Arthroplasty, Knee ReplacementPhase 4NCT03034733

The Effect of Dexamethasone on Pain After Total Knee Replacement Surgery

A Phase 4 study testing Dexamethasone and Sodium Chloride, (24)NaCl 0,9% in people with Arthroplasty, Knee Replacement and Pain, Postoperative, run by University of Oulu at 1 site in Finland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Arthroplasty, Knee Replacement, Pain, Postoperative
What is being tested?: Dexamethasone and Sodium Chloride, (24)NaCl 0,9%
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 27 participants
Where: 1 siteFinland
Study dates: 15 Feb 2017to 31 Jan 2018
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Finland1 site

Oulu University Hospital
Oulu, OYS, 90029

Other trials in Finland

About this study

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

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

Read the detailed 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.

Conditions: Arthroplasty, Knee Replacement, Pain, Postoperative
Being tested: Dexamethasone, Sodium Chloride, (24)NaCl 0,9%
Keywords: Arthroplasty, Knee Replacement, Pain, Postoperative, Glucocorticoids, Dexamethasone
Medical subject headings: Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DexamethasoneDrug
Also called Oradexon
intravenous dexamethasone, two groups: 0,15 mg/kg, 0,25 mg/kg
Sodium Chloride, (24)NaCl 0,9%Drug
Also called saline
intravenous placebo

Study groups in NCT03034733
Study group	Role	What they receive
dexamethasone 0,15 mg/kg	Experimental	single-dose intravenous dexamethasone 0,15 mg/kg, intraoperative Receives: Drug: Dexamethasone
dexamethasone 0,25 mg/kg	Experimental	single-dose intravenous dexamethasone 0,25 mg/kg, intraoperative Receives: Drug: Dexamethasone
Sodium Chloride, (24)NaCl 0,9%	Placebo comparator	single-dose intravenous saline, intraoperative Receives: Drug: Sodium Chloride, (24)NaCl 0,9%

What is being measured

The primary outcome is the main question the study is designed to answer.

pain during walking, NRS 0-10
NRS (numerical rating scale: 0=no pain, 10 = worst possible pain)
Measured: at 24 hours postoperatively

Secondary outcomes (8)

pain at rest, NRS 0-10
NRS (numerical rating scale: 0=no pain, 10 = worst possible pain)
Measured: 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
cumulative dose of oxycodone administered with a PCA (patient-controlled analgesia)-device
Measured: postoperatively: at 2 hours, at 8 hours, at 24 hours, at 48 hours
nausea, NRS 0-10
NRS (numerical rating scale: 0=no nausea, 10 = worst possible nausea)
Measured: postoperatively: at 2 hours, at 8 hours,at 24 hours, at 32 hours, at 48 hours
general wellbeing, NRS 0-10
NRS (numerical rating scale: 0=worst, 10 = best)
Measured: postoperatively: at 2 hours, at 8 hours,at 24 hours, at 32 hours, at 48 hours
quality of sleep, NRS 0-10
NRS (numerical rating scale: 0=worst, 10 = best)
Measured: postoperatively at 24 hours, at 48 hours
time to achieve discharge criteria, hours
time to achieve discharge criteria, hours
Measured: postoperatively: at 24 hours, at 48 hours, at 72 hours, at 96 hours
pain during walking, NRS 0-10
NRS (numerical rating scale: 0=no pain, 10 = worst possible pain)
Measured: preoperatively, postoperatively: at 8 hours, at 48 hours, seventh postoperative day
vomiting, yes/no
vomiting, yes/no
Measured: postoperatively: at 2 hours, at 8 hours,at 24 hours, at 32 hours, at 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Feb 201731 Jan 2018

First posted27 Jan 2017 (estimated)
Study start15 Feb 2017
Primary completion31 Jan 2018
Study completion31 Jan 2018

Why it stopped: Principal investigator (M.K.) left for another workplace. Patient recruitment more difficult than expected.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (16)Papers the sponsor has linked to this study.
Other trials for Arthroplasty, Knee ReplacementStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03034733
Sponsor's protocol ID: Polvitepdexa 24052016
Status last verified: Nov 2018
First submitted: 3 Jan 2017
Last updated: 29 Nov 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 23581549
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.
PubMed 23937923
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.
PubMed 21799397
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.
PubMed 15504179
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.
PubMed 12437261
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.
PubMed 22066560
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.
PubMed 17850557
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.
PubMed 23645340
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.
PubMed 21131371
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.
PubMed 22760385
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.
PubMed 15504180
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.
PubMed 16757774
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.
PubMed 11085349
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.
PubMed 23220857
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.
PubMed 17294992

