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Trial record 14 of 29 for:    "Collagen Disease" | "Dexamethasone acetate"

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

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ClinicalTrials.gov Identifier: NCT03542617
Recruitment Status : Recruiting
First Posted : May 31, 2018
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
Nitchanant Kitcharanant, Chiang Mai University

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

Condition or disease Intervention/treatment Phase
Localized Primary Osteoarthritis of Both Hips (Diagnosis) Osteoarthritis, Hip Drug: Dexamethasone Drug: Normal Saline Solution Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Preoperative Intravenous Dexamethasone on Postoperative Pain After Primary Total Hip Arthroplasty : A Prospective, Double-blind, Randomized Controlled Trial
Actual Study Start Date : October 5, 2016
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Normal Saline Solution
The control group receive sterile normal saline solution, as placebo, intravenous immediately prior to induction of spinal anesthesia .
Drug: Normal Saline Solution
Active Comparator: 10 mg Dexamethasone
The steroid group will receive Dexamethasone 10 mg IV immediately prior to induction of spinal anesthesia
Drug: Dexamethasone
Active Comparator: 40 mg Dexamethasone
The steroid group will receive Dexamethasone 40 mg IV immediately prior to induction of spinal anesthesia
Drug: Dexamethasone



Primary Outcome Measures :
  1. Visual analogue scales for pain during five-metre walking (0-100) [ Time Frame: at 24 hours postoperatively ]
    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 :
  1. Visual analogue scales for pain during five-metre walking (0-100) [ Time Frame: Postoperative at 48,72 hours. ]
    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;

  2. Visual analogue scales for pain on 45 degree active hip flexion (0-100) [ Time Frame: Postoperative at 24,48,72 hours. ]
    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;

  3. Visual analogue scales for current pain at rest on supine position (0-100) [ Time Frame: Postoperative at 6,24,48,72 hours. ]
    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;

  4. 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) [ Time Frame: Postoperative at 0-24,24-48,48-72 hours. ]
    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;

  5. Visual analogue scales for nausea (0-100) [ Time Frame: Postoperative at 6,24,48,72 hours ]
    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

  6. Opioid consumption (mg.) [ Time Frame: Postoperative at 0-24,24-48,48-72 hours ]
    Opioid consumption (mg.)

  7. Anti-emetic medicine consumption (mg.) [ Time Frame: Postoperative at 0-24,24-48,48-72 hours ]
    Anti-emetic medicine consumption (mg.)

  8. Wound complication [ Time Frame: Postoperative at Discharge, 2 weeks, 6 weeks, 12 weeks. ]
    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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT03542617


Contacts
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Contact: Vutinan Manassoontornvuti, MD +66909712741 m.vutinan@gmail.com
Contact: Nitchanant Kitcharanant, MD +66871071133 nk_win@hotmail.com

Locations
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Thailand
Department of Orthopedics, Chiang Mai University Recruiting
ChiangMai, Thailand, 50200
Contact: Nitchanant Kitcharanant    +66871071133    nk_win@hotmail.com   
Sponsors and Collaborators
Chiang Mai University

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Responsible Party: Nitchanant Kitcharanant, Effect of Preoperative Intravenous Dexamethasone on Postoperative Pain After Primary Total Hip Arthroplasty : A prospective, double-blind, randomized controlled trial, Chiang Mai University
ClinicalTrials.gov Identifier: NCT03542617     History of Changes
Other Study ID Numbers: ORT-2559-03928
First Posted: May 31, 2018    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 2018

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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

Additional relevant MeSH terms:
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Rheumatic Diseases
Dexamethasone
Dexamethasone acetate
BB 1101
Osteoarthritis
Pain, Postoperative
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Pharmaceutical Solutions
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