Supraclavicular Versus Combined Block for Ulnar and Median Distribution Hand Surgery
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|ClinicalTrials.gov Identifier: NCT01625208|
Recruitment Status : Unknown
Verified April 2015 by University of Alberta.
Recruitment status was: Active, not recruiting
First Posted : June 21, 2012
Last Update Posted : April 23, 2015
|First Submitted Date ICMJE||June 19, 2012|
|First Posted Date ICMJE||June 21, 2012|
|Last Update Posted Date||April 23, 2015|
|Study Start Date ICMJE||March 2012|
|Actual Primary Completion Date||July 2013 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||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 ]
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.
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT01625208 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Supraclavicular Versus Combined Block for Ulnar and Median Distribution Hand Surgery|
|Official Title ICMJE||Standard Supraclavicular Block Versus Low-Volume Supraclavicular Block Plus Ulnar or Median Nerve Block for Hand Surgery in the Ulnar or Median Nerve Distribution|
|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.|
Regional anesthesia is commonly employed for surgery on the hand. It is well tolerated by most patients and has a high safety record.
The most common form of regional anesthesia for this surgery is the supraclavicular block which is successful in most cases. Occasionally an additional nerve block and/or moderate sedation is required. The most frequent additional nerve blocks required are for the ulnar and median nerves.
This study aims to address whether a low volume supraclavicular block plus a selective ulnar or median nerve block reduces the time taken for onset of anesthesia, reduces the time of post-operative complete limb immobility, improves the surgical success of the block, and increases patient satisfaction, compared to a standard block.
The study will be powered to detect a 25% difference in successful surgical anesthesia.
To ascertain whether the addition of an ulnar or median nerve block to a lower volume supraclavicular block speeds up the onset and consistency of anesthesia, and the return of limb function in patients undergoing hand surgery when compared to a standard supraclavicular block.
Low volume supraclavicular block plus selective distal nerve blocks will speed up the onset of anesthesia, improve surgical anesthetic success and decrease the time to the return of upper limb function when compared to a standard supraclavicular block.
Patients over 18 years of age, listed for hand surgery in the ulnar or median distribution at the University of Alberta Hospital. The study will commence following ethical approval and will run until 160 patients are enrolled.
Consent will be obtained by one of the investigators. Patients not wishing to participate in the study will receive either a brachial plexus block or a general anesthetic as deemed appropriate by the attending anesthesiologist.
Patients to undergo surgery on the ring or pinky fingers will be randomised to receive either a standard supraclavicular block, or a low volume supraclavicular block plus ulnar nerve block. Patients receiving surgery on the thumb, index, or middle fingers will be randomized in a similar fashion to a separate "median" group. All blocks will be placed in a designated block area prior to transfer to the operating room by either an experienced staff anesthesiologist or a supervised fellow in regional anesthesia. The block will be assessed prior to surgery for motor and sensory dysfunction, and the block may be augmented if necessary. The surgeon will determine the effectiveness of the surgical anesthesia, and will indicate a need for surgical local anesthetic top up, heavy sedation or general anesthesia to the anesthesiologist. Sedation can also be administered as per patient request.
Post-operatively, a patient satisfaction questionnaire will be completed. A phone call will be conducted the following day.
Primary outcome measures
1. Successful surgical anesthesia
Secondary outcome measures
Ultrasound-guided supraclavicular blocks have been performed for many years, with a low complication rate. The addition of a peripheral nerve block is not uncommon, and poses minimal additional risk.
Patients will be transferred to the block area. Midazolam will be titrated to an appropriate level. A time out procedure will be undertaken to ensure