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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jose Antonio Bernia Gil, Consorci Sanitari de Terrassa
ClinicalTrials.gov Identifier:
NCT01304212
First received: February 24, 2011
Last updated: August 27, 2014
Last verified: August 2014
  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
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

  Eligibility

Ages Eligible for Study:   66 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
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:
Epinephrine
Racepinephrine
Epinephryl borate
Morphine
Ketorolac
Ketorolac Tromethamine
Ropivacaine
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Analgesics
Sensory System Agents

ClinicalTrials.gov processed this record on August 28, 2014