The Effect of Dexamethasone on Pain After Total Knee Replacement Surgery

Pain, Postoperative Clinical Trial

Official title:

The Effect of Intravenous Single-dose Dexamethasone on Pain After Total Knee Replacement Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03034733
• Other study ID #: Polvitepdexa 24052016
• Status: Terminated
• Phase: Phase 4
• Start date: February 15, 2017
• Est. completion date: January 31, 2018

Study information

• Verified date: November 2018
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Total knee arthroplasty causes considerable pain. Multimodal analgesia and peripheral nerve blocks are used for treatment of pain. Some studies suggest that glucocorticoids alleviate postoperative pain. The optimal dose of dexamethasone in treatment of postoperative pain is not known. Studies on this subject in patients with total knee replacement are sparse. Potential side-effects of dexamethasone (hyperglycemia, wound infection) need to be studied.

Patients coming for primary knee replacement surgery are enrolled. The patients in each study group receive multimodal therapy for postoperative pain: etoricoxib, paracetamol, gabapentin and oxycodone. A single dose of intravenous dexamethasone (0,15 mg/kg or 0,25 mg/kg) or a placebo (saline) is administered to the patient during the operation. The effect of dexamethasone on postoperative pain is observed: main outcome is dynamic pain at 24 h postoperatively. The extent of inflammatory reaction is measured (CRP). Serial blood glucose measurements are done.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: January 31, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• primary total knee replacement surgery

• ASA (american society of anesthesiologists) class 1-3

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Arthroplasty, Knee Replacement
• Pain, Postoperative

Intervention

Drug:
• Dexamethasone
intravenous dexamethasone, two groups: 0,15 mg/kg, 0,25 mg/kg
• Sodium Chloride, (24)NaCl 0,9%
intravenous placebo

Locations

Country	Name	City	State
Finland	Oulu University Hospital	Oulu	OYS

Sponsors (1)

Lead Sponsor	Collaborator
University of Oulu

Country where clinical trial is conducted

Finland, 

References & Publications (16)

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. — View Citation

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. Review. — View Citation

Gilron I. Corticosteroids in postoperative pain management: future research directions for a multifaceted therapy. Acta Anaesthesiol Scand. 2004 Nov;48(10):1221-2. — View Citation

Holte K, Kehlet H. Perioperative single-dose glucocorticoid administration: pathophysiologic effects and clinical implications. J Am Coll Surg. 2002 Nov;195(5):694-712. Review. — View Citation

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. — View Citation

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. — View Citation

Kehlet H. Glucocorticoids for peri-operative analgesia: how far are we from general recommendations? Acta Anaesthesiol Scand. 2007 Oct;51(9):1133-5. — View Citation

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. — View Citation

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. Review. — View Citation

Lunn TH, Kristensen BB, Andersen LØ, 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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	blood glucose, mmol/l	blood sample	at preoperative visit, at induction of anesthesia, postoperatively: at 2 hours, at 8 hours, at 24 hours, at 32 hours, at 48 hours
Other	inflammatory reaction, c-reactive protein (CRP)	blood sample	preoperative, postoperatively: at 24 hours, 48 hours
Other	wound complication, yes/no	wound complication, yes/no	postoperatively up to 90 days
Other	wound infection, yes/no	wound infection, yes/no	postoperatively up to 90 days
Primary	pain during walking, NRS 0-10	NRS (numerical rating scale: 0=no pain, 10 = worst possible pain)	at 24 hours postoperatively
Secondary	pain at rest, NRS 0-10	NRS (numerical rating scale: 0=no pain, 10 = worst possible pain)	preoperatively, postoperatively: at 2 hours, at 8 hours,at 24 hours, at 32 hours, at 48 hours, seventh postoperative day
Secondary	consumption of intravenous oxycodone, milligrams/kilogram body weight	cumulative dose of oxycodone administered with a PCA (patient-controlled analgesia)-device	postoperatively: at 2 hours, at 8 hours, at 24 hours, at 48 hours
Secondary	nausea, NRS 0-10	NRS (numerical rating scale: 0=no nausea, 10 = worst possible nausea)	postoperatively: at 2 hours, at 8 hours,at 24 hours, at 32 hours, at 48 hours
Secondary	general wellbeing, NRS 0-10	NRS (numerical rating scale: 0=worst, 10 = best)	postoperatively: at 2 hours, at 8 hours,at 24 hours, at 32 hours, at 48 hours
Secondary	quality of sleep, NRS 0-10	NRS (numerical rating scale: 0=worst, 10 = best)	postoperatively at 24 hours, at 48 hours
Secondary	time to achieve discharge criteria, hours	time to achieve discharge criteria, hours	postoperatively: at 24 hours, at 48 hours, at 72 hours, at 96 hours
Secondary	pain during walking, NRS 0-10	NRS (numerical rating scale: 0=no pain, 10 = worst possible pain)	preoperatively, postoperatively: at 8 hours, at 48 hours, seventh postoperative day
Secondary	vomiting, yes/no	vomiting, yes/no	postoperatively: at 2 hours, at 8 hours,at 24 hours, at 32 hours, at 48 hours