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

March 31, 2014 updated by: Supakit Kanitnate, Thammasat University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Pathumthani
      • Khlong Luang, Pathumthani, Thailand, 12120
        • department of orthopaedic surgery, Faculty of medicine, Thammasat university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: multimodal drug injection
inject periarticular tissue of the knee
Other Names:
  • anaesthetic cocktail
Active Comparator: Single anaesthetic drug
Single anaesthetic drug levobupivacaine 150 mg and epinephrine (1:1000) 0.6 ml (0.6 mg)
Drug: single anaesthetic drug
inject periarticular tissue of the knee after implantation
Other Names:
  • levobupivacaine
  • chirocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
48 hour after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time to request analgesic drug
Time Frame: 48 hours
time when patient request morphine from patient controlled analgesia after intra-operative drug injection
48 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
drug consumption
Time Frame: 48 hours
morphine consumption that record from patient controlled analgesia
48 hours
knee score
Time Frame: 3 months
Knee injury and osteoarthritis outcome score (KOOS) at pre-operation and post-operation 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thammasat University

Investigators

  • Principal Investigator: Supakit Kanitnate, M.D., orthopaedics department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

July 9, 2013

First Submitted That Met QC Criteria

July 11, 2013

First Posted (Estimate)

July 12, 2013

Study Record Updates

Last Update Posted (Estimate)

April 2, 2014

Last Update Submitted That Met QC Criteria

March 31, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • orthoTU03 (Other Identifier: Tha)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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