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

Effect of Preoperative Intravenous Dexamethasone on Postoperative Pain After Primary Total Hip Arthroplasty : A Prospective, Double-blind, Randomized Controlled Trial

To compare the effects of preoperative intravenous Dexamethasone between 10 mg and 40 mg with placebo on Postoperative Pain After Primary Total Hip Arthroplasty

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis, Hip; Localized Primary Osteoarthritis of Both Hips (Diagnosis)
• Intervention / Treatment: Drug: Dexamethasone; Drug: Normal Saline Solution

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

• Study Type: Interventional
• Enrollment (Anticipated): 57
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Vutinan Manassoontornvuti, MD; Phone Number: +66909712741; Email: m.vutinan@gmail.com
• Study Contact Backup: Name: Nitchanant Kitcharanant, MD; Phone Number: +66871071133; Email: nk_win@hotmail.com

Study Locations

• Thailand
  • ChiangMai, Thailand, 50200
    • Recruiting
    • Department of Orthopedics, Chiang Mai University
    • Contact: Nitchanant Kitcharanant; Phone Number: +66871071133; Email: nk_win@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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;	at 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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;	Postoperative at 48,72 hours.
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;	Postoperative at 24,48,72 hours.
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;	Postoperative at 6,24,48,72 hours.
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;	Postoperative at 0-24,24-48,48-72 hours.
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	Postoperative at 6,24,48,72 hours
Opioid consumption (mg.)	Opioid consumption (mg.)	Postoperative at 0-24,24-48,48-72 hours
Anti-emetic medicine consumption (mg.)	Anti-emetic medicine consumption (mg.)	Postoperative at 0-24,24-48,48-72 hours
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	Postoperative at Discharge, 2 weeks, 6 weeks, 12 weeks.

Collaborators and Investigators

• Sponsor: Chiang Mai University

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2016
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: May 20, 2018
• First Submitted That Met QC Criteria: May 30, 2018
• First Posted (Actual): May 31, 2018

Study Record Updates

• Last Update Posted (Actual): June 1, 2018
• Last Update Submitted That Met QC Criteria: May 31, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Pain, Postoperative; Osteoarthritis; Osteoarthritis, Hip; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: ORT-2559-03928

Drug and device information, study documents

• 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