NCT01605929

Brief Summary

The primary objective of this prospective, descriptive study is to evaluate the success rate of the retroclavicular brachial plexus block and catheter placement in 60 adult patients undergoing hand, wrist, or forearm surgery. The investigators will also evaluate any difficulties performing the procedure, the onset time and distribution of the block, incidence of adverse events, and patient's acceptance of the block.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

Status
withdrawn

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

May 16, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 25, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

December 7, 2015

Status Verified

December 1, 2015

Enrollment Period

1.2 years

First QC Date

May 16, 2012

Last Update Submit

December 4, 2015

Conditions

AnesthesiaUpper Extremity Injury

Keywords

Anesthetics, local/administration & dosageBrachial Plexus/ultrasonographyHumansNerve Block/methodsUpper Extremity/surgeryCatheters, IndwellingAnesthesia, Conduction/methodsAnalgesia/methodsNerve Block/adverse effects

Outcome Measures

Primary Outcomes (1)

  • Success Rate

    Success rate will be defined as the number of patients with anesthesia or analgesia in all five nerves below the elbow (median, ulnar, radial, musculocutaneous, median nerve of the forearm).

    20 minutes after nerve block completed

Secondary Outcomes (3)

  • Motor Function

    20 minutes after nerve block completed

  • Complication of Procedure

    From nerve block completion to patient's arrival in PACU, with an expected average duration of 3 hours

  • Followup of Block Resolution

    48-96 hours post Retroclavicular Brachial Plexus Block

Study Arms (1)

Retroclavicular Brachial Plexus Block

EXPERIMENTAL
Procedure: Retroclavicular Brachial Plexus Block and Catheter Insertion

Interventions

Retroclavicular Brachial Plexus Block and Catheter InsertionPROCEDURE

A Sonosite ultrasound machine will be used to visualize the nerve and needle simultaneously. A Braun 18 g 4 inch Touhy needle with markings will be inserted into the skin and advanced toward the nerve. Once the optimal location is determined under ultrasound visualization, the local anesthetic, mepivacaine, will be injected beside the nerves. The dose of drug will be mepivacaine 1.5%, 0.5 cc/kg (with a minimum 30 cc and maximum of 50 cc.) A Braun 20 g closed tip polyamide catheter will be inserted next to the nerve and left in place to allow for additional medication to be given postoperatively.

Also known as: Carbocaine
Retroclavicular Brachial Plexus Block

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • undergoing surgery of hand, wrist or forearm
  • American Society of Anesthesiologists (ASA) physical status of I-II
  • age greater than 18 years
  • ability to provide written informed consent

You may not qualify if:

  • clinically significant coagulopathy
  • infection at the injection site
  • abnormal anatomy at the block site
  • allergy to amide anesthetics
  • severe pulmonary pathology
  • pre-existing motor or sensory deficits in the operative limb
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (3)

  • Vlassakov K, Janfaza D. Ultrasound-Guided Retroclavicular Approach to the Brachial Plexus Cords. Abstract, 33rd Annual Regional Anesthesia Meeting and Workshops, 2008.

    BACKGROUND

  • Vlassakov K, Brooks M, Islami-Manuchehry A, and Janfaza D. Our First Experience with the Novel Ultrasound-Guided Retroclavicular Block of the Brachial Plexus Cords in Patients with Normal Anatomy, Abstract, 34th Annual Regional Anesthesia Meeting and Workshops, 2009.

    BACKGROUND

  • Hebbard P, Royse C. Ultrasound guided posterior approach to the infraclavicular brachial plexus. Anaesthesia. 2007 May;62(5):539. doi: 10.1111/j.1365-2044.2007.05066.x. No abstract available.

    PMID: 17448088BACKGROUND

MeSH Terms

Conditions

Arm InjuriesAgnosia

Interventions

CatheterizationMepivacaine

Condition Hierarchy (Ancestors)

Wounds and InjuriesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsInvestigative TechniquesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Kamen Vlassakov, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Division of Regional and Orthopedic Anesthesia

Study Record Dates

First Submitted

May 16, 2012

First Posted

May 25, 2012

Study Start

July 1, 2012

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

December 7, 2015

Record last verified: 2015-12

Locations

US(1)