A Comparative Study on the Efficacy of Periarticular Single Anesthetic Drug Compared With Multimodal Drug Injection in Controlling Pain After Total Knee Arthroplasty: A Double Blinded Randomized Controlled Trial
Overview
- Phase
- Phase 4
- Intervention
- multimodal drug injection
- Conditions
- Postoperative Pain
- Sponsor
- Thammasat University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- pain score
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
The purpose of this study is to determine the periarticular multimodal drug injection has more efficacy for controlling pain after TKA than single anaesthetic drug injection.
Detailed Description
Many studies have to determine the efficacy of periarticular multimodal drug injection or single local anaesthetic drug comparing with placebo for pain controlled in TKA. But in this study would like to determine which one of both drugs are more efficacy. In multimodal drug injection consist of levobupivacaine, morphine, ketorolac and epinephrine while single anaesthetic drug has levobupivacaine and epinephrine.
Investigators
Supakit Kanitnate
department of orthopeadic surgery
Thammasat University
Eligibility Criteria
Inclusion Criteria
- •primary osteoarthritis of the knee who undergoing unilateral primary total knee arthroplasty
- •age 50-85 years old
Exclusion Criteria
- •unable to perform spinal anaesthesia
- •history of drug allergies; local anaesthesia, Non-steroidal anti-inflammatory drugs, morphine, epinephrine
- •cognitive function impairment
- •renal impairment (creatinine clearance \< 30 mL/min)
- •liver impairment, gastrointestinal bleeding
Arms & Interventions
multimodal drug injection
Multimodal drug injection Levobupivacaine 150 mg, epinephrine(1:1000) 0.6 mL(0.6 mg), morphine sulfate 5 mL(5 mg), ketorolac 1 mL (30 mg) and mixed with normal saline up to 100 mL
Intervention: multimodal drug injection
Single anaesthetic drug
Single anaesthetic drug levobupivacaine 150 mg and epinephrine (1:1000) 0.6 ml (0.6 mg)
Intervention: single anaesthetic drug
Outcomes
Primary Outcomes
pain score
Time Frame: 48 hour after surgery
pain score at rest and activity between 2 groups every 4 hours until 48 hours after surgery
Secondary Outcomes
- time to request analgesic drug(48 hours)