Clinical Evaluation of the Ultrasound-Guided Retroclavicular Brachial Plexus Block

Not Applicable

Withdrawn

• Conditions: Upper Extremity Injury; Anesthesia
• Interventions: Procedure: Retroclavicular Brachial Plexus Block and Catheter Insertion

• Registration Number: NCT01605929
• Lead Sponsor: Brigham and Women's Hospital

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.

Study Timeline

• Study First Submitted: 2012-05-16
• Study First Submitted QC: 2012-05-23
• Study First Posted: 2012-05-25
• Study Start: 2012-07
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-04
• Last Update Posted: 2015-12-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Retroclavicular Brachial Plexus Block	Retroclavicular Brachial Plexus Block and Catheter Insertion	-

Primary Outcome Measures

Name	Time	Method
Success Rate	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).

Secondary Outcome Measures

Name	Time	Method
Complication of Procedure	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.
Motor Function	20 minutes after nerve block completed	Strength of muscles innervated by radial, median, ulnar, musculocutaneous, and axillary nerves
Followup of Block Resolution	48-96 hours post Retroclavicular Brachial Plexus Block	Pain/Bruising/Infection at injection site, Unresolved paresthesias/weakness of operative arm, Preferences for Future Surgery

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States