complications | The occurrence of complications such as wound healing problems, infections, allergic reactions, venous thrombo-embolisms, etc | 6 weeks |
| Side effects | The occurrence of side-effects | 6 weeks |
| 24996539 | Background | 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. |
| 10740539 | Background | 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. |
| 16757774 | Background | Salerno A, Hermann R. Efficacy and safety of steroid use for postoperative pain relief. Update and review of the medical literature. J Bone Joint Surg Am. 2006 Jun;88(6):1361-72. doi: 10.2106/JBJS.D.03018. |
| 12917945 | Background | Choi PT, Bhandari M, Scott J, Douketis J. Epidural analgesia for pain relief following hip or knee replacement. Cochrane Database Syst Rev. 2003;2003(3):CD003071. doi: 10.1002/14651858.CD003071. |
| 27248332 | Background | Moskal JT, Capps SG. Meta-analysis of Intravenous Tranexamic Acid in Primary Total Hip Arthroplasty. Orthopedics. 2016 Sep 1;39(5):e883-92. doi: 10.3928/01477447-20160526-02. Epub 2016 Jun 1. |
| 25599296 | Background | Hojer Karlsen AP, Geisler A, Petersen PL, Mathiesen O, Dahl JB. Postoperative pain treatment after total hip arthroplasty: a systematic review. Pain. 2015 Jan;156(1):8-30. doi: 10.1016/j.pain.0000000000000003. |
| 23709186 | Background | Nanni M, Perna F, Calamelli C, Donati D, Ferrara O, Parlato A, D'Arienzo M, Faldini C. Wound drainages in total hip arthroplasty: to use or not to use? Review of the literature on current practice. Musculoskelet Surg. 2013 Aug;97(2):101-7. doi: 10.1007/s12306-013-0270-3. Epub 2013 May 25. |
| 31251213 | Background | Villatte G, Mathonnet M, Villeminot J, Savary M, Theissen A, Ostermann S, Erivan R, Raynaud-Simon A, Slim K. [Interest of enhanced recovery programs in the elderly during total hip arthroplasty A systematic review]. Geriatr Psychol Neuropsychiatr Vieil. 2019 Sep 1;17(3):234-242. doi: 10.1684/pnv.2019.0796. French. |
| 18349202 | Background | Kardash KJ, Sarrazin F, Tessler MJ, Velly AM. Single-dose dexamethasone reduces dynamic pain after total hip arthroplasty. Anesth Analg. 2008 Apr;106(4):1253-7, table of contents. doi: 10.1213/ANE.0b013e318164f319. |
| 18653493 | Background | 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. |
| 19224304 | Background | 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. |
| 19734790 | Background | 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. |
| 21054459 | Background | 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. |
| 20839434 | Background | 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. |
| 21131371 | Background | 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. |
| 22986420 | Background | 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. |
| 23937923 | Background | 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. |
| 23645340 | Background | Koh IJ, Chang CB, Lee JH, Jeon YT, Kim TK. Preemptive low-dose dexamethasone reduces postoperative emesis and pain after TKA: a randomized controlled study. Clin Orthop Relat Res. 2013 Sep;471(9):3010-20. doi: 10.1007/s11999-013-3032-5. Epub 2013 May 4. |
| 25565656 | Background | 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. |
| 25680452 | Background | Sculco PK, Pagnano MW. Perioperative solutions for rapid recovery joint arthroplasty: get ahead and stay ahead. J Arthroplasty. 2015 Apr;30(4):518-20. doi: 10.1016/j.arth.2015.01.036. Epub 2015 Jan 30. |
| 28631144 | Background | Xu B, Ma J, Huang Q, Huang ZY, Zhang SY, Pei FX. Erratum to: 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 Jun;26(6):1879. doi: 10.1007/s00167-017-4593-8. No abstract available. |
| 28647788 | 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. |
| 29258763 | 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. |
| 30078660 | 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. |
| 27803219 | Background | 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. |
| D012216 |
| Rheumatic Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |