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The Efficacy of Extra- Versus Intrafascial Injection for Supraclavicular Brachial Plexus Block (SUPRA)

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ClinicalTrials.gov Identifier: NCT03957772
Recruitment Status : Not yet recruiting
First Posted : May 21, 2019
Last Update Posted : May 23, 2019
Sponsor:
Collaborator:
University of Lausanne Hospitals
Information provided by (Responsible Party):
Hôpital du Valais

Brief Summary:

Patients will be randomized to one of two groups:

  1. Extrafascial injection group: Ultrasound-guided supraclavicular brachial plexus block with 2 injections of local anaesthetic, deposited at the exterior of the fascial sheath that surrounds the nerves
  2. Intrafascial injection group: Ultrasound-guided supraclavicular brachial plexus block with 2 injections of local anaesthetic, deposited at the interior of the fascial sheath that surrounds the nerves

Condition or disease Intervention/treatment Phase
Upper Extremity Problem Procedure: Extrafascial injection Procedure: Intrafascial injection Phase 4

Detailed Description:

The study will be proposed to all patients undergoing formarm or hand surgery under axillary brachial plexus block. Patients will be randomized to one of two groups.

The first group - extrafascial injection group - will receive an ultrasound-guided supraclavicular brachial plexus block whereby the local anesthetic will be deposited at the exterior of the fascial sheath that surrounds the nerves.

The second group - intrafascial injection group - will receive an ultrasound-guided supraclavicular brachial plexus block whereby the local anesthetic will be deposited at the interior of the fascial sheath that surrounds the nerves.

All patients will receive the same type and amount of local anesthetic: 30 ml of a mixture of ropivacaine 0.5 % + mepivacaine 1 %.

The primary outcome is the rate of hemidiaphragmatic paresis 30 minutes after the block procedure, assessed with ultrasound. Secondary outcomes are: rate of hemidiaphragmatic paresis 2 hours after surgery, assessed with ultrasound, bedside spirometry before the supraclavicular block, 30 minutes after the block and 2 hours after surgery, rate of successful block 30 minutes after the block , duration of sensory and motor block, pain scores at rest and on movement at 24 h postoperatively, cumulative postoperative opioid consumption at 24 hours postoperatively and patient satisfaction with overall anesthetic management.

These outcomes are further defined in the section below.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel assignment
Masking: Double (Participant, Care Provider)
Masking Description: The participants and all care providers will be blinded to the patient assignment.
Primary Purpose: Treatment
Official Title: The Efficacy of Extra- Versus Intrafascial Injection for Supraclavicular Brachial Plexus Block: a Randomized Controlled, Single-blinded Trial
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : January 31, 2021

Arm Intervention/treatment
Active Comparator: Extrafascial injection

Extrafascial injection of local anesthetic

Ultrasound guided supraclavicular plexus block with extrafascial injection of local anesthetic

Procedure: Extrafascial injection
Extrafascial injection of local anaesthetic under ultrasound guidance

Experimental: Intrafascial injection

Intrafascial injection of local anesthetic

Ultrasound guided supraclavicular plexus block with intrafascial injection of local anesthetic

Procedure: Intrafascial injection
Intrafascial injection of local anaesthetic under ultrasound guidance




Primary Outcome Measures :
  1. Hemidiaphragmatic paresis 30 minutes after the block [ Time Frame: 30 minutes after the block ]
    Rate of hemidiaphragmatic paresis 30 minutes after the block procedure, assessed with ultrasound


Secondary Outcome Measures :
  1. Hemidiaphragmatic paresis 2 hours after surgery [ Time Frame: 2 hours after surgery ]
    Rate of hemidiaphragmatic paresis 2 hours after surgery, assessed with ultrasound

  2. Bedside spirometry before the block (baseline) [ Time Frame: 30 minutes before the block ]
    Bedside spirometry before the supraclavicular block

  3. Bedside spirometry after 30 minutes after the block [ Time Frame: 30 minutes after the supraclavicular block ]
    Bedside spirometry after the supraclavicular block

  4. Bedside spirometry 2 hours after surgery [ Time Frame: 2 hours after surgery ]
    Bedside spirometry 2 hours after surgery

  5. Rate of successful block 30 minutes after the block [ Time Frame: 30 minutes after the block ]
    Presence of a surgical block according to a validated composite scale

  6. Block-related side effects [ Time Frame: 24 h postoperatively ]
    paresthesia, dyspnea, Horner's syndrome, hoarseness, hematoma, infection

  7. Pain during block procedure [ Time Frame: During block procedure ]
    Pain score (numeric rating scale, 0-10, with 0=no pain, 10=worst imaginable pain)

  8. Pain at rest and on movement [ Time Frame: 24 h postoperatively ]
    Pain score (numeric rating scale, 0-10, with 0=no pain, 10=worst imaginable pain)

  9. Postoperative opioid consumption [ Time Frame: 24 hours postoperatively ]
    Cumulative postoperative opioid consumption

  10. Patient satisfaction with overall anesthetic management [ Time Frame: 24 hours postoperatively ]
    numeric rating scale, 0-10)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing forearm or hand surgery under locoregional anesthesia
  • ASA physical status I-III

Exclusion Criteria:

  • Patient refusal
  • ASA physical status IV
  • Severe pre-existing lung disease
  • Patient unwilling or unable to perform incentive spirometry
  • Local anesthetic intolerance or allergy
  • Neurological deficit or neuropathy of the arm
  • Coagulopathy contraindicating locoregional anesthesia
  • Malignancy or infection in the area above the clavicle
  • Pregnancy
  • Inability to understand the informed consent

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): NCT03957772


Contacts
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Contact: Sina Grape, MD 0041276038759 sina.grape@hopitalvs.ch
Contact: Eric Albrecht, MD 0041763281145 eric.albrecht@chuv.ch

Locations
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Switzerland
Hopital du Valais Not yet recruiting
Sion, Switzerland, 1950
Contact: Sina Grape, MD    0041276038756    sina.grape@hopitalvs.ch   
Contact: Eric Albrecht, MD    0041763281145    eric.albrecht@chuv.ch   
Sub-Investigator: Eric Albrecht, MD         
Sponsors and Collaborators
Hôpital du Valais
University of Lausanne Hospitals

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Responsible Party: Hôpital du Valais
ClinicalTrials.gov Identifier: NCT03957772     History of Changes
Other Study ID Numbers: 2019 SUPRA
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no sharing of any IPD

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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 Hôpital du Valais:
upper extremity surgery

Additional relevant MeSH terms:
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Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents