Pre-operative Intravenous Steroid in Total Knee Replacement for Pain Relief and Recovery

• Status: Completed
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Osteoarthritis of the knee is a common and important condition in our society. Despite various anesthetic methods and pain medications, pain after operation still remains as a challenge.

Steroids plays a role in decreasing the inflammatory reaction and stress response from surgery.

This study is to evaluate the use of an additional steroid injection, on top of usual pain killers and anesthesia, on the effect of pain control and recovery after total knee replacement.

50 subjects will be recruited, half of them will be randomized to receive a single dose of steroid injection before operation while the other half will receive a placebo. All the doctors, patients and physiotherapists are not aware of the allocation. Apart from the steroid or placebo injection, all the other treatment (eg: surgery, medications, rehabilitation protocol etc) will be the same. Doctors and physiotherapists will assess the subjects at 24, 30, 48 hours after surgery and upon discharge for their pain relief and recovery. Any complications will also be documented.

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

Details

• Lead Sponsor: Queen Elizabeth Hospital, Hong Kong
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• Elective unilateral total knee replacement for primary osteoarthritis of knee

• ASA (American Society of Anesthesiologists) grading 1 or 2

Exclusion Criteria:

• Rheumatoid arthritis or seronegative arthritis

• Allergy to any medications used in the standard protocol (Methylprednisolone, adrenaline, ropivacaine, ketorolac, bupivacaine, ketorolac, pepcidine, transamin, gabapentin, voltaren, panadol, DF118)

• Chronic opioid use

• Substance dependence

• Patients attending chronic pain clinic

• Psychiatric or neurological condition that may influence pain perception or reporting

• Chronic illness that preclude the use of the medications in the standard protocol

• Hepatitis B carrier or Elevated bilirubin or ALT

• Active peptic ulcer disease

• Uncontrolled diabetic patients with HbA1c >7% in recent 3 months