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Multimodal Drug Infiltration in Total Knee Arthroplasty: Is Posterior Capsular Infiltration Worth the Risk?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02860949
Recruitment Status : Completed
First Posted : August 10, 2016
Last Update Posted : October 25, 2016
Sponsor:
Collaborator:
Krit Boontanapibul
Information provided by (Responsible Party):
piya pinsornsak, Thammasat University

Brief Summary:

Multimodal local anesthetic infiltration (LAI) provides effective pain control in patients undergoing total knee arthroplasty (TKA). Some surgeons avoid posterior capsular infiltration (PCI) for fear of damaging posterior neurovascular structures. Data are limited on the added benefits of PCI using different combinations of local anesthetic agents. Therefore, the investigator wanted to know the effectiveness of pain control in LAI with and without PCI.

Half of participants received LAI with PCI, while the other half received LAI without PCI during total knee arthroplasty.


Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: 0.5% bupivacaine 100 mg, morphine sulfate 5 mg, 0.1% epinephrine 0.6 mg, and ketorolac 30 mg mixed NSS up to 100 mL Procedure: Drug injection at Anterior soft tissue (25 mL)+Medial gutter area (25 mL)+Lateral gutter area (25 mL)+Posterior capsular infiltration (25 mL) Procedure: Drug injection at Anterior soft tissue (34 mL)+Medial gutter area (33 mL)+Lateral gutter area (33 mL Phase 2

Detailed Description:
Analgesic agents were bupivacaine, morphine, ketorolac and epinephrine. All patients received spinal anesthesia and patient controlled analgesia (PCA) for 24 hours post surgery. The surgical technique and postoperative medication protocols were identical in both groups. The visual analogue scale (VAS) for pain during activity and at rest, and morphine consumption were recorded at 6, 12, 18 and 24 hours postoperatively. LAI-related side effects, blood loss, length of hospital stay, and VAS for satisfaction were monitored. The reviewer was blinded to treatment groups.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multimodal Drug Infiltration in Total Knee Arthroplasty: Is Posterior Capsular Infiltration Worth the Risk? A Prospective, Double-Blind, Randomized Controlled Trial
Study Start Date : April 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: LAI with PCI
Local anesthetic infiltration with posterior capsular injection (Drug inject at Anterior soft tissue, Medial gutter area, Lateral gutter area and Posterior capsular area)
Drug: 0.5% bupivacaine 100 mg, morphine sulfate 5 mg, 0.1% epinephrine 0.6 mg, and ketorolac 30 mg mixed NSS up to 100 mL
Procedure: Drug injection at Anterior soft tissue (25 mL)+Medial gutter area (25 mL)+Lateral gutter area (25 mL)+Posterior capsular infiltration (25 mL)
Active Comparator: LAI without PCI
Local anesthetic infiltration without posterior capsular injection (Drug inject at Anterior soft tissue, Medial gutter area and Lateral gutter area)
Drug: 0.5% bupivacaine 100 mg, morphine sulfate 5 mg, 0.1% epinephrine 0.6 mg, and ketorolac 30 mg mixed NSS up to 100 mL
Procedure: Drug injection at Anterior soft tissue (34 mL)+Medial gutter area (33 mL)+Lateral gutter area (33 mL



Primary Outcome Measures :
  1. The visual analogue scale (VAS) for pain [ Time Frame: 24 hours after the operation ]

Secondary Outcome Measures :
  1. Morphine consumption from patient controlled analgesia (PCA) [ Time Frame: 24 hours after the operation ]
  2. The visual analogue scale (VAS) for satisfaction [ Time Frame: 24 hours after the operation ]


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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary OA of the knee, aged less than 80 years old, and able to understand and comply with the study procedures.

Exclusion Criteria:

  • Previous drug dependency
  • Inability to undergo a spinal block
  • Allergy to study drugs
  • Renal insufficiency
  • Abnormal liver function
  • History of stroke
  • History of coronary artery disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02860949


Locations
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Thailand
Thammasat university hospital
Pathumthani, Klongluang, Thailand, 12120
Sponsors and Collaborators
Thammasat University
Krit Boontanapibul
Investigators
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Principal Investigator: Piya Pinsornsak, MD Faculty of Medicine, Thammasat university
Publications of Results:

Other Publications:
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Responsible Party: piya pinsornsak, Principal Investigator, Thammasat University
ClinicalTrials.gov Identifier: NCT02860949    
Other Study ID Numbers: MTU-EC-OT-6-130/57
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by piya pinsornsak, Thammasat University:
Local anesthetic infiltration
Posterior capsular infiltration
Multimodal anesthesia
Knee arthroplasty
Pain control
Osteoarthritis, Knee
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Ketorolac
Epinephrine
Morphine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics