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Dexamethasone in Pain Control After Total Knee Replacement
This study is currently recruiting participants.
Verified May 2016 by Dr. Chi-Wai Cheung, The University of Hong Kong
Sponsor:
The University of Hong Kong
Information provided by (Responsible Party):
Dr. Chi-Wai Cheung, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT02767882
First received: May 6, 2016
Last updated: May 20, 2016
Last verified: May 2016
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Purpose
The primary aims of total knee replacement are improvement in functional activities and reduce pain due to degenerated knee joints. However, there are around 20-30% of patients would develop significant pain problem despite uncomplicated total knee replacement. It accounts for major post-operative problems and burdens.
Dexamethasone is glucocorticoid which is associated with anti-inflammatory response. It is well known to have prophylaxis effect for post-operative nausea and vomiting. Perioperative single dose of systemic dexamethasone have shown to be useful for reduction in pain and cumulative opioid consumption. Meta-analysis from De Oliveira et al supports that dexamethasone (up to 0.2 mg/kg) is a safe and effective multimodal pain strategy after surgical procedures. However, this dose recommendation is not surgery specific. It is essential to have more RCTs evaluating the optimal dose of steroid for pain management after hip and knee surgery.
| Condition | Intervention | Phase |
|---|---|---|
| Acute Pain | Drug: Dexamethasone Drug: Saline | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Treatment |
| Official Title: | Effects of Preoperative Dexamethasone in Post-operative Pain Control After Total Knee Replacement |
Resource links provided by NLM:
Further study details as provided by Dr. Chi-Wai Cheung, The University of Hong Kong:
Primary Outcome Measures:
- Pain [ Time Frame: at postoperative day 1 ]Pain will be measured using numerical rating scale
Secondary Outcome Measures:
- quality of recovery [ Time Frame: at postoperative day 1 ]quality of recovery will be measured using Quality of Recovery Questionnaire
| Estimated Enrollment: | 135 |
| Study Start Date: | May 2016 |
| Estimated Study Completion Date: | August 2017 |
| Estimated Primary Completion Date: | May 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Group D1
Patients from group D will be given a bolus injection of 2 ml saline with 2 ml dexamethasone (4mg/ml) before skin incision.
|
Drug: Dexamethasone
Bolus injection of different dose of dexamethasone will be given intravenously prior to incision.
|
|
Experimental: Group D2
4ml bolus injection of dexamethasone (4mg/ml) will be given intravenously prior to incision.
|
Drug: Dexamethasone
Bolus injection of different dose of dexamethasone will be given intravenously prior to incision.
|
|
Placebo Comparator: Group C
4ml bolus injection of 0.9% saline will be given intravenously prior to incision
|
Drug: Saline
Bolus injection of 4ml 0.9% saline will be given intravenously prior to incision.
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- ASA I-III
- Age 18-80 years old
- Scheduled for elective primary unilateral total knee replacement
- Chinese patients
- Able to speak and understand Cantonese
- Able to provide informed oral and written consent
Exclusion Criteria:
- Revision total knee replacement
- Single stage bilateral total knee replacement
- Known allergy to opioids, local anaesthetic drugs, paracetamol, non-steroidal anti-inflammatory drugs (NSAIDS) including COX-2 inhibitors
- History of chronic pain other than chronic knee pain
- History of insulin dependent diabetic mellitus, but not diabetic mellitus on oral hyperglycaemic agents
- History of hepatitis B or C carrier
- History of peptic ulcer
- Hx of tuberculosis
- History of immunosuppression
- Daily use of glucocorticoids
- Daily use of strong opioids (morphine, fentanyl, hydromorphone, ketobemidone, methadone, nicomorphine, oxycodone, or meperidine)
- History of severe heart disease (NYHA 2)
- Alcohol or drug abuse
- Impaired renal function, defined as preoperative serum creatinine level over 120micromol/L
- Pre-existing neurological or muscular disorders
- Psychiatric illness or neurologic or psychiatric diseases potentially influencing pain perception
- Impaired or retarded mental state
- Difficulties in using patient controlled analgesia (PCA)
- Pregnancy
- Local infection
- On immunosuppresants
- Patient refusal
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02767882
Please refer to this study by its ClinicalTrials.gov identifier: NCT02767882
Contacts
| Contact: Chi Wai Cheung, MD, MBBS | 852 22553303 | cheucw@hku.hk |
Locations
| Hong Kong | |
| Queen Mary Hospital | Recruiting |
| Hong Kong, Hong Kong | |
| Contact: Chi Wai Cheung, MD 852-22553303 | |
| Contact: Yvonne Li, BSc 852-22553303 | |
Sponsors and Collaborators
The University of Hong Kong
Investigators
| Principal Investigator: | Chi Wai Cheung, MD, MBBS | The University of Hong Kong |
More Information
| Responsible Party: | Dr. Chi-Wai Cheung, Clinical Associate Professor, The University of Hong Kong |
| ClinicalTrials.gov Identifier: | NCT02767882 History of Changes |
| Other Study ID Numbers: |
UW16-201 |
| Study First Received: | May 6, 2016 |
| Last Updated: | May 20, 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Additional relevant MeSH terms:
|
Acute Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate BB 1101 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 |
ClinicalTrials.gov processed this record on July 17, 2017