Clinical Evaluation of the Ultrasound-Guided Retroclavicular Brachial Plexus Block

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Brigham and Women's Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Kamen Vlassakov, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01605929
First received: May 16, 2012
Last updated: May 23, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Anesthesia
Upper Extremity Injury
Procedure: Retroclavicular Brachial Plexus Block and Catheter Insertion

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the Ultrasound-Guided Retroclavicular Brachial Plexus Block

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Success Rate [ Time Frame: 20 minutes after nerve block completed ] [ Designated as safety issue: No ]
    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 [ Time Frame: 20 minutes after nerve block completed ] [ Designated as safety issue: No ]
    Strength of muscles innervated by radial, median, ulnar, musculocutaneous, and axillary nerves

  • Complication of Procedure [ Time Frame: From nerve block completion to patient's arrival in PACU, with an expected average duration of 3 hours ] [ Designated as safety issue: Yes ]
    Pneumothorax, Horner's syndrome, Symptomatic phrenic nerve palsy, Local anesthesia toxicity, block failure, catheter dislodgement.

  • Followup of Block Resolution [ Time Frame: 48-96 hours post Retroclavicular Brachial Plexus Block ] [ Designated as safety issue: No ]
    Pain/Bruising/Infection at injection site, Unresolved paresthesias/weakness of operative arm, Preferences for Future Surgery


Estimated Enrollment: 60
Study Start Date: July 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Retroclavicular Brachial Plexus Block Procedure: Retroclavicular Brachial Plexus Block and Catheter Insertion
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.
Other Name: Carbocaine

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01605929

Contacts
Contact: Kamen Vlassakov, MD 617-732-8221 kvlassakov@partners.org
Contact: Kathryn A Simms, MD 4165875953 simmska@hotmail.com

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Kamen Vlassakov, MD Brigham and Women's Hospital
  More Information

Publications:
Responsible Party: Kamen Vlassakov, Director of the Division of Regional and Orthopedic Anesthesia, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01605929     History of Changes
Other Study ID Numbers: 2012P000874
Study First Received: May 16, 2012
Last Updated: May 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
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

Additional relevant MeSH terms:
Arm Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on October 29, 2014