Clinical Trial: Clinical Evaluation of the Ultrasound-Guided Retroclavicular Brachial Plexus Block

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Clinical Evaluation of the Ultrasound-Guided Retroclavicular Brachial Plexus Block

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 Summary:

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
Sponsor: Brigham and Women's Hospital

Current Primary Outcome: Success Rate [ Time Frame: 20 minutes after nerve block completed ]

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).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Motor Function [ Time Frame: 20 minutes after nerve block completed ]
    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 ]
    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 ]
    Pain/Bruising/Infection at injection site, Unresolved paresthesias/weakness of operative arm, Preferences for Future Surgery


Original Secondary Outcome: Same as current

Information By: Brigham and Women's Hospital

Dates:
Date Received: May 16, 2012
Date Started: July 2012
Date Completion: September 2013
Last Updated: December 4, 2015
Last Verified: December 2015