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Evaluation of Perineural Catheterization Practices in Postoperative Orthopedic Surgery (Cathepos)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04011839
Recruitment Status : Not yet recruiting
First Posted : July 9, 2019
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Brief Summary:

Continuous peripheral nerve blocks are considered as the gold standard for postoperative analgesia in orthopaedic surgery (shoulder, knee, foot). These techniques are also used in chronic pain.

The main disadvantage of these techniques is that they can drive a more or less deep motor block that slows down the rehabilitation process. This disadvantage could be prevented (or minimized) by adapting the protocol for administering local anesthetics or by changing molecules (levobupivacaine 0.625 mg/ml instead of ropivacaine 2 mg/ml). There is no literature comparing the effectiveness of the sensory block and its impact on the motor block according to the administration protocol and/or the type of local anesthetics.

The main judgement criterion of such a study could be a composite criterion crossing the quality of the sensory block and the depth of the motor blockades, the ideal being to have a perfect sensory block without any motor block.


Condition or disease Intervention/treatment
Analgesia Drug: Levobupivacaïne

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Perineural Catheterization Practices in Postoperative Orthopedic Surgery
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Intervention Details:
  • Drug: Levobupivacaïne
    Use of Levobupivacaïne instead ropivacaïne


Primary Outcome Measures :
  1. Comparison between sensory Block Quality and motor Block deep [ Time Frame: Day1 to Day 3 ]
    Composite score between 0 to 2 for Sensory Block and 0 to 2 for motor Block



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients undergoing scheduled orthopedic surgery for which perinervous catheter analgesia is usually indicated (complex shoulder, elbow, femur, knee, foot surgery) will be included.
Criteria

Inclusion Criteria:

  • >18 years old
  • ASA score 1 to 4
  • Scheduled orthopaedic surgery
  • consent to participate

Exclusion Criteria:

  • Pregnant, parturient, or breastfeeding woman
  • Emergency situation
  • Contraindications to local anaesthesia
  • Patient refusal

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): NCT04011839


Contacts
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Contact: Joel L'HERMITE, MD +3346683050 joel.lhermite@chu-nimes.fr

Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT04011839    
Other Study ID Numbers: Local/2018/JL-01
First Posted: July 9, 2019    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Levobupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents