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Effect of Preoperative Intravenous Dexamethasone on Postoperative Pain After Primary Total Hip Arthroplasty

Primary Purpose

Localized Primary Osteoarthritis of Both Hips (Diagnosis), Osteoarthritis, Hip

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 Localized Primary Osteoarthritis of Both Hips (Diagnosis)

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age > 18 years
  • Undergoing Elective, Primary, unilateral Total Hip arthroplasty
  • American Society of Anesthesiology (ASA) physical class 1-3
  • BMI < 40 kg/m2

Exclusion Criteria:

  • History of previous musculoskeletal injury on the same hip
  • History of prior surgery on the same unilateral hip
  • History of adverse effects from medication utilized in this study
  • Contraindication to spinal anesthesia
  • History of psychiatric disorders or cognitive impairment
  • Contraindication to Corticosteroid
  • Poorly controlled Diabetes mellitus
  • 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 cataract or glaucoma or ocular hypertension

Sites / Locations

  • Department of Orthopedics, Chiang Mai UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Normal Saline Solution

10 mg Dexamethasone

40 mg Dexamethasone

Arm Description

The control group receive sterile normal saline solution, as placebo, intravenous immediately prior to induction of spinal anesthesia .

The steroid group will receive Dexamethasone 10 mg IV immediately prior to induction of spinal anesthesia

The steroid group will receive Dexamethasone 40 mg IV immediately prior to induction of spinal anesthesia

Outcomes

Primary Outcome Measures

Visual analogue scales for pain during five-metre walking (0-100)
Each pain outcome will be assessed using a visual analogue scale of 0-100 mm, in which 0 indicates no pain and 100 indicates the worst pain;

Secondary Outcome Measures

Visual analogue scales for pain during five-metre walking (0-100)
Each pain outcome will be assessed using a visual analogue scale of 0-100 mm, in which 0 indicates no pain and 100 indicates the worst pain;
Visual analogue scales for pain on 45 degree active hip flexion (0-100)
Each pain outcome will be assessed using a visual analogue scale of 0-100 mm, in which 0 indicates no pain and 100 indicates the worst pain;
Visual analogue scales for current pain at rest on supine position (0-100)
Each pain outcome will be assessed using a visual analogue scale of 0-100 mm, in which 0 indicates no pain and 100 indicates the worst pain;
Visual analogue scales for the maximal pain at rest over the last 24 hours and the minimal pain at rest over the last 24 hours (0-100)
Each pain outcome will be assessed using a visual analogue scale of 0-100 mm, in which 0 indicates no pain and 100 indicates the worst pain;
Visual analogue scales for nausea (0-100)
This outcome will be assessed in a form of visual analogue scale of 0-100 mm, in which 0 indicates no nausea or vomiting and 100 indicates the worst nausea or vomiting
Opioid consumption (mg.)
Opioid consumption (mg.)
Anti-emetic medicine consumption (mg.)
Anti-emetic medicine consumption (mg.)
Wound complication
Wound complications (including periprosthetic joint infection and inadequate wound healing). Periprosthetic joint infection will be diagnosed using the criteria outlined by the Musculoskeletal Infection Society. Inadequate wound healing is defined as delayed wound healing or wound dehiscence

Full Information

First Posted
May 20, 2018
Last Updated
May 31, 2018
Sponsor
Chiang Mai University
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1. Study Identification

Unique Protocol Identification Number
NCT03542617
Brief Title
Effect of Preoperative Intravenous Dexamethasone on Postoperative Pain After Primary Total Hip Arthroplasty
Official Title
Effect of Preoperative Intravenous Dexamethasone on Postoperative Pain After Primary Total Hip Arthroplasty : A Prospective, Double-blind, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 5, 2016 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To compare the effects of preoperative intravenous Dexamethasone between 10 mg and 40 mg with placebo on Postoperative Pain After Primary Total Hip Arthroplasty
Detailed Description
It still unclear whether the effective dose preoperative intravenous dexamethasone on postoperative pain after Total Hip Arthroplasty. The research hypothesis is that the effect of 10 mg intravenous Dexamethasone in postoperative pain(5 metre walking at 24 hour) is not inferior to 40 mg intravenous Dexamethasone

