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The Effect of Dexamethasone on Pain After Total Knee Replacement Surgery

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ClinicalTrials.gov Identifier: NCT03034733
Recruitment Status : Terminated (Principal investigator (M.K.) left for another workplace. Patient recruitment more difficult than expected.)
First Posted : January 27, 2017
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
University of Oulu

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.

Condition or disease Intervention/treatment Phase
Arthroplasty, Knee Replacement Pain, Postoperative Drug: Dexamethasone Drug: Sodium Chloride, (24)NaCl 0,9% Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Intravenous Single-dose Dexamethasone on Pain After Total Knee Replacement Surgery
Actual Study Start Date : February 15, 2017
Actual Primary Completion Date : January 31, 2018
Actual Study Completion Date : January 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: dexamethasone 0,15 mg/kg
single-dose intravenous dexamethasone 0,15 mg/kg, intraoperative
Drug: Dexamethasone
intravenous dexamethasone, two groups: 0,15 mg/kg, 0,25 mg/kg
Other Name: Oradexon

Experimental: dexamethasone 0,25 mg/kg
single-dose intravenous dexamethasone 0,25 mg/kg, intraoperative
Drug: Dexamethasone
intravenous dexamethasone, two groups: 0,15 mg/kg, 0,25 mg/kg
Other Name: Oradexon

Placebo Comparator: Sodium Chloride, (24)NaCl 0,9%
single-dose intravenous saline, intraoperative
Drug: Sodium Chloride, (24)NaCl 0,9%
intravenous placebo
Other Name: saline




Primary Outcome Measures :
  1. pain during walking, NRS 0-10 [ Time Frame: at 24 hours postoperatively ]
    NRS (numerical rating scale: 0=no pain, 10 = worst possible pain)


Secondary Outcome Measures :
  1. 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 ]
    NRS (numerical rating scale: 0=no pain, 10 = worst possible pain)

  2. consumption of intravenous oxycodone, milligrams/kilogram body weight [ Time Frame: postoperatively: at 2 hours, at 8 hours, at 24 hours, at 48 hours ]
    cumulative dose of oxycodone administered with a PCA (patient-controlled analgesia)-device

  3. nausea, NRS 0-10 [ Time Frame: postoperatively: at 2 hours, at 8 hours,at 24 hours, at 32 hours, at 48 hours ]
    NRS (numerical rating scale: 0=no nausea, 10 = worst possible nausea)

  4. general wellbeing, NRS 0-10 [ Time Frame: postoperatively: at 2 hours, at 8 hours,at 24 hours, at 32 hours, at 48 hours ]
    NRS (numerical rating scale: 0=worst, 10 = best)

  5. quality of sleep, NRS 0-10 [ Time Frame: postoperatively at 24 hours, at 48 hours ]
    NRS (numerical rating scale: 0=worst, 10 = best)

  6. time to achieve discharge criteria, hours [ Time Frame: postoperatively: at 24 hours, at 48 hours, at 72 hours, at 96 hours ]
    time to achieve discharge criteria, hours

  7. pain during walking, NRS 0-10 [ Time Frame: preoperatively, postoperatively: at 8 hours, at 48 hours, seventh postoperative day ]
    NRS (numerical rating scale: 0=no pain, 10 = worst possible pain)

  8. vomiting, yes/no [ Time Frame: postoperatively: at 2 hours, at 8 hours,at 24 hours, at 32 hours, at 48 hours ]
    vomiting, yes/no


Other Outcome Measures:
  1. blood glucose, mmol/l [ Time Frame: at preoperative visit, at induction of anesthesia, postoperatively: at 2 hours, at 8 hours, at 24 hours, at 32 hours, at 48 hours ]
    blood sample

  2. inflammatory reaction, c-reactive protein (CRP) [ Time Frame: preoperative, postoperatively: at 24 hours, 48 hours ]
    blood sample

  3. wound complication, yes/no [ Time Frame: postoperatively up to 90 days ]
    wound complication, yes/no

  4. wound infection, yes/no [ Time Frame: postoperatively up to 90 days ]
    wound infection, yes/no



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03034733


Locations
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Finland
Oulu University Hospital
Oulu, OYS, Finland, 90029
Sponsors and Collaborators
University of Oulu
Investigators
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Principal Investigator: Matti Kyllönen, MD Oulu University Hospital

Publications:

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Responsible Party: University of Oulu
ClinicalTrials.gov Identifier: NCT03034733     History of Changes
Other Study ID Numbers: Polvitepdexa 24052016
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Oulu:
Arthroplasty
Knee Replacement
Pain, Postoperative
Glucocorticoids
Dexamethasone

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action