Single Versus Double Injection Costoclavicular Block

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

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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)

Eligibility Criteria

• 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

Contacts and Locations

Contacts

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

Locations

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

• Principal Investigator: De Q Tran, MD, FRCPC; McGill University Health Centre/Research Institute of the McGill University Health Centre

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layera S, Aliste J, Bravo D, Fernández D, García A, Finlayson RJ, Tran DQ. Single- versus double-injection costoclavicular block: a randomized comparison. Reg Anesth Pain Med. 2020 Mar;45(3):209-213. doi: 10.1136/rapm-2019-101167. Epub 2020 Jan 14.

• 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
• Last Update Posted: August 16, 2018
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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