The Efficacy of Periarticular Single Drug Compared With Multimodal Drug Injection in Controlling Pain After TKA

Phase 4

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: single anaesthetic drug; Drug: multimodal drug injection

• Registration Number: NCT01898052
• Lead Sponsor: Thammasat University

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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-07-09
• Study First Submitted QC: 2013-07-11
• Study First Posted: 2013-07-12
• Primary Completion: 2014-02
• Status Verified: 2014-03
• Study Completion: 2014-03
• Last Update Submitted: 2014-03-31
• Last Update Posted: 2014-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single anaesthetic drug	single anaesthetic drug	Single anaesthetic drug levobupivacaine 150 mg and epinephrine (1:1000) 0.6 ml (0.6 mg)
multimodal drug injection	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

Primary Outcome Measures

Name	Time	Method
pain score	48 hour after surgery	pain score at rest and activity between 2 groups every 4 hours until 48 hours after surgery

Secondary Outcome Measures

Name	Time	Method
time to request analgesic drug	48 hours	time when patient request morphine from patient controlled analgesia after intra-operative drug injection

Trial Locations

Locations (1)

department of orthopaedic surgery, Faculty of medicine, Thammasat university; 🇹🇭 Khlong Luang, Pathumthani, Thailand