Supraclavicular Block vs Retroclavicular Block: Incidence of Phrenic Nerve Paralysis

NCT ID: NCT02631122

Last Updated: 2019-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-07

Study Completion Date

2019-06-21

Brief Summary

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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

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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

Conditions

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Phrenic Nerve Paralysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Supraclavicular vs Retroclavicular Nerve Block

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

Supraclavicular vs Retroclavicular Nerve Block

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kamen Vlassakov

Director of Regional and Orthopedic Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kamen Vlassakov, MD

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Locations

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Kamen Vlassakov

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 32925256 (View on PubMed)

Other Identifiers

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2015P001537

Identifier Type: -

Identifier Source: org_study_id

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