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Single Versus Double Injection Costoclavicular Block

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03595514
Recruitment Status : Unknown
Verified August 2018 by De Tran, McGill University Health Centre/Research Institute of the McGill University Health Centre.
Recruitment status was:  Recruiting
First Posted : July 23, 2018
Last Update Posted : August 16, 2018
Sponsor:
Collaborator:
University of Chile
Information provided by (Responsible Party):
De Tran, McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief Summary:
In this trial, the objective is to compare single- and double-injection ultrasound-guided costoclavicular blocks. The rationale behind this idea is that a second local anesthetic injection, inside the costoclavicular space, may compensate for the dynamic cord dispersion seen with the single-injection technique. Thus the research hypothesis is that, compared to its single-injection counterpart, a double injection costoclavicular block will result in a shorter onset time.

Condition or disease Intervention/treatment Phase
Upper Extremity Injury Other: Single injection Other: Double injection Drug: lidocaine, bupivacaine, epinephrine, dexamethasone Not Applicable

Detailed Description:

The costoclavicular block (CCB) constitutes a relatively novel technique for infraclavicular brachial plexus blockade, whereby local anesthetics (LAs) are injected inside the costoclavicular space. In this location, the 3 cords of the brachial plexus are very tightly clustered together; this topography would theoretically result in a very swift brachial plexus block Unfortunately, in two recent trials comparing CCB and conventional infraclavicular brachial plexus block, the authors were unable to detect differences in success rate, onset times and LA requirement between the 2 methods. It could be speculated that the explanation resides in dynamic cord dispersion. With CCB, the initial needle target lies in the middle of the 3 cords of the brachial plexus. However, with LA injection, the cords can quickly migrate away from each other. Thus, the anatomical benefits conveyed by the initial compact topography may be lost.

In this trial, the objective is to compare single- and double-injection ultrasound-guided costoclavicular blocks. The rationale behind this idea is that a second local anesthetic injection, inside the costoclavicular space, may compensate for the dynamic cord dispersion seen with the single-injection technique. Thus the research hypothesis is that, compared to its single-injection counterpart, a double injection costoclavicular block will result in a shorter onset time.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Participants will not be allowed to see the ultrasound screen. Outcome assessors will not be present during the performance of the block.
Primary Purpose: Other
Official Title: A Randomized Comparison Between Single- and Double-injection Ultrasound-Guided Costoclavicular Block
Actual Study Start Date : July 30, 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Active Comparator: Single Injection
Local anesthetic injection with a mixture of 35 mL of lidocaine 1.0%-bupivacaine 0.25% with epinephrine 5 µ/mL and dexamethasone 2 mg, in the middle of the three cords of the brachial plexus
Other: Single injection
Local anesthetic injection with a mixture of 35 mL of lidocaine 1.0%-bupivacaine 0.25% with epinephrine 5 µ/mL and dexamethasone 2 mg, in the middle of the three cords of the brachial plexus

Drug: lidocaine, bupivacaine, epinephrine, dexamethasone
lidocaine 1.0%-bupivacaine 0.25% with epinephrine 5 µ/mL and dexamethasone

Experimental: Double Injection
Local anesthetic injection with a mixture of 35 mL of lidocaine 1.0%-bupivacaine 0.25% with epinephrine 5 µ/mL and dexamethasone 2 mg, in the middle of the three cords of the brachial plexus as well as at the intersection of the subclavian artery and the medial cord.
Other: Double injection
Local anesthetic injection with a mixture of 35 mL of lidocaine 1.0%-bupivacaine 0.25% with epinephrine 5 µ/mL and dexamethasone 2 mg, in the middle of the three cords of the brachial plexus as well as at the intersection of the subclavian artery and the medial cord.

Drug: lidocaine, bupivacaine, epinephrine, dexamethasone
lidocaine 1.0%-bupivacaine 0.25% with epinephrine 5 µ/mL and dexamethasone




Primary Outcome Measures :
  1. Onset time of brachial plexus blockade [ Time Frame: Within 30 minutes of block performance ]
    Onset until a minimal composite score of 14 points in a scale of 0-16 points, evaluating sensitive and motor function of each 4 terminal branches.


Secondary Outcome Measures :
  1. Performance time during the brachial plexus block [ Time Frame: Intraoperative (During block performance) ]
    the sum of: 1. the acquisition time of the sonographic image and 2. the time to perform block itself (from skin anesthesia to the end of LA injection)

  2. Number of needle passes [ Time Frame: Intraoperative (During block performance) ]
    The initial needle insertion counted as the first pass. Any subsequent needle advancement that is preceded by a retraction of at least 10 mm counts as an additional pass

  3. Procedure pain during the brachial plexus block [ Time Frame: Intraoperative (During block performance) ]
    Pain reported during procedure, rated acording to a visual rating scale from 0 to 10 points (0= no pain and 10= worst imaginable pain)

  4. Incidence of surgical anesthesia [ Time Frame: Thirty minutes after block performance ]
    Incidence of surgeries performed without the supplemental use of local anesthetics infiltration, narcotics or general anesthesia

  5. Incidence of Adverse events [ Time Frame: Intraoperative (During block performance) ]
    Incidence of adverse events related to brachial plexus block ((paresthesia, vascular puncture, hematoma, Horner syndrome, pneumothorax)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age between 18 and 75 years
  • American Society of Anesthesiologists classification 1-3
  • body mass index between 18 and 30

Exclusion Criteria:

  • adults who are unable to give their own consent
  • pre-existing neuropathy (assessed by history and physical examination)
  • coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or partial thromboplastin time ≥ 50)
  • renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
  • hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
  • allergy to local anesthetic
  • pregnancy
  • prior surgery in the infraclavicular costoclavicular region
  • chronic pain syndromes requiring opioid intake at home

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): NCT03595514


Contacts
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Contact: De Q Tran, MD, FRCPC 5149341934 ext 43261 de_tran@hotmail.com

Locations
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Canada, Quebec
Montreal General Hospital Recruiting
Montreal, Quebec, Canada, H3G-1A4
Contact: De QH Tran, MD, FRCPC    (514)934-1934 ext 43261    de_tran@hotmail.com   
Contact: Roderick J Finlayson, MD, FRCPC    (514)934-1934 ext 43261      
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
University of Chile
Investigators
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Principal Investigator: De Q Tran, MD, FRCPC McGill University Health Centre/Research Institute of the McGill University Health Centre
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: De Tran, Professor, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT03595514    
Other Study ID Numbers: MUHC 2019-4673
First Posted: July 23, 2018    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018
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
Additional relevant MeSH terms:
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Arm Injuries
Wounds and Injuries
Dexamethasone
Lidocaine
Epinephrine
Bupivacaine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents