NCT02631122

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 16, 2015

Completed
2 years until next milestone

Study Start

First participant enrolled

December 7, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2019

Completed
Last Updated

October 22, 2019

Status Verified

October 1, 2019

Enrollment Period

1.5 years

First QC Date

December 4, 2015

Last Update Submit

October 18, 2019

Conditions

Phrenic Nerve Paralysis

Keywords

RetroclavicularSupraclavicularDiagphramhemiparesisnerve blockregional anesthesiaanesthesiology

Outcome Measures

Primary Outcomes (1)

  • Incidence of IIpsilateral Diaphragmatic Paresis

    As evidence by ipsilater diagphragmatic excursion measured by Mmode ultrasound

    30 minutes post block, then postoperatively

Secondary Outcomes (4)

  • Anesthetic and analgesic efficacy

    30 minutes post block, then postoperatively

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

    at the time of block

  • Complication rates

    1 day

  • Nerve block distribution

    30 minutes post block

Study Arms (2)

Supraclavicular BPNB

ACTIVE COMPARATOR

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

Retroclavicular BNPB

ACTIVE COMPARATOR

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

Interventions

Supraclavicular vs Retroclavicular Nerve BlockPROCEDURE

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

Retroclavicular BNPBSupraclavicular BPNB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kamen Vlassakov

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • 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.

    PMID: 32925256DERIVED

MeSH Terms

Conditions

Paresis

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kamen Vlassakov, MD

    kvlassakov@partners.org

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Regional and Orthopedic Anesthesiology

Study Record Dates

First Submitted

December 4, 2015

First Posted

December 16, 2015

Study Start

December 7, 2017

Primary Completion

June 20, 2019

Study Completion

June 21, 2019

Last Updated

October 22, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)