Clinical trial NCT01605929: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: 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
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2012-05-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Success Rate
timeFrame: 20 minutes after nerve block completed
Secondary outcomes:
measure: Motor Function
timeFrame: 20 minutes after nerve block completed
measure: Complication of Procedure
timeFrame: From nerve block completion to patient's arrival in PACU, with an expected average duration of 3 hours
measure: Followup of Block Resolution
timeFrame: 48-96 hours post Retroclavicular Brachial Plexus Block
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Kamen Vlassakov, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vlassakov K, Janfaza D. Ultrasound-Guided Retroclavicular Approach to the Brachial Plexus Cords. Abstract, 33rd Annual Regional Anesthesia Meeting and Workshops, 2008.
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.
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.