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

NCT03542617 | Unknown Phase 4 DMC

• 1 other identifier: ORT-2559-03928
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Visual analogue scales for pain during five-metre walking (0-100)

  Postoperative at 48,72 hours.

• Visual analogue scales for pain on 45 degree active hip flexion (0-100)

  Postoperative at 24,48,72 hours.

• Visual analogue scales for current pain at rest on supine position (0-100)

  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)

  Postoperative at 0-24,24-48,48-72 hours.

• Visual analogue scales for nausea (0-100)

  Postoperative at 6,24,48,72 hours

Study Arms (3)

Normal Saline Solution

PLACEBO COMPARATOR

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

Drug: Normal Saline Solution

10 mg Dexamethasone

ACTIVE COMPARATOR

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

Drug: Dexamethasone

40 mg Dexamethasone

ACTIVE COMPARATOR

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

Drug: Dexamethasone

Interventions

Dexamethasone DRUG

10 mg Dexamethasone; 40 mg Dexamethasone

Normal Saline Solution DRUG

Normal Saline Solution

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chiang Mai University: lead

Study Sites (1)

Department of Orthopedics, Chiang Mai University

Chiang Mai, 50200, Thailand

RECRUITING

MeSH Terms

Conditions

Disease; Osteoarthritis, Hip

Interventions

Dexamethasone; Saline Solution

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Vutinan Manassoontornvuti, MD

CONTACT

+66909712741; m.vutinan@gmail.com

Nitchanant Kitcharanant, MD

CONTACT

+66871071133; nk_win@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Effect of Preoperative Intravenous Dexamethasone on Postoperative Pain After Primary Total Hip Arthroplasty : A prospective, double-blind, randomized controlled trial

Study Record Dates

• First Submitted: May 20, 2018
• First Posted: May 31, 2018
• Study Start: October 5, 2016
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2020
• Last Updated: June 1, 2018

Record last verified: 2018-05

Locations

TH (1)