The Effect of Dexamethasone on Pain After Total Knee Replacement Surgery

NCT03034733 | Terminated Phase 4

• 1 other identifier: Polvitepdexa 24052016
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine, if a single-dose of dexamethasone given during the operation, alleviates pain after knee replacement surgery.

Conditions

Arthroplasty, Knee Replacement; Pain, Postoperative

Keywords

Arthroplasty; Knee Replacement; Pain, Postoperative; Glucocorticoids; Dexamethasone

Outcome Measures

Primary Outcomes (1)

• pain during walking, NRS 0-10

  NRS (numerical rating scale: 0=no pain, 10 = worst possible pain)

  at 24 hours postoperatively

Secondary Outcomes (8)

• pain at rest, NRS 0-10

  preoperatively, postoperatively: at 2 hours, at 8 hours,at 24 hours, at 32 hours, at 48 hours, seventh postoperative day

• consumption of intravenous oxycodone, milligrams/kilogram body weight

  postoperatively: at 2 hours, at 8 hours, at 24 hours, at 48 hours

• nausea, NRS 0-10

  postoperatively: at 2 hours, at 8 hours,at 24 hours, at 32 hours, at 48 hours

• general wellbeing, NRS 0-10

  postoperatively: at 2 hours, at 8 hours,at 24 hours, at 32 hours, at 48 hours

• quality of sleep, NRS 0-10

  postoperatively at 24 hours, at 48 hours

Other Outcomes (4)

• blood glucose, mmol/l

  at preoperative visit, at induction of anesthesia, postoperatively: at 2 hours, at 8 hours, at 24 hours, at 32 hours, at 48 hours

• inflammatory reaction, c-reactive protein (CRP)

  preoperative, postoperatively: at 24 hours, 48 hours

• wound complication, yes/no

  postoperatively up to 90 days

Study Arms (3)

dexamethasone 0,15 mg/kg

EXPERIMENTAL

single-dose intravenous dexamethasone 0,15 mg/kg, intraoperative

Drug: Dexamethasone

dexamethasone 0,25 mg/kg

EXPERIMENTAL

single-dose intravenous dexamethasone 0,25 mg/kg, intraoperative

Drug: Dexamethasone

Sodium Chloride, (24)NaCl 0,9%

PLACEBO COMPARATOR

single-dose intravenous saline, intraoperative

Drug: Sodium Chloride, (24)NaCl 0,9%

Interventions

Dexamethasone DRUG

intravenous dexamethasone, two groups: 0,15 mg/kg, 0,25 mg/kg

Also known as: Oradexon

dexamethasone 0,15 mg/kg; dexamethasone 0,25 mg/kg

Sodium Chloride, (24)NaCl 0,9% DRUG

intravenous placebo

Also known as: saline

Sodium Chloride, (24)NaCl 0,9%

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• primary total knee replacement surgery
• ASA (american society of anesthesiologists) class 1-3

You may not qualify if:

• severe coronary artery disease, heart failure, kidney failure
• insulin-dependent DM (diabetes mellitus), poorly controlled type II DM
• gastric/duodenal ulcer
• allergy/contra-indication for any drug used in the study
• corticosteroid use during last 3 months
• preoperative use of opioid drugs (excl. codeine, tramadol)
• neuropathy/sensory impairment of lower limbs
• lack of co-operation, e.g. inability to use a PCA (patient controlled analgesia)-device

Sponsors & Collaborators

• University of Oulu: lead

Study Sites (1)

Oulu University Hospital

Oulu, OYS, 90029, Finland

Location

Related Publications (16)

• Lunn TH, Kehlet H. Perioperative glucocorticoids in hip and knee surgery - benefit vs. harm? A review of randomized clinical trials. Acta Anaesthesiol Scand. 2013 Aug;57(7):823-34. doi: 10.1111/aas.12115. Epub 2013 Apr 15.

  PMID: 23581549 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.

  PMID: 23937923 BACKGROUND

• De Oliveira GS Jr, Almeida MD, Benzon HT, McCarthy RJ. Perioperative single dose systemic dexamethasone for postoperative pain: a meta-analysis of randomized controlled trials. Anesthesiology. 2011 Sep;115(3):575-88. doi: 10.1097/ALN.0b013e31822a24c2.

  PMID: 21799397 BACKGROUND

• Gilron I. Corticosteroids in postoperative pain management: future research directions for a multifaceted therapy. Acta Anaesthesiol Scand. 2004 Nov;48(10):1221-2. doi: 10.1111/j.1399-6576.2004.00581.x. No abstract available.

  PMID: 15504179 BACKGROUND

• Holte K, Kehlet H. Perioperative single-dose glucocorticoid administration: pathophysiologic effects and clinical implications. J Am Coll Surg. 2002 Nov;195(5):694-712. doi: 10.1016/s1072-7515(02)01491-6. No abstract available.

  PMID: 12437261 BACKGROUND

• Husted H, Lunn TH, Troelsen A, Gaarn-Larsen L, Kristensen BB, Kehlet H. Why still in hospital after fast-track hip and knee arthroplasty? Acta Orthop. 2011 Dec;82(6):679-84. doi: 10.3109/17453674.2011.636682. Epub 2011 Nov 9.

  PMID: 22066560 BACKGROUND

• Kehlet H. Glucocorticoids for peri-operative analgesia: how far are we from general recommendations? Acta Anaesthesiol Scand. 2007 Oct;51(9):1133-5. doi: 10.1111/j.1399-6576.2007.01459.x. No abstract available.

  PMID: 17850557 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.

  PMID: 23645340 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.

  PMID: 21131371 BACKGROUND

• Richards JE, Kauffmann RM, Zuckerman SL, Obremskey WT, May AK. Relationship of hyperglycemia and surgical-site infection in orthopaedic surgery. J Bone Joint Surg Am. 2012 Jul 3;94(13):1181-6. doi: 10.2106/JBJS.K.00193.

  PMID: 22760385 BACKGROUND

• Romundstad L, Breivik H, Niemi G, Helle A, Stubhaug A. Methylprednisolone intravenously 1 day after surgery has sustained analgesic and opioid-sparing effects. Acta Anaesthesiol Scand. 2004 Nov;48(10):1223-31. doi: 10.1111/j.1399-6576.2004.00480.x.

  PMID: 15504180 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.

  PMID: 16757774 BACKGROUND

• Sauerland S, Nagelschmidt M, Mallmann P, Neugebauer EA. Risks and benefits of preoperative high dose methylprednisolone in surgical patients: a systematic review. Drug Saf. 2000 Nov;23(5):449-61. doi: 10.2165/00002018-200023050-00007.

  PMID: 11085349 BACKGROUND

• Waldron NH, Jones CA, Gan TJ, Allen TK, Habib AS. Impact of perioperative dexamethasone on postoperative analgesia and side-effects: systematic review and meta-analysis. Br J Anaesth. 2013 Feb;110(2):191-200. doi: 10.1093/bja/aes431. Epub 2012 Dec 5.

  PMID: 23220857 BACKGROUND

• Smith C, Erasmus PJ, Myburgh KH. Endocrine and immune effects of dexamethasone in unilateral total knee replacement. J Int Med Res. 2006 Nov-Dec;34(6):603-11. doi: 10.1177/147323000603400605.

  PMID: 17294992 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.

  PMID: 18349202 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexamethasone; Sodium Chloride

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; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Matti Kyllönen, MD

  Oulu University Hospital

  PRINCIPAL INVESTIGATOR

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: January 3, 2017
• First Posted: January 27, 2017
• Study Start: February 15, 2017
• Primary Completion: January 31, 2018
• Study Completion: January 31, 2018
• Last Updated: November 29, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)