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NCT Number: NCT01898052

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

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.

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Key information

Conditions

Postoperative Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

department of orthopaedic surgery, Faculty of medicine, Thammasat university

Khlong Luang, Changwat Pathum Thani, 12120, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

single anaesthetic drug

Drug

inject periarticular tissue of the knee after implantation

Other names: levobupivacaine, chirocaine

multimodal drug injection

Drug

inject periarticular tissue of the knee

Other names: anaesthetic cocktail

Primary outcomes

  1. 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

  1. time to request analgesic drug

    Time frame: 48 hours

    time when patient request morphine from patient controlled analgesia after intra-operative drug injection

Other outcomes

  1. drug consumption

    Time frame: 48 hours

    morphine consumption that record from patient controlled analgesia

  2. knee score

    Time frame: 3 months

    Knee injury and osteoarthritis outcome score (KOOS) at pre-operation and post-operation 3 months

Sponsors and collaborators

Lead sponsor

Thammasat University

Other

Registry information

Official study title

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

Acronym: TKA

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 12, 2013
Registry last updated
Apr 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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