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The Effect of Dexamethasone on Pain After Total Knee Replacement Surgery

Primary Purpose

Arthroplasty, Knee Replacement, Pain, Postoperative

Status
Terminated
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Dexamethasone
Sodium Chloride, (24)NaCl 0,9%
Sponsored by
University of Oulu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthroplasty, Knee Replacement focused on measuring Arthroplasty, Knee Replacement, Pain, Postoperative, Glucocorticoids, Dexamethasone

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oulu University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

dexamethasone 0,15 mg/kg

dexamethasone 0,25 mg/kg

Sodium Chloride, (24)NaCl 0,9%

Arm Description

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

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

single-dose intravenous saline, intraoperative

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

pain at rest, NRS 0-10
NRS (numerical rating scale: 0=no pain, 10 = worst possible pain)
consumption of intravenous oxycodone, milligrams/kilogram body weight
cumulative dose of oxycodone administered with a PCA (patient-controlled analgesia)-device
nausea, NRS 0-10
NRS (numerical rating scale: 0=no nausea, 10 = worst possible nausea)
general wellbeing, NRS 0-10
NRS (numerical rating scale: 0=worst, 10 = best)
quality of sleep, NRS 0-10
NRS (numerical rating scale: 0=worst, 10 = best)
time to achieve discharge criteria, hours
time to achieve discharge criteria, hours
pain during walking, NRS 0-10
NRS (numerical rating scale: 0=no pain, 10 = worst possible pain)
vomiting, yes/no
vomiting, yes/no

Full Information

First Posted
January 3, 2017
Last Updated
November 27, 2018
Sponsor
University of Oulu
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1. Study Identification

Unique Protocol Identification Number
NCT03034733
Brief Title
The Effect of Dexamethasone on Pain After Total Knee Replacement Surgery
Official Title
The Effect of Intravenous Single-dose Dexamethasone on Pain After Total Knee Replacement Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Terminated
Why Stopped
Principal investigator (M.K.) left for another workplace. Patient recruitment more difficult than expected.
Study Start Date
February 15, 2017 (Actual)
Primary Completion Date
January 31, 2018 (Actual)
Study Completion Date
January 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oulu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthroplasty, Knee Replacement, Pain, Postoperative
Keywords
Arthroplasty, Knee Replacement, Pain, Postoperative, Glucocorticoids, Dexamethasone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dexamethasone 0,15 mg/kg
Arm Type
Experimental
Arm Description
single-dose intravenous dexamethasone 0,15 mg/kg, intraoperative
Arm Title
dexamethasone 0,25 mg/kg
Arm Type
Experimental
Arm Description
single-dose intravenous dexamethasone 0,25 mg/kg, intraoperative
Arm Title
Sodium Chloride, (24)NaCl 0,9%
Arm Type
Placebo Comparator
Arm Description
single-dose intravenous saline, intraoperative
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Oradexon
Intervention Description
intravenous dexamethasone, two groups: 0,15 mg/kg, 0,25 mg/kg
Intervention Type
Drug
Intervention Name(s)
Sodium Chloride, (24)NaCl 0,9%
Other Intervention Name(s)
saline
Intervention Description
intravenous placebo
Primary Outcome Measure Information:
Title
pain during walking, NRS 0-10
Description
NRS (numerical rating scale: 0=no pain, 10 = worst possible pain)
Time Frame
at 24 hours postoperatively
Secondary Outcome Measure Information:
Title
pain at rest, NRS 0-10
Description
NRS (numerical rating scale: 0=no pain, 10 = worst possible pain)
Time Frame
preoperatively, postoperatively: at 2 hours, at 8 hours,at 24 hours, at 32 hours, at 48 hours, seventh postoperative day
Title
consumption of intravenous oxycodone, milligrams/kilogram body weight
Description
cumulative dose of oxycodone administered with a PCA (patient-controlled analgesia)-device
Time Frame
postoperatively: at 2 hours, at 8 hours, at 24 hours, at 48 hours
Title
nausea, NRS 0-10
Description
NRS (numerical rating scale: 0=no nausea, 10 = worst possible nausea)
Time Frame
postoperatively: at 2 hours, at 8 hours,at 24 hours, at 32 hours, at 48 hours
Title
general wellbeing, NRS 0-10
Description
NRS (numerical rating scale: 0=worst, 10 = best)
Time Frame
postoperatively: at 2 hours, at 8 hours,at 24 hours, at 32 hours, at 48 hours
Title
quality of sleep, NRS 0-10
Description
NRS (numerical rating scale: 0=worst, 10 = best)
Time Frame
postoperatively at 24 hours, at 48 hours
Title
time to achieve discharge criteria, hours
Description
time to achieve discharge criteria, hours
Time Frame
postoperatively: at 24 hours, at 48 hours, at 72 hours, at 96 hours
Title
pain during walking, NRS 0-10
Description
NRS (numerical rating scale: 0=no pain, 10 = worst possible pain)
Time Frame
preoperatively, postoperatively: at 8 hours, at 48 hours, seventh postoperative day
Title
vomiting, yes/no
Description
vomiting, yes/no
Time Frame
postoperatively: at 2 hours, at 8 hours,at 24 hours, at 32 hours, at 48 hours
Other Pre-specified Outcome Measures:
Title
blood glucose, mmol/l
Description
blood sample
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
Title
inflammatory reaction, c-reactive protein (CRP)
Description
blood sample
Time Frame
preoperative, postoperatively: at 24 hours, 48 hours
Title
wound complication, yes/no
Description
wound complication, yes/no
Time Frame
postoperatively up to 90 days
Title
wound infection, yes/no
Description
wound infection, yes/no
Time Frame
postoperatively up to 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matti Kyllönen, MD
Organizational Affiliation
Oulu University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oulu University Hospital
City
Oulu
State/Province
OYS
ZIP/Postal Code
90029
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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The Effect of Dexamethasone on Pain After Total Knee Replacement Surgery

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