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

This study has been completed.
Information provided by (Responsible Party):
Jose Antonio Bernia Gil, Consorci Sanitari de Terrassa Identifier:
First received: February 24, 2011
Last updated: August 27, 2014
Last verified: August 2014

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
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 Consorci Sanitari de Terrassa:

Primary Outcome Measures:
  • postoperative pain [ Time Frame: 48 hours postoperatively ] [ Designated as safety issue: No ]
    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


Ages Eligible for Study:   66 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01304212

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

No publications provided

Responsible Party: Jose Antonio Bernia Gil, PhD,MD, Consorci Sanitari de Terrassa Identifier: NCT01304212     History of Changes
Other Study ID Numbers: ATR-2011
Study First Received: February 24, 2011
Last Updated: August 27, 2014
Health Authority: SPAIN: Spanish Agency of the drug and medical device

Keywords provided by Consorci Sanitari de Terrassa:
total knee arthroplasty
intraarticular infiltration
femoral block

Additional relevant MeSH terms:
Epinephryl borate
Ketorolac Tromethamine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Analgesics, Non-Narcotic
Analgesics, Opioid
Anesthetics, Local
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Narcotics processed this record on February 27, 2015