Supraclavicular Versus Combined Block for Ulnar and Median Distribution Hand Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Alberta.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
University of Alberta
ClinicalTrials.gov Identifier:
NCT01625208
First received: June 19, 2012
Last updated: May 15, 2013
Last verified: June 2012
  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

  Show Detailed Description

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

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 October 20, 2014