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WithdrawnNCT01605929Updated Dec 7, 2015

Clinical Evaluation of the Ultrasound-Guided Retroclavicular Brachial Plexus Block

An interventional study of Retroclavicular Brachial Plexus Block and Catheter Insertion in Anesthesia and Upper Extremity Injury, sponsored by Brigham and Women's Hospital. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2015-12-07.

Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Treatment

Why this study was withdrawn
withdrawn before IRB approval
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 100 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Anesthesia
  • Upper Extremity Injury

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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
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In context

Arm Injuries

65 studies on the registry are indexed under Arm Injuries; 11 are open to participants now.

Browse Arm Injuries studies →

Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Retroclavicular Brachial Plexus Block

    Procedure: Retroclavicular Brachial Plexus Block and Catheter Insertion

Interventions

  • ProcedureRetroclavicular 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.

    Also known as: Carbocaine

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What researchers measure

Primary outcomes

  1. 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).

    Time frame: 20 minutes after nerve block completed

Secondary outcomes

  1. Motor Function

    Strength of muscles innervated by radial, median, ulnar, musculocutaneous, and axillary nerves

    Time frame: 20 minutes after nerve block completed

  2. Complication of Procedure

    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

  3. Followup of Block Resolution

    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

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Study locations

1 site
  • Brigham and Women's Hospital
    Boston, Massachusetts 02115, United States
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References and documents

Publications

  • Vlassakov K, Janfaza D. Ultrasound-Guided Retroclavicular Approach to the Brachial Plexus Cords. Abstract, 33rd Annual Regional Anesthesia Meeting and Workshops, 2008.
  • 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.
  • 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. PubMed 17448088 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 7, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01605929
Lead sponsor
Brigham and Women's Hospital
Responsible party
Kamen Vlassakov (Director of the Division of Regional and Orthopedic Anesthesia, Brigham and Women's Hospital) — Principal investigator
First posted
May 25, 2012
Start date
Jul 2012
Primary completion
Sep 2013 (estimated)
Completion
Sep 2013 (estimated)
Last update
Dec 7, 2015

Study contacts

Kamen Vlassakov, MD
principal investigator · Brigham and Women's Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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