The Effect of Dexamethasone on Pain After Total Knee Replacement Surgery

November 27, 2018 updated by: University of Oulu

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • OYS
      • Oulu, OYS, Finland, 90029
        • Oulu University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Oradexon
PLACEBO_COMPARATOR: Sodium Chloride, (24)NaCl 0,9%
single-dose intravenous saline, intraoperative
Drug: Sodium Chloride, (24)NaCl 0,9%
intravenous placebo
Other Names:
  • saline

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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
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
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)
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
NRS (numerical rating scale: 0=worst, 10 = best)
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
NRS (numerical rating scale: 0=worst, 10 = best)
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
time to achieve discharge criteria, hours
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
NRS (numerical rating scale: 0=no pain, 10 = worst possible pain)
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
vomiting, yes/no
postoperatively: at 2 hours, at 8 hours,at 24 hours, at 32 hours, at 48 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
Time Frame: preoperative, postoperatively: at 24 hours, 48 hours
blood sample
preoperative, postoperatively: at 24 hours, 48 hours
wound complication, yes/no
Time Frame: postoperatively up to 90 days
wound complication, yes/no
postoperatively up to 90 days
wound infection, yes/no
Time Frame: postoperatively up to 90 days
wound infection, yes/no
postoperatively up to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oulu

Investigators

  • Principal Investigator: Matti Kyllönen, MD, Oulu University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 15, 2017

Primary Completion (ACTUAL)

January 31, 2018

Study Completion (ACTUAL)

January 31, 2018

Study Registration Dates

First Submitted

January 3, 2017

First Submitted That Met QC Criteria

January 24, 2017

First Posted (ESTIMATE)

January 27, 2017

Study Record Updates

Last Update Posted (ACTUAL)

November 29, 2018

Last Update Submitted That Met QC Criteria

November 27, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Polvitepdexa 24052016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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