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Comparison of the Infraclavicular and Axillary Approaches for Continuous Ultrasound-guided Brachial Plexus Block. (ICAX)

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ClinicalTrials.gov Identifier: NCT04053491
Recruitment Status : Not yet recruiting
First Posted : August 12, 2019
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief Summary:
Prospective randomized study comparing the axillary and the infraclavicular approaches for continuous brachial plexus block after hand surgery.

Condition or disease Intervention/treatment Phase
Anesthesia, Regional Brachial Plexus Block Procedure: Hand surgery under regional anesthesia Not Applicable

Detailed Description:

Regional anesthesia is considered as the gold standard for analgesia and anesthesia of hand surgeries. However, with a single-shot technique, a maximum of 13 hours of analgesia is obtained, even with a long-acting local anesthetic and adjuvants. For painful surgeries necessitating prolonged analgesia of more than 24 hours, continuous regional analgesia techniques have been described, using perinervous catheters. However, these techniques have a high incidence of failure. The most frequent causes of failure are catheter displacements, misplacement, and the distance between the targeted nerves. Many approaches have been described to insert these catheters (axillary, infraclavicular and supraclavicular), but the optimal approach remains unknown. Therefore, international and even local practices vary widely.

Investigators plan to compare the axillary and the infraclavicular approaches in this randomized study, on 60 patients. In every group, an initial bolus will be given and then a perinervous catheter will be inserted by the allocated approach. The surgery will be done under regional anesthesia. The co-analgesia, the local anesthetic infusion and the follow-up will be standardized and will be the same in the two groups.

The primary outcome will be an anesthesia score on 16 points previously described in other similar publication. The primary outcome will be at 24 hours after block realization, but it will be repeated at 48 hours. It will evaluate the degree of sensitive and motor blockade of every major nerve of the hand. Secondary outcomes will be the time, comfort and adverse effects of the technique, and postoperative pain, analgesia, satisfaction and adverse effects.

The aim of this study is to help determine the optimal approach for brachial plexus catheter insertion, in order to improve analgesia, to decrease morphine consumption and its related adverse effects, and to improve patients and caregivers satisfaction.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Comparison of the Infraclavicular and Axillary Approaches for Continuous Ultrasound-guided Brachial Plexus Block: A Prospective Randomized Study
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Arm Intervention/treatment
Experimental: Axillary block group
Initial bolus will be given and then a perinervous catheter will be inserted by the axillary approach.
Procedure: Hand surgery under regional anesthesia
In both groups, patients will benefit from an initial standardized bolus (long-acting local anesthetic, ropivacaine) to cover the operative period, via the allocated approach. Ultrasound guidance and the recommended standards monitors will be used in both groups. After the initial bolus, a catheter will be inserted via the allocated approach. Surgery will be done under regional anesthesia alone, unless there is a medical contraindication or if the patient asks for general anesthesia. Post-operative analgesia will be standardized with regular paracetamol, regular NSAID (Nonsteroidal anti-inflammatory drugs) and oxycodone if needed. The local anesthetics perfusion will be standardized. There will be a medical follow up at 24 and 48 hours where data will be collected.

Experimental: Infraclavicular block group
Initial bolus will be given and then a perinervous catheter will be inserted by the infraclavicular approach.
Procedure: Hand surgery under regional anesthesia
In both groups, patients will benefit from an initial standardized bolus (long-acting local anesthetic, ropivacaine) to cover the operative period, via the allocated approach. Ultrasound guidance and the recommended standards monitors will be used in both groups. After the initial bolus, a catheter will be inserted via the allocated approach. Surgery will be done under regional anesthesia alone, unless there is a medical contraindication or if the patient asks for general anesthesia. Post-operative analgesia will be standardized with regular paracetamol, regular NSAID (Nonsteroidal anti-inflammatory drugs) and oxycodone if needed. The local anesthetics perfusion will be standardized. There will be a medical follow up at 24 and 48 hours where data will be collected.




Primary Outcome Measures :
  1. Anesthesia score [ Time Frame: 24 hours after block realization ]
    Min/Max : 0 for no anesthesia to 16 total anesthesia Addition of Motor block score (0-2) and Sensitive block score (0-2) for the 4 main nerves of the hand


Secondary Outcome Measures :
  1. Duration of catheter insertion procedure [ Time Frame: During block realization ]
  2. Maximal pain during the surgery procedure [ Time Frame: During surgery ]
    Measured by patient with numeric scale from 0 = no pain to 10 = maximal pain

  3. Maximal pain during the first 24 hours [ Time Frame: During the first 24 hours after block realization ]
    Measured by patient with numeric scale from 0 = no pain to 10 = maximal pain

  4. Anesthesia score [ Time Frame: 30 minutes after block realization ]
    Min/Max : 0 for no anesthesia to 16 total anesthesia Addition of Motor block score (0-2) and Sensitive block score (0-2) for the 4 main nerves of the hand

  5. Anesthesia score [ Time Frame: 48 hours after block realization ]
    Min/Max : 0 for no anesthesia to 16 total anesthesia Addition of Motor block score (0-2) and Sensitive block score (0-2) for the 4 main nerves of the hand

  6. Total morphine consumption [ Time Frame: 24 and 48 hours after block realization ]
  7. Mean pain at rest and with movement [ Time Frame: 24 and 48 hours after block realization ]
    Measured by patient with numeric scale from 0 = no pain to 10 = maximal pain

  8. Quality of sleep [ Time Frame: Over first night after block realization ]
    Measured by patient with numeric scale from 0 = insomnia to 10 = excellent sleep

  9. Patient satisfaction [ Time Frame: 48 hours after block realization ]
    Measured by patient with numeric scale from 0 = fully unsatisfied to 10 = fully satisfied



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients with a social insurance number
  • ASA 1-3
  • Patients undergoing hand surgery requiring a continuous brachial plexus block
  • Elective or urgent surgery
  • Effective contraception (HAS criteria)
  • Informed consent

Exclusion Criteria:

  • Contraindication to the installation of a continuous brachial plexus block (coagulopathy, refusal, allergy to the medication)
  • Preexisting neuropathy
  • Pregnancy
  • Arteriovenous fistula
  • Obesity (BMI >40)
  • Another surgical site implicated during the surgery
  • Incapacity to abduct the operated arm
  • Preoperative use of morphine or equivalent

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): NCT04053491


Contacts
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Contact: Karine NOUETTE-GAULAIN, MD-PhD 05 56 79 55 15 ext +33 karine.nouette-gaulain@chu-bordeaux.fr
Contact: Florian ROBIN, MD 05 56 79 55 15 ext +33 florian.robin@chu-bordeaux.fr

Locations
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France
CHU de Bordeaux Not yet recruiting
Bordeaux, France, 33076
Contact: Karine NOUETTE-GAULAIN, MD-PhD    05 56 79 55 15 ext +33    karine.nouette-gaulain@chu-bordeaux.fr   
Contact: Florian ROBIN, MD    05 56 79 55 15 ext +33    florian.robin@chu-bordeaux.fr   
Principal Investigator: Karine NOUETTE-GAULAIN, MD-PhD         
Sub-Investigator: Florian ROBIN, MD         
Sponsors and Collaborators
University Hospital, Bordeaux

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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT04053491     History of Changes
Other Study ID Numbers: CHUBX 2019/04
First Posted: August 12, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Bordeaux:
Hand surgery
Anesthesia, Regional
Brachial Plexus Block
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs