search
Back to results

Effects of Perioperative Intravenous Dexamethasone on the Severity of Persistent Postsurgical Pain After Total Knee Arthroplasty : A Prospective, Randomized, Double-blind, Placebo-controlled Trial

Primary Purpose

Osteoarthritis of the Knee

Status
Unknown status
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Dexamethasone
Normal saline solution
Sponsored by
Chiang Mai University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age > 40 years (45)
  • Primary knee osteoarthritis diagnosed using the American College of Rheumatology criteria (46)
  • Undergoing elective, primary and unilateral total knee arthroplasty
  • American Society of Anesthesiology (ASA) physical status class 1-3
  • BMI < 40 kg/m2

Exclusion Criteria:

  • History of active rheumatic diseases
  • History of previous musculoskeletal injury of the same knee for excluding patients with secondary knee osteoarthritis
  • History of previous surgery on the same knee
  • History of adverse effects from medications to be used in this study
  • Contraindication to spinal anesthesia
  • History of psychiatric disorders or cognitive impairment
  • Contraindication to corticosteroid agents
  • Poorly controlled diabetes mellitus (HbA1C > 7.5)
  • Poorly controlled hypertension
  • History of ischemic heart disease or peripheral arterial disease or cerebrovascular disease
  • Hepatic insufficiency (Child-Pugh score > 5)
  • Renal insufficiency (Creatinine clearance < 30 mL/min)
  • History of cataracts or glaucoma or ocular hypertension
  • History of steroid or immunosuppressive drug use within 6 months of surgery

Sites / Locations

  • Department of Orthopedics, Chiang Mai UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dexamethasone

Placebo

Arm Description

The steroid group will receive Dexamethasone 10 mg IV immediately prior to induction of spinal anesthesia and will receive a second and third dose of Dexamethasone 10 mg IV postoperatively at 24 and 48 hrs.

The control group will receive sterile normal saline solution, serving as placebo, IV immediately prior to induction of spinal anesthesia and will receive a second and third dose of placebo IV postoperatively 24 and 48 hrs. Both Dexamethasone and normal saline solution will be administered as an IV push.

Outcomes

Primary Outcome Measures

Modified WOMAC scores for pain at 12 weeks postoperative
using the modified Thai version of the Western Ontario and McMaster (WOMAC) osteoarthritis index for knee osteoarthritis questionnaire

Secondary Outcome Measures

Visual analogue scales for pain during a five-meter walk (0-100)
Visual analogue scales for pain during 45 degree active knee flexion (0-100)
Visual analogue scales for current pain at rest in a supine position (0-100)
Visual analogue scales for maximum pain at rest over the last 24 hours and minimum pain at rest over the last 24 hours (0-100)
Visual analogue scale values for nausea (0-100)
Opioid consumption (mg.)
Anti-emetic medicine consumption (mg.)
Maximum degree of active knee flexion
Modified WOMAC scores for pain
using the modified Thai version of the Western Ontario and McMaster (WOMAC) osteoarthritis index for knee osteoarthritis questionnaire
Wound complications

Full Information

First Posted
May 1, 2016
Last Updated
October 7, 2016
Sponsor
Chiang Mai University
search

1. Study Identification

Unique Protocol Identification Number
NCT02760459
Brief Title
Effects of Perioperative Intravenous Dexamethasone on the Severity of Persistent Postsurgical Pain After Total Knee Arthroplasty : A Prospective, Randomized, Double-blind, Placebo-controlled Trial
Official Title
Effects of Perioperative Intravenous Dexamethasone on the Severity of Persistent Postsurgical Pain After Total Knee Arthroplasty : A Prospective, Randomized, Double-blind, Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chiang Mai University

4. Oversight

5. Study Description

Brief Summary
To compare the effects of perioperative intravenous Dexamethasone with a placebo on the severity of persistent postsurgical pain after total knee arthroplasty.
Detailed Description
It is not clear whether perioperative intravenous Dexamethasone has an effect on severity of persistent postsurgical pain (PPSP) after total knee arthroplasty (TKA). The research hypothesis is that TKA patients experience less severe PPSP after administration of perioperative intravenous Dexamethasone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Dexamethasone
Arm Type
Active Comparator
Arm Description
The steroid group will receive Dexamethasone 10 mg IV immediately prior to induction of spinal anesthesia and will receive a second and third dose of Dexamethasone 10 mg IV postoperatively at 24 and 48 hrs.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The control group will receive sterile normal saline solution, serving as placebo, IV immediately prior to induction of spinal anesthesia and will receive a second and third dose of placebo IV postoperatively 24 and 48 hrs. Both Dexamethasone and normal saline solution will be administered as an IV push.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Type
Drug
Intervention Name(s)
Normal saline solution
Primary Outcome Measure Information:
Title
Modified WOMAC scores for pain at 12 weeks postoperative
Description
using the modified Thai version of the Western Ontario and McMaster (WOMAC) osteoarthritis index for knee osteoarthritis questionnaire
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Visual analogue scales for pain during a five-meter walk (0-100)
Time Frame
postoperatively at 24, 30, 48, 54, 72 hrs
Title
Visual analogue scales for pain during 45 degree active knee flexion (0-100)
Time Frame
postoperatively at 6, 24, 30, 48, 54, 72 hrs
Title
Visual analogue scales for current pain at rest in a supine position (0-100)
Time Frame
postoperatively at 6, 24, 30, 48, 54, 72 hrs
Title
Visual analogue scales for maximum pain at rest over the last 24 hours and minimum pain at rest over the last 24 hours (0-100)
Time Frame
postoperatively at 0-24, 24-48, 48-72 hrs
Title
Visual analogue scale values for nausea (0-100)
Time Frame
postoperatively at 6, 24, 30, 48, 54, 72 hrs
Title
Opioid consumption (mg.)
Time Frame
during the first 0-24, 24-48, and 48-72 hrs
Title
Anti-emetic medicine consumption (mg.)
Time Frame
during the first 0-24, 24-48, and 48-72 hrs
Title
Maximum degree of active knee flexion
Time Frame
postoperatively at 24, 48, 72 hrs, 2 weeks, 6 weeks, and 12 weeks
Title
Modified WOMAC scores for pain
Description
using the modified Thai version of the Western Ontario and McMaster (WOMAC) osteoarthritis index for knee osteoarthritis questionnaire
Time Frame
postoperatively at weeks 2 and 6
Title
Wound complications
Time Frame
evaluated postoperatively at weeks 2, 6 and 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 40 years (45) Primary knee osteoarthritis diagnosed using the American College of Rheumatology criteria (46) Undergoing elective, primary and unilateral total knee arthroplasty American Society of Anesthesiology (ASA) physical status class 1-3 BMI < 40 kg/m2 Exclusion Criteria: History of active rheumatic diseases History of previous musculoskeletal injury of the same knee for excluding patients with secondary knee osteoarthritis History of previous surgery on the same knee History of adverse effects from medications to be used in this study Contraindication to spinal anesthesia History of psychiatric disorders or cognitive impairment Contraindication to corticosteroid agents Poorly controlled diabetes mellitus (HbA1C > 7.5) Poorly controlled hypertension History of ischemic heart disease or peripheral arterial disease or cerebrovascular disease Hepatic insufficiency (Child-Pugh score > 5) Renal insufficiency (Creatinine clearance < 30 mL/min) History of cataracts or glaucoma or ocular hypertension History of steroid or immunosuppressive drug use within 6 months of surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nitchanant Kitcharanant, MD
Phone
+66871071133
Email
nk_win@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nitchanant Kitcharanant, MD
Organizational Affiliation
Department of Orthopedics, Faculty of Medicine, Chiang Mai University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Orthopedics, Chiang Mai University
City
ChiangMai
ZIP/Postal Code
50200
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nitchanant Kitchatanant
Phone
+66871071133
Email
nk_win@hotmail.com

12. IPD Sharing Statement

Citations:
Citation
1. Callahan CM, Drake BG, Heck DA, Dittus RS. Patient outcomes following tricompartmental total knee replacement. A meta-analysis. JAMA. 1994;271(17):1349-57. 2. Grosu I, Lavand'homme P, Thienpont E. Pain after knee arthroplasty: an unresolved issue. Knee Surg Sports Traumatol Arthrosc. 2014;22(8):1744-58.
Results Reference
background

Learn more about this trial

Effects of Perioperative Intravenous Dexamethasone on the Severity of Persistent Postsurgical Pain After Total Knee Arthroplasty : A Prospective, Randomized, Double-blind, Placebo-controlled Trial

We'll reach out to this number within 24 hrs