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Clinical Evaluation of the Ultrasound-Guided Retroclavicular Brachial Plexus Block

Primary Purpose

Anesthesia, Upper Extremity Injury

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Retroclavicular Brachial Plexus Block and Catheter Insertion
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthesia focused on measuring Anesthetics, local/administration & dosage, Brachial Plexus/ultrasonography, Humans, Nerve Block/methods, Upper Extremity/surgery, Catheters, Indwelling, Anesthesia, Conduction/methods, Analgesia/methods, Nerve Block/adverse effects

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Retroclavicular Brachial Plexus Block

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Motor Function
Strength of muscles innervated by radial, median, ulnar, musculocutaneous, and axillary nerves
Complication of Procedure
Pneumothorax, Horner's syndrome, Symptomatic phrenic nerve palsy, Local anesthesia toxicity, block failure, catheter dislodgement.
Followup of Block Resolution
Pain/Bruising/Infection at injection site, Unresolved paresthesias/weakness of operative arm, Preferences for Future Surgery

Full Information

First Posted
May 16, 2012
Last Updated
December 4, 2015
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01605929
Brief Title
Clinical Evaluation of the Ultrasound-Guided Retroclavicular Brachial Plexus Block
Official Title
Clinical Evaluation of the Ultrasound-Guided Retroclavicular Brachial Plexus Block
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Withdrawn
Why Stopped
withdrawn before IRB approval
Study Start Date
July 2012 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
September 2013 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Nerve blocks are used by anesthesiologists as methods of pain control or to allow for painless surgery on a limb, rendering a general anesthetic for surgery unnecessary. Local anesthetic medication is injected through a needle next to a nerve, often using an ultrasound machine to visualize both the needle and nerve simultaneously. A catheter, a small plastic tube, can be inserted next to the nerve in order to provide pain relief for hours or days after surgery. The nerves that provide sensation to the forearm, wrist and hand are the radial, median, ulnar, musculocutaneous and medial nerve of the forearm. These nerves originate from a network of nerve fibers that exit the spinal cord at the level of the neck. They are tightly bundled together, forming the brachial plexus, from the neck to just above the axilla, providing the anesthesiologist with many locations to perform a nerve block. One such block, known as the infraclavicular block, approaches the nerves just beneath the clavicle and has been performed for decades. This study aims to examine a new technique to block the brachial plexus, performed at a similar level as the infraclavicular brachial plexus nerve block. The ultrasound-guided retroclavicular brachial plexus block has the potential advantages of being easier to perform, more successful, less painful for the patient, and a better pathway for catheter placement. It differs from the infraclavicular nerve block in that the needle is inserted above the clavicle rather than below it. In addition, it will allow the anesthesiologist to have another approach to the brachial plexus, which can be utilized if patients cannot have an infraclavicular block or any other brachial plexus block due to anatomical changes, or infection at the sight. The retroclavicular brachial plexus block was first used in two patients at Brigham and Women's Hospital in whom the infraclavicular approach was contraindicated due to anatomical changes after surgery or trauma. This procedure has been found to be a reliable way to perform a brachial plexus nerve block and has become a routine procedure at Brigham and Women's Hospital for hand or forearm surgery over the past three years. In reviewing the literature, a similar procedure was introduced by Hebbard and Royse in 2007, but no patient data was reported. By assessing the procedure in a prospective study, the investigators will be able to describe the technique, the success rate and any complications in the literature to allow other anesthesiologists to potentially incorporate this block into their repertoire.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Upper Extremity Injury
Keywords
Anesthetics, local/administration & dosage, Brachial Plexus/ultrasonography, Humans, Nerve Block/methods, Upper Extremity/surgery, Catheters, Indwelling, Anesthesia, Conduction/methods, Analgesia/methods, Nerve Block/adverse effects

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Retroclavicular Brachial Plexus Block
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Retroclavicular Brachial Plexus Block and Catheter Insertion
Other Intervention Name(s)
Carbocaine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Success Rate
Description
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).
Time Frame
20 minutes after nerve block completed
Secondary Outcome Measure Information:
Title
Motor Function
Description
Strength of muscles innervated by radial, median, ulnar, musculocutaneous, and axillary nerves
Time Frame
20 minutes after nerve block completed
Title
Complication of Procedure
Description
Pneumothorax, Horner's syndrome, Symptomatic phrenic nerve palsy, Local anesthesia toxicity, block failure, catheter dislodgement.
Time Frame
From nerve block completion to patient's arrival in PACU, with an expected average duration of 3 hours
Title
Followup of Block Resolution
Description
Pain/Bruising/Infection at injection site, Unresolved paresthesias/weakness of operative arm, Preferences for Future Surgery
Time Frame
48-96 hours post Retroclavicular Brachial Plexus Block

10. Eligibility

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

12. IPD Sharing Statement

Citations:
Citation
Vlassakov K, Janfaza D. Ultrasound-Guided Retroclavicular Approach to the Brachial Plexus Cords. Abstract, 33rd Annual Regional Anesthesia Meeting and Workshops, 2008.
Results Reference
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Citation
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.
Results Reference
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PubMed Identifier
17448088
Citation
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.
Results Reference
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Clinical Evaluation of the Ultrasound-Guided Retroclavicular Brachial Plexus Block

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