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Completed

NCT Number: NCT02631122

Supraclavicular Block vs Retroclavicular Block: Incidence of Phrenic Nerve Paralysis

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.

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Key information

Conditions

Phrenic Nerve Paralysis Nervous System Diseases Neurologic Manifestations Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kamen Vlassakov

Boston, Massachusetts, 02115, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients scheduled for lower arm surgery
  • patients aged 18 years or older
  • patients ASA class I-III

Exclusion criteria

  • Patients unable to cooperate or consent to the study
  • pre-existing neuropathy
  • significant pulmonary disease
  • contralateral phrenic nerve or diaphragmatic dysfunction
  • allergy to local anesthetics
  • infection at needle insertion site
  • history of coagulopathy
  • BMI > 40 kg/m2

Treatment and study plan

Supraclavicular vs Retroclavicular Nerve Block

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

Primary outcomes

  1. Incidence of IIpsilateral Diaphragmatic Paresis

    Time frame: 30 minutes post block, then postoperatively

    As evidence by ipsilater diagphragmatic excursion measured by Mmode ultrasound

Secondary outcomes

  1. Anesthetic and analgesic efficacy

    Time frame: 30 minutes post block, then postoperatively

    Block success will be defined as onset of acceptable sensory and motor blockade

  2. Procedural times (imaging time and needling time), onset time, ease of placement, and block duration

    Time frame: at the time of block

    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.

  3. Complication rates

    Time frame: 1 day

    Rates of vascular puncture, pneumothorax and paresthesias will be recorded

  4. Nerve block distribution

    Time frame: 30 minutes post block

    measured through sensation (cold and pin prick) over dermatomes of the brachial plexus

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 16, 2015
Registry last updated
Oct 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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