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Persona SoluTion PPS Femur PMCF
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ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
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RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
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All Arthroplasty, Knee Replacement trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Intravenous Single-dose Dexamethasone on Pain After Total Knee Replacement Surgery
ClinicalTrials.gov ID: NCT03034733
Acronym / sponsor ID: Polvitepdexa 24052016
Conditions: Arthroplasty, Knee Replacement, Pain, Postoperative
Keywords: Arthroplasty, Knee Replacement, Pain, Postoperative, Glucocorticoids, Dexamethasone
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Principal investigator (M.K.) left for another workplace. Patient recruitment more difficult than expected.
Enrolment: 27 participants (actual)
Lead sponsor: University of OuluUniversity, hospital or other
Study start: 15 Feb 2017 (actual)
Primary completion: 31 Jan 2018 (actual)
Study completion: 31 Jan 2018 (actual)
First posted: 27 Jan 2017 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
dexamethasone 0,15 mg/kg	Experimental	Drug: Dexamethasonesingle-dose intravenous dexamethasone 0,15 mg/kg, intraoperative
dexamethasone 0,25 mg/kg	Experimental	Drug: Dexamethasonesingle-dose intravenous dexamethasone 0,25 mg/kg, intraoperative
Sodium Chloride, (24)NaCl 0,9%	Placebo comparator	Drug: Sodium Chloride, (24)NaCl 0,9%single-dose intravenous saline, intraoperative

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DexamethasoneAlso: Oradexonintravenous dexamethasone, two groups: 0,15 mg/kg, 0,25 mg/kg	Drug	dexamethasone 0,15 mg/kg, dexamethasone 0,25 mg/kg
Sodium Chloride, (24)NaCl 0,9%Also: salineintravenous placebo	Drug	Sodium Chloride, (24)NaCl 0,9%

Primary outcome

pain during walking, NRS 0-10
Time frame: at 24 hours postoperatively
NRS (numerical rating scale: 0=no pain, 10 = worst possible pain)

8 secondary outcomes

pain at rest, NRS 0-10
Time frame: 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
Time frame: postoperatively: at 2 hours, at 8 hours, at 24 hours, at 48 hours
nausea, NRS 0-10
Time frame: postoperatively: at 2 hours, at 8 hours,at 24 hours, at 32 hours, at 48 hours
general wellbeing, NRS 0-10
Time frame: postoperatively: at 2 hours, at 8 hours,at 24 hours, at 32 hours, at 48 hours
quality of sleep, NRS 0-10
Time frame: postoperatively at 24 hours, at 48 hours
time to achieve discharge criteria, hours
Time frame: postoperatively: at 24 hours, at 48 hours, at 72 hours, at 96 hours
pain during walking, NRS 0-10
Time frame: preoperatively, postoperatively: at 8 hours, at 48 hours, seventh postoperative day
vomiting, yes/no
Time frame: postoperatively: at 2 hours, at 8 hours,at 24 hours, at 32 hours, at 48 hours

Results and safety

The study was stopped early (reason given: Principal investigator (M.K.) left for another workplace. Patient recruitment more difficult than expected.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
Background: PubMed 23581549Lunn 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.
Background: PubMed 23937923Backes 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.
Background: PubMed 21799397De 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.
Background: PubMed 15504179Gilron 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.
Background: PubMed 12437261Holte 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.
Background: PubMed 22066560Husted 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.
Background: PubMed 17850557Kehlet 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.
Background: PubMed 23645340Koh 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.
Background: PubMed 21131371Lunn 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.
Background: PubMed 22760385Richards 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.
Background: PubMed 15504180Romundstad 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.
Background: PubMed 16757774Salerno 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Matti Kyllönen, MD principal investigator

Oulu University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dexamethasone and Sodium Chloride, (24)NaCl 0,9% in people with Arthroplasty, Knee Replacement and Pain, Postoperative, run by University of Oulu at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pain during walking, NRS 0-10 (time frame: at 24 hours postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03034733, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2018.