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Effectiveness of Analgesia in Total Knee Arthroplasty (ATR-2011)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01304212
First Posted: February 25, 2011
Last Update Posted: August 28, 2014
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.
Information provided by (Responsible Party):
Jose Antonio Bernia Gil, Consorci Sanitari de Terrassa
  Purpose
The purpose of this study is to compare the analgesic effectiveness of three techniques: the femoral nerve block, intraarticular infiltration or a combination of both in the control of pain in total knee arthroplasty (KA). The hypothesis to be tested in this study is that the performance multimodal postoperative pain KA combining two analgesic techniques to obtain better analgesia than when applied separately.

Condition Intervention Phase
Pain Drug: several drugs: morphine chloride,ropivacaine,epinephrine,ketorolac Drug: ropivacaine,morphine chloride,epinephrine,ketorolac Drug: ropivacaine Drug: morphine ,ketorolac Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison of the Analgesic Effect of Femoral Nerve Block, Intraarticular Infiltration or a Combination of Both in the Control of Pain in Total Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by Jose Antonio Bernia Gil, Consorci Sanitari de Terrassa:

Primary Outcome Measures:
  • postoperative pain [ Time Frame: 48 hours postoperatively ]
    Is measured at the time of starting rehabilitation, postoperatively 48 hours using visual analog scale, numerical and categorical verbal pain scale at 12,24 and 48 hours


Enrollment: 137
Study Start Date: April 2011
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: femoral block Drug: ropivacaine
The lock is held before starting the operation, viewing with ultrasound and confirmed the femoral nerve with nerve stimulation at an intensity of 0.5 mA and a frequency of 2 Hz Pajunk 50mm needle, patellar flexion. It be administered 30ml of ropivacaine 0.75% (225mg)
Experimental: local infiltration + femoral nerve block
Combination of local infiltration with drugs and femoral nerve block
Drug: morphine ,ketorolac
ultrasound-assisted femoral nerve block is performed and leaks intraoperatively with a 100 ml solution containing: 5 mg of morphine to 0.1% (5ml) +30 mg of ketorolac (1 ml) +96 ml of 0.9% saline.
Active Comparator: several drugs local infiltration Drug: several drugs: morphine chloride,ropivacaine,epinephrine,ketorolac
This technique is performed intraoperatively with a 100 ml solution containing: 225 mg of ropivacaine 1% (22.5 ml) + 5 mg of morphine chloride 0.1% (5ml) + 30 mg of epinephrine 1:1000 (0.3 ml ) + ketorolac 30mg (1ml) +71 ml of 0.9% saline
Drug: ropivacaine,morphine chloride,epinephrine,ketorolac
This technique is performed intraoperatively with a 100 ml solution containing: 225 mg of ropivacaine 1% (22.5 ml) + 5 mg of morphine chloride 0.1% (5ml) + 30 mg of epinephrine 1:1000 (0.3 ml ) + ketorolac 30mg (1ml) +71 ml of 0.9% saline

  Eligibility

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Ages Eligible for Study:   66 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • intervention program for total knee arthroplasty
  • ASA I, II, III
  • over 65 years old

Exclusion Criteria:

  • ASA > III
  • patients who refuse the realization of technical loco-regional anesthesia
  • presence of coagulopathy or impaired hemostatic function
  • BMI > 35
  • Serious intraoperative complications
  • patients undergoing bypass and aortic-femoral or femoro popliteal bypass operated leg
  • patients treated for chronic pain diagnosed processes, different knee osteoarthritis
  Contacts and Locations
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): NCT01304212


Locations
Spain
Consorci Sanitari de Terrassa
Terrassa, Barcelona, Spain, 08227
Sponsors and Collaborators
Jose Antonio Bernia Gil
Investigators
Principal Investigator: José Antonio Bernia Gil, MD, PhD Consorci Sanitari de Terrassa
  More Information

Responsible Party: Jose Antonio Bernia Gil, PhD,MD, Consorci Sanitari de Terrassa
ClinicalTrials.gov Identifier: NCT01304212     History of Changes
Other Study ID Numbers: ATR-2011
First Submitted: February 24, 2011
First Posted: February 25, 2011
Last Update Posted: August 28, 2014
Last Verified: August 2014

Keywords provided by Jose Antonio Bernia Gil, Consorci Sanitari de Terrassa:
total knee arthroplasty
intraarticular infiltration
femoral block

Additional relevant MeSH terms:
Morphine
Ketorolac
Ketorolac Tromethamine
Ropivacaine
Epinephrine
Racepinephrine
Epinephryl borate
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Local
Anesthetics
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
Sympathomimetics
Vasoconstrictor Agents
Anti-Inflammatory Agents, Non-Steroidal