Supraclavicular Versus Combined Block for Ulnar and Median Distribution Hand Surgery - Full Text View

Purpose

This study will examine how successfully nerves are blocked or frozen for hand surgery. Traditionally, the nerves are frozen at the base of the neck, just above the clavicle or collarbone (the supraclavicular block). This is mostly successful by itself, and provides anesthesia of the entire arm. Occasionally, an additional nerve block is required further down the arm, as the supraclavicular block may have missed a segment, or it is taking too long to come on. In this study the investigators will compare the traditional technique, with a similar but lower volume supraclavicular block plus an immediate low volume block of one nerve further down the arm (the ulnar or median nerve block, depending on which digits are being operated on). The investigators will compare success rates, speed of onset, procedural comfort and length of time of weakness and numbness, plus any adverse events.

Condition	Intervention
Hand Surgery (Ulnar or Median Distribution) Peripheral Nerve Block	Procedure: Combined nerve block Procedure: Supraclavicular block

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	Standard Supraclavicular Block Versus Low-Volume Supraclavicular Block Plus Ulnar or Median Nerve Block for Hand Surgery in the Ulnar or Median Nerve Distribution

Further study details as provided by University of Alberta:

Primary Outcome Measures:

Successful anesthesia, defined as no additional local anesthetic or heavy sedation required. [ Time Frame: From injection of local anesthetic to suitable nerve blockade for surgery; approximately 20 minutes ] [ Designated as safety issue: No ]
Successful anesthesia will be determined by assessing the nerve block(s) following injection of local anesthetic, and deeming the block sufficient enough for surgery to proceed without any need for additional local anesthetic or heavy sedation. The period between the initial injection and successful anesthesia is approximately 20 minutes, depending on the patient.

Secondary Outcome Measures:

Time to successful anesthetic block from withdrawal of final needle [ Time Frame: Approximately 20 minutes ] [ Designated as safety issue: No ]
The period between final withdrawal of the needle to successful nerve block following assessment will be timed.
Time for procedure, from placement of probe on skin to withdrawal of needle [ Time Frame: Approximately 30 minutes ] [ Designated as safety issue: No ]
The period between initial placement and positioning of the ultrasound probe on the patient to final withdrawal of the needle will be timed.
Duration of analgesia [ Time Frame: Approximately 6 hours ] [ Designated as safety issue: No ]
The length of time between successful nerve block (i.e., when patient is ready for surgery) to the time the anesthesia wears off will be sought.
Duration of motor blockade [ Time Frame: Approximately one hour ] [ Designated as safety issue: No ]
The time taken for the patient to recover motor capability in the area anesthetized following local anesthetic injection will be determined.
Patient satisfaction [ Time Frame: 24-48 hours ] [ Designated as safety issue: No ]
Patient satisfaction with reduction of pain and recovery of motor capability will be assessed in the 24-48 hour period following surgery.

Estimated Enrollment:	160
Study Start Date:	March 2012
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Combined nerve block Participants in this group will receive a supraclavicular brachial plexus block plus a median or ulnar nerve block.	Procedure: Combined nerve block Combined supraclavicular brachial plexus block plus ulnar or median nerve block (depending on the location of surgery)
Active Comparator: Single nerve block Participants in this group will receive a supraclavicular brachial plexus block only.	Procedure: Supraclavicular block Standard supraclavicular brachial plexus block

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Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Over 18 years of age
Surgery on distal upper extremity amenable to a regional anesthetic involving the ulnar (ring, pinky fingers) or median (thumb, index, middle fingers) distribution.

Exclusion Criteria:

Patient refusal
Allergy to amide local anesthetics
Severe coagulopathy
Bilateral upper limb surgery
Surgery involving bone graft from the iliac crest
Request for general anesthetic from surgical or research team (for example, nerve stimulation studies)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01625208

Locations

Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada

Sponsors and Collaborators

University of Alberta

Investigators

Principal Investigator:

James Cameron, MD

University of Alberta

More Information

Publications:

McCartney CJ, Brull R, Chan VW, Katz J, Abbas S, Graham B, Nova H, Rawson R, Anastakis DJ, von Schroeder H. Early but no long-term benefit of regional compared with general anesthesia for ambulatory hand surgery. Anesthesiology. 2004 Aug;101(2):461-7. Erratum in: Anesthesiology. 2004 Oct;101(4):1057.

Perlas A, Lobo G, Lo N, Brull R, Chan VW, Karkhanis R. Ultrasound-guided supraclavicular block: outcome of 510 consecutive cases. Reg Anesth Pain Med. 2009 Mar-Apr;34(2):171-6.

Kapral S, Krafft P, Eibenberger K, Fitzgerald R, Gosch M, Weinstabl C. Ultrasound-guided supraclavicular approach for regional anesthesia of the brachial plexus. Anesth Analg. 1994 Mar;78(3):507-13.

Duggan E, El Beheiry H, Perlas A, Lupu M, Nuica A, Chan VW, Brull R. Minimum effective volume of local anesthetic for ultrasound-guided supraclavicular brachial plexus block. Reg Anesth Pain Med. 2009 May-Jun;34(3):215-8.

Fredrickson MJ, Ting FS, Chinchanwala S, Boland MR. Concomitant infraclavicular plus distal median, radial, and ulnar nerve blockade accelerates upper extremity anaesthesia and improves block consistency compared with infraclavicular block alone. Br J Anaesth. 2011 Aug;107(2):236-42. Epub 2011 May 15.

Hadzic A, Dilberovic F, Shah S, Kulenovic A, Kapur E, Zaciragic A, Cosovic E, Vuckovic I, Divanovic KA, Mornjakovic Z, Thys DM, Santos AC. Combination of intraneural injection and high injection pressure leads to fascicular injury and neurologic deficits in dogs. Reg Anesth Pain Med. 2004 Sep-Oct;29(5):417-23.

Fredrickson MJ, Patel A, Young S, Chinchanwala S. Speed of onset of 'corner pocket supraclavicular' and infraclavicular ultrasound guided brachial plexus block: a randomised observer-blinded comparison. Anaesthesia. 2009 Jul;64(7):738-44.

Responsible Party:	University of Alberta
ClinicalTrials.gov Identifier:	NCT01625208 History of Changes
Other Study ID Numbers:	Pro00027213
Study First Received:	June 19, 2012
Last Updated:	May 15, 2013
Health Authority:	Canada: Ethics Review Committee

ClinicalTrials.gov processed this record on June 18, 2013