Dexamethasone in Pain Control After Total Knee Replacement

• Status: Unknown status
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Hong Kong
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

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