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

NCT03082092 | Completed Phase 4

• 1 other identifier: PISTKR
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis, Knee

Keywords

Knee; Pain; Recovery; Steroid; Replacement; Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Pain from operated knee using 100mm visual analogue scale

  during walking 5 metres with frame, using 100mm visual analogue scale

  24 hours after surgery

Secondary Outcomes (12)

• Pain from operated knee (other than primary outcome) using 100mm visual analogue scale

  24 hours after surgery

• Pain from operated knee using 100mm visual analogue scale

  30 hours after surgery

• Pain from operated knee using 100mm visual analogue scale

  48 hours after surgery

• Pain from operated knee using 100mm visual analogue scale

  upon discharge usually around post operative day 7

• Range of movement from operated knee

  24, 30, 48 hours after surgery, upon discharge usually around post operative day 7

Study Arms (2)

Methylprednisolone Group

EXPERIMENTAL

The intervention group will receive a single dose intravenous 125mg methylprednisolone diluted in 2.1ml of diluent on induction of total knee replacement.

Drug: Methylprednisolone Sodium Succinate

Placebo Group

PLACEBO COMPARATOR

The placebo group will receive a single dose intravenous 2.1ml of 0.9% IV saline, which is transparent and has no difference in appearance to methylprednisolone, on induction of total knee replacement

Drug: Placebos

Interventions

Methylprednisolone Sodium Succinate DRUG

single intravenous dose of 125mg methylprednisolone diluted in 2.1ml of diluent given on induction of total knee replacement

Methylprednisolone Group

Placebos DRUG

0.9% intravenous saline (2.1ml) intravenously on induction of total knee replacement

Placebo Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective unilateral total knee replacement for primary osteoarthritis of knee
• ASA (American Society of Anesthesiologists) grading 1 or 2

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen Elizabeth Hospital, Hong Kong: lead

Study Sites (1)

Queen Elizabeth Hospital

Hong Kong, Hong Kong

Location

Related Publications (1)

• Cheng BLY, So EHK, Hui GKM, Yung BPK, Tsui ASK, Wang OKF, Poon MWY, Chan ACM, Wong SHS, Li W, Yip PSC. Pre-operative intravenous steroid improves pain and joint mobility after total knee arthroplasty in Chinese population: a double-blind randomized controlled trial. Eur J Orthop Surg Traumatol. 2019 Oct;29(7):1473-1479. doi: 10.1007/s00590-019-02469-5. Epub 2019 Jun 20.

  PMID: 31222540 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain

Interventions

Methylprednisolone Hemisuccinate

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methylprednisolone; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients receiving elective unilateral primary total knee replacement in Queen Elizabeth Hospital during May 2017 to October 2017 will be assessed for eligibility according to the inclusion and exclusion criteria. 50 subjects will be recruited and randomized using computer into intervention group and placebo group by a nurse otherwise not involved in the trial. The randomization will be concealed in an opaque envelope. On the day of operation, a surgeon otherwise not involved in the trial will prepare the methylprednisolone and saline (placebo). The envelope will be opened by the list anesthetist. The operating surgeons, anesthetists, assessors (physiotherapists) and the patients were all blinded to the allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Model Details: single-centre, double-blind, placebo-controlled randomized controlled trial

Study Record Dates

• First Submitted: February 25, 2017
• First Posted: March 17, 2017
• Study Start: June 1, 2017
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: September 4, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)