Single Versus Double Injection Costoclavicular Block

Upper Extremity Injury Clinical Trial

Official title:

A Randomized Comparison Between Single- and Double-injection Ultrasound-Guided Costoclavicular Block

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03595514
• Other study ID #: MUHC 2019-4673
• Status: Recruiting
• Phase: N/A
• Start date: July 30, 2018
• Est. completion date: December 2018

Study information

• Verified date: August 2018
• Source: McGill University Health Center
• Contact: De Q Tran, MD, FRCPC
• Phone: 5149341934
• Email: de_tran[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Arm Injuries
• Upper Extremity Injury

Intervention

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
• 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

Locations

Country	Name	City	State
Canada	Montreal General Hospital	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McGill University Health Center	University of Chile

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Onset time of brachial plexus blockade	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.	Within 30 minutes of block performance
Secondary	Performance time during the brachial plexus block	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)	Intraoperative (During block performance)
Secondary	Number of needle passes	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	Intraoperative (During block performance)
Secondary	Procedure pain during the brachial plexus block	Pain reported during procedure, rated acording to a visual rating scale from 0 to 10 points (0= no pain and 10= worst imaginable pain)	Intraoperative (During block performance)
Secondary	Incidence of surgical anesthesia	Incidence of surgeries performed without the supplemental use of local anesthetics infiltration, narcotics or general anesthesia	Thirty minutes after block performance
Secondary	Incidence of Adverse events	Incidence of adverse events related to brachial plexus block ((paresthesia, vascular puncture, hematoma, Horner syndrome, pneumothorax)	Intraoperative (During block performance)