Supraclavicular Block vs Retroclavicular Block: Incidence of Phrenic Nerve Paralysis

Not Applicable

Completed

• Conditions: Phrenic Nerve Paralysis
• Interventions: Procedure: Supraclavicular vs Retroclavicular Nerve Block

• Registration Number: NCT02631122
• Lead Sponsor: Brigham and Women's Hospital

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

Study Timeline

• Study First Submitted: 2015-12-04
• Study First Submitted QC: 2015-12-15
• Study First Posted: 2015-12-16
• Study Start: 2017-12-07
• Primary Completion: 2019-06-20
• Study Completion: 2019-06-21
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-18
• Last Update Posted: 2019-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Retroclavicular BNPB	Supraclavicular vs Retroclavicular Nerve Block	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.
Supraclavicular BPNB	Supraclavicular vs Retroclavicular Nerve Block	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.

Primary Outcome Measures

Name	Time	Method
Incidence of IIpsilateral Diaphragmatic Paresis	30 minutes post block, then postoperatively	As evidence by ipsilater diagphragmatic excursion measured by Mmode ultrasound

Secondary Outcome Measures

Name	Time	Method
Anesthetic and analgesic efficacy	30 minutes post block, then postoperatively	Block success will be defined as onset of acceptable sensory and motor blockade
Procedural times (imaging time and needling time), onset time, ease of placement, and block duration	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.
Complication rates	1 day	Rates of vascular puncture, pneumothorax and paresthesias will be recorded
Nerve block distribution	30 minutes post block	measured through sensation (cold and pin prick) over dermatomes of the brachial plexus

Trial Locations

Locations (1)

Kamen Vlassakov; 🇺🇸 Boston, Massachusetts, United States