Supraclavicular Versus Combined Block for Ulnar and Median Distribution Hand Surgery

NCT01625208 | Withdrawn

• 1 other identifier: Pro00027213
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hand Surgery (Ulnar or Median Distribution); Peripheral Nerve Block

Outcome Measures

Primary Outcomes (1)

• Successful anesthesia, defined as no additional local anesthetic or heavy sedation required.

  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.

  From injection of local anesthetic to suitable nerve blockade for surgery; approximately 20 minutes

Secondary Outcomes (5)

• Time to successful anesthetic block from withdrawal of final needle

  Approximately 20 minutes

• Time for procedure, from placement of probe on skin to withdrawal of needle

  Approximately 30 minutes

• Duration of analgesia

  Approximately 6 hours

• Duration of motor blockade

  Approximately one hour

• Patient satisfaction

  24-48 hours

Study Arms (2)

Combined nerve block

EXPERIMENTAL

Participants in this group will receive a supraclavicular brachial plexus block plus a median or ulnar nerve block.

Procedure: Combined nerve block

Single nerve block

ACTIVE COMPARATOR

Participants in this group will receive a supraclavicular brachial plexus block only.

Procedure: Supraclavicular block

Interventions

Combined nerve block PROCEDURE

Combined supraclavicular brachial plexus block plus ulnar or median nerve block (depending on the location of surgery)

Combined nerve block

Supraclavicular block PROCEDURE

Standard supraclavicular brachial plexus block

Single nerve block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, Canada

Location

Related Publications (7)

• 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. doi: 10.1097/00000542-200408000-00028.

  PMID: 15277930 BACKGROUND

• 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. doi: 10.1097/AAP.0b013e31819a3f81.

  PMID: 19282715 BACKGROUND

• 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. doi: 10.1213/00000539-199403000-00016.

  PMID: 8109769 BACKGROUND

• 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. doi: 10.1097/AAP.0b013e31819a9542.

  PMID: 19587618 BACKGROUND

• 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. doi: 10.1093/bja/aer101. Epub 2011 May 15.

  PMID: 21576095 BACKGROUND

• 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. doi: 10.1016/j.rapm.2004.06.002.

  PMID: 15372385 BACKGROUND

• 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. doi: 10.1111/j.1365-2044.2009.05918.x.

  PMID: 19624628 BACKGROUND

Study Officials

• James Cameron, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2012
• First Posted: June 21, 2012
• Study Start: March 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 25, 2020

Record last verified: 2015-04

Locations

CA (1)