Supraclavicular Block vs Retroclavicular Block: Incidence of Phrenic Nerve Paralysis

Sponsor

Brigham and Women's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02631122

Collaborator

(none)

Enrollment

Location

Arms

18.4

Actual Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Phrenic Nerve Paralysis	Procedure: Supraclavicular vs Retroclavicular Nerve Block	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 7, 2017

Actual Primary Completion Date :

Jun 20, 2019

Actual Study Completion Date :

Jun 21, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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