Supraclavicular Block vs Retroclavicular Block: Incidence of Phrenic Nerve Paralysis

Phrenic Nerve Paralysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02631122
• Other study ID #: 2015P001537
• Status: Completed
• Phase: N/A
• Start date: December 7, 2017
• Est. completion date: June 21, 2019

Study information

• Verified date: October 2019
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: June 21, 2019
• Est. primary completion date: June 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Paralysis
• Phrenic Nerve Paralysis

Intervention

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

Locations

Country	Name	City	State
United States	Kamen Vlassakov	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of IIpsilateral Diaphragmatic Paresis	As evidence by ipsilater diagphragmatic excursion measured by Mmode ultrasound	30 minutes post block, then postoperatively
Secondary	Anesthetic and analgesic efficacy	Block success will be defined as onset of acceptable sensory and motor blockade	30 minutes post block, then postoperatively
Secondary	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
Secondary	Complication rates	Rates of vascular puncture, pneumothorax and paresthesias will be recorded	1 day
Secondary	Nerve block distribution	measured through sensation (cold and pin prick) over dermatomes of the brachial plexus	30 minutes post block