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Localized Primary Osteoarthritis of Both Hips (Diagnosis), Osteoarthritis, Hip

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Normal Saline Solution
Arm Type
Placebo Comparator
Arm Description
The control group receive sterile normal saline solution, as placebo, intravenous immediately prior to induction of spinal anesthesia .
Arm Title
10 mg Dexamethasone
Arm Type
Active Comparator
Arm Description
The steroid group will receive Dexamethasone 10 mg IV immediately prior to induction of spinal anesthesia
Arm Title
40 mg Dexamethasone
Arm Type
Active Comparator
Arm Description
The steroid group will receive Dexamethasone 40 mg IV immediately prior to induction of spinal anesthesia
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Type
Drug
Intervention Name(s)
Normal Saline Solution
Primary Outcome Measure Information:
Title
Visual analogue scales for pain during five-metre walking (0-100)
Description
Each pain outcome will be assessed using a visual analogue scale of 0-100 mm, in which 0 indicates no pain and 100 indicates the worst pain;
Time Frame
at 24 hours postoperatively
Secondary Outcome Measure Information:
Title
Visual analogue scales for pain during five-metre walking (0-100)
Description
Each pain outcome will be assessed using a visual analogue scale of 0-100 mm, in which 0 indicates no pain and 100 indicates the worst pain;
Time Frame
Postoperative at 48,72 hours.
Title
Visual analogue scales for pain on 45 degree active hip flexion (0-100)
Description
Each pain outcome will be assessed using a visual analogue scale of 0-100 mm, in which 0 indicates no pain and 100 indicates the worst pain;
Time Frame
Postoperative at 24,48,72 hours.
Title
Visual analogue scales for current pain at rest on supine position (0-100)
Description
Each pain outcome will be assessed using a visual analogue scale of 0-100 mm, in which 0 indicates no pain and 100 indicates the worst pain;
Time Frame
Postoperative at 6,24,48,72 hours.
Title
Visual analogue scales for the maximal pain at rest over the last 24 hours and the minimal pain at rest over the last 24 hours (0-100)
Description
Each pain outcome will be assessed using a visual analogue scale of 0-100 mm, in which 0 indicates no pain and 100 indicates the worst pain;
Time Frame
Postoperative at 0-24,24-48,48-72 hours.
Title
Visual analogue scales for nausea (0-100)
Description
This outcome will be assessed in a form of visual analogue scale of 0-100 mm, in which 0 indicates no nausea or vomiting and 100 indicates the worst nausea or vomiting
Time Frame
Postoperative at 6,24,48,72 hours
Title
Opioid consumption (mg.)
Description
Opioid consumption (mg.)
Time Frame
Postoperative at 0-24,24-48,48-72 hours
Title
Anti-emetic medicine consumption (mg.)
Description
Anti-emetic medicine consumption (mg.)
Time Frame
Postoperative at 0-24,24-48,48-72 hours
Title
Wound complication
Description
Wound complications (including periprosthetic joint infection and inadequate wound healing). Periprosthetic joint infection will be diagnosed using the criteria outlined by the Musculoskeletal Infection Society. Inadequate wound healing is defined as delayed wound healing or wound dehiscence
Time Frame
Postoperative at Discharge, 2 weeks, 6 weeks, 12 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age > 18 years Undergoing Elective, Primary, unilateral Total Hip arthroplasty American Society of Anesthesiology (ASA) physical class 1-3 BMI < 40 kg/m2 Exclusion Criteria: History of previous musculoskeletal injury on the same hip History of prior surgery on the same unilateral hip History of adverse effects from medication utilized in this study Contraindication to spinal anesthesia History of psychiatric disorders or cognitive impairment Contraindication to Corticosteroid Poorly controlled Diabetes mellitus 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 cataract or glaucoma or ocular hypertension
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vutinan Manassoontornvuti, MD
Phone
+66909712741
Email
m.vutinan@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nitchanant Kitcharanant, MD
Phone
+66871071133
Email
nk_win@hotmail.com
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 Kitcharanant
Phone
+66871071133
Email
nk_win@hotmail.com

12. IPD Sharing Statement

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Effect of Preoperative Intravenous Dexamethasone on Postoperative Pain After Primary Total Hip Arthroplasty

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