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Supraclavicular Block vs Retroclavicular Block: Incidence of Phrenic Nerve Paralysis

Primary Purpose

Phrenic Nerve Paralysis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Supraclavicular vs Retroclavicular Nerve Block
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Phrenic Nerve Paralysis focused on measuring Retroclavicular, Supraclavicular, Diagphram, hemiparesis, nerve block, regional anesthesia, anesthesiology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kamen Vlassakov

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Supraclavicular BPNB

Retroclavicular BNPB

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Incidence of IIpsilateral Diaphragmatic Paresis
As evidence by ipsilater diagphragmatic excursion measured by Mmode ultrasound

Secondary Outcome Measures

Anesthetic and analgesic efficacy
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
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
Rates of vascular puncture, pneumothorax and paresthesias will be recorded
Nerve block distribution
measured through sensation (cold and pin prick) over dermatomes of the brachial plexus

Full Information

First Posted
December 4, 2015
Last Updated
October 18, 2019
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02631122
Brief Title
Supraclavicular Block vs Retroclavicular Block: Incidence of Phrenic Nerve Paralysis
Official Title
Ultrasound Guided Supraclavicular Brachial Plexus Block vs Retroclavicular Brachial Plexus Block: Comparison of Impact on Ipsilateral Diaphragmatic Function
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
December 7, 2017 (Actual)
Primary Completion Date
June 20, 2019 (Actual)
Study Completion Date
June 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phrenic Nerve Paralysis
Keywords
Retroclavicular, Supraclavicular, Diagphram, hemiparesis, nerve block, regional anesthesia, anesthesiology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supraclavicular BPNB
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Retroclavicular BNPB
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Supraclavicular vs Retroclavicular Nerve Block
Intervention Description
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 Outcome Measure Information:
Title
Incidence of IIpsilateral Diaphragmatic Paresis
Description
As evidence by ipsilater diagphragmatic excursion measured by Mmode ultrasound
Time Frame
30 minutes post block, then postoperatively
Secondary Outcome Measure Information:
Title
Anesthetic and analgesic efficacy
Description
Block success will be defined as onset of acceptable sensory and motor blockade
Time Frame
30 minutes post block, then postoperatively
Title
Procedural times (imaging time and needling time), onset time, ease of placement, and block duration
Description
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.
Time Frame
at the time of block
Title
Complication rates
Description
Rates of vascular puncture, pneumothorax and paresthesias will be recorded
Time Frame
1 day
Title
Nerve block distribution
Description
measured through sensation (cold and pin prick) over dermatomes of the brachial plexus
Time Frame
30 minutes post block

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kamen Vlassakov, MD
Organizational Affiliation
kvlassakov@partners.org
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kamen Vlassakov
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32925256
Citation
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.
Results Reference
derived

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Supraclavicular Block vs Retroclavicular Block: Incidence of Phrenic Nerve Paralysis

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