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

Osteoarthritis, Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03542617
• Other study ID #: ORT-2559-03928
• Status: Recruiting
• Phase: Phase 4
• Start date: October 5, 2016
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2018
• Source: Chiang Mai University
• Contact: Vutinan Manassoontornvuti, MD
• Phone: +66909712741
• Email: m.vutinan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 57
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Localized Primary Osteoarthritis of Both Hips (Diagnosis)
• Osteoarthritis
• Osteoarthritis, Hip
• Pain, Postoperative

Intervention

Drug:
• Dexamethasone

• Normal Saline Solution

Locations

Country	Name	City	State
Thailand	Department of Orthopedics, Chiang Mai University	ChiangMai

Sponsors (1)

Lead Sponsor	Collaborator
Chiang Mai University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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
Secondary	Opioid consumption (mg.)	Opioid consumption (mg.)	Postoperative at 0-24,24-48,48-72 hours
Secondary	Anti-emetic medicine consumption (mg.)	Anti-emetic medicine consumption (mg.)	Postoperative at 0-24,24-48,48-72 hours
Secondary	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.