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

NCT ID: NCT01898052

Last Updated: 2014-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2014-03-31

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

multimodal drug injection

Intervention Type: DRUG

inject periarticular tissue of the knee

Single anaesthetic drug

Single anaesthetic drug levobupivacaine 150 mg and epinephrine (1:1000) 0.6 ml (0.6 mg)

Group Type: ACTIVE_COMPARATOR

single anaesthetic drug

Intervention Type: DRUG

inject periarticular tissue of the knee after implantation

Interventions

single anaesthetic drug

inject periarticular tissue of the knee after implantation

Intervention Type: DRUG

multimodal drug injection

inject periarticular tissue of the knee

Intervention Type: DRUG

Other Intervention Names

levobupivacaine; chirocaine; anaesthetic cocktail

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thammasat University

OTHER

Sponsor Role: lead

Responsible Party

Supakit Kanitnate

department of orthopeadic surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Supakit Kanitnate, M.D.

Role: PRINCIPAL_INVESTIGATOR

orthopaedics department

Locations

department of orthopaedic surgery, Faculty of medicine, Thammasat university

Khlong Luang, Changwat Pathum Thani, Thailand

Countries

Thailand

Other Identifiers

orthoTU03

Identifier Type: OTHER

Identifier Source: secondary_id

orthoTU03

Identifier Type: -

Identifier Source: org_study_id