Clinical trial NCT02631122: Supraclavicular Block vs Retroclavicular Block: Incidence of Phrenic Nerve Paralysis
Official title: Ultrasound Guided Supraclavicular Brachial Plexus Block vs Retroclavicular Brachial Plexus Block: Comparison of Impact on Ipsilateral Diaphragmatic Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Phrenic Nerve Paralysis
Keywords: Retroclavicular
Supraclavicular
Diagphram
hemiparesis
nerve block
regional anesthesia
anesthesiology
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2015-12-16
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate differences between ultrasound guided supraclavicular versus retroclavicular brachial plexus blocks: two similar brachial plexus nerve block techniques that differ in their needle trajectory and injection site.

Detailed description: To date, there has not been a study that has compared clinically the retroclavicular brachial plexus block to the supraclavicular brachial plexus block or other brachial plexus blocks. The aim of this study is to evaluate differences between ultrasound guided supraclavicular versus retroclavicular brachial plexus blocks, with primary focus on the incidence of diminished ipsilateral hemidiaphramatic excursion (ipsilateral phrenic nerve blockade). We will also evaluate differences between the two techniques in the success of producing surgical anesthesia, procedural time to perform the block (including imaging time and needling time), block onset time, ease of quality ultrasound needle visualization, and incidence of paresthesias, vascular puncture and pneumothorax. Lastly, we will observe and compare the distribution of motor and sensory blockade of the two techniques

Eligibility criteria: Inclusion Criteria:

1. patients scheduled for lower arm surgery
2. patients aged 18 years or older
3. patients ASA class I-III

Exclusion Criteria:

1. Patients unable to cooperate or consent to the study
2. pre-existing neuropathy
3. significant pulmonary disease
4. contralateral phrenic nerve or diaphragmatic dysfunction
5. allergy to local anesthetics
6. infection at needle insertion site
7. history of coagulopathy
8. BMI \> 40 kg/m2

Primary outcomes:
measure: Incidence of IIpsilateral Diaphragmatic Paresis
timeFrame: 30 minutes post block, then postoperatively
Secondary outcomes:
measure: Anesthetic and analgesic efficacy
timeFrame: 30 minutes post block, then postoperatively
measure: Procedural times (imaging time and needling time), onset time, ease of placement, and block duration
timeFrame: at the time of block
measure: Complication rates
timeFrame: 1 day
measure: Nerve block distribution
timeFrame: 30 minutes post block
Other outcomes:
Locations:
city: Boston
country: United States
facility: Kamen Vlassakov
state: Massachusetts
Study officials:
affiliation: kvlassakov@partners.org
name: Kamen Vlassakov, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Georgiadis PL, Vlassakov KV, Patton ME, Lirk PB, Janfaza DR, Zeballos JL, Quaye AN, Patel V, Schreiber KL. Ultrasound-guided supraclavicular vs. retroclavicular block of the brachial plexus: comparison of ipsilateral diaphragmatic function: A randomised clinical trial. Eur J Anaesthesiol. 2021 Jan;38(1):64-72. doi: 10.1097/EJA.0000000000001305.