Supraclavicular Block vs Retroclavicular Block: Incidence of Phrenic Nerve Paralysis

Ultrasound Guided Supraclavicular Brachial Plexus Block vs Retroclavicular Brachial Plexus Block: Comparison of Impact on Ipsilateral Diaphragmatic Function

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.

Study Overview

• Status: Completed
• Conditions: Phrenic Nerve Paralysis
• Intervention / Treatment: Procedure: Supraclavicular vs Retroclavicular Nerve Block

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

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Kamen Vlassakov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Supraclavicular BPNB; Patients in this group will be randomized to receive an Ultrasound Guided Supraclavicular Brachial Plexus Nerve Block and outcomes will be measured over the perioperative and 1day time period.	Procedure: Supraclavicular vs Retroclavicular Nerve Block; An ultrasound-guided supraclavicular or retroclavicular nerve block with 30 ml of 0.5% ropivicaine will be performed on patients scheduled for lower arm surgery; 25 ml to be delivered to the brachial plexus and 5 ml to the intercostal nerve
ACTIVE_COMPARATOR: Retroclavicular BNPB; Patients in this group will be randomized to receive an Ultrasound Guided Retroclavicular Brachial Plexus Nerve Block and outcomes will be measured over the perioperative and 1day time period.	Procedure: Supraclavicular vs Retroclavicular Nerve Block; An ultrasound-guided supraclavicular or retroclavicular nerve block with 30 ml of 0.5% ropivicaine will be performed on patients scheduled for lower arm surgery; 25 ml to be delivered to the brachial plexus and 5 ml to the intercostal nerve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of IIpsilateral Diaphragmatic Paresis	As evidence by ipsilater diagphragmatic excursion measured by Mmode ultrasound	30 minutes post block, then postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anesthetic and analgesic efficacy	Block success will be defined as onset of acceptable sensory and motor blockade	30 minutes post block, then postoperatively
Procedural times (imaging time and needling time), onset time, ease of placement, and block duration	Ultrasonographic block imaging times (time between ultrasound probe placement on the patient and satisfactory image of target anatomy acquisition. needling time (time between needle insertion into the skin and the end of local anesthetic injection through the block needle), onset and duration of sensory block, and proceduralist's rating of ease of block performance will be measured.	at the time of block
Complication rates	Rates of vascular puncture, pneumothorax and paresthesias will be recorded	1 day
Nerve block distribution	measured through sensation (cold and pin prick) over dermatomes of the brachial plexus	30 minutes post block

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Investigators: Principal Investigator: Kamen Vlassakov, MD, kvlassakov@partners.org

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 7, 2017
• Primary Completion (ACTUAL): June 20, 2019
• Study Completion (ACTUAL): June 21, 2019

Study Registration Dates

• First Submitted: December 4, 2015
• First Submitted That Met QC Criteria: December 15, 2015
• First Posted (ESTIMATE): December 16, 2015

Study Record Updates

• Last Update Posted (ACTUAL): October 22, 2019
• Last Update Submitted That Met QC Criteria: October 18, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: nerve block; hemiparesis; regional anesthesia; anesthesiology; Retroclavicular; Supraclavicular; Diagphram
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paralysis
• Other Study ID Numbers: 2015P001537

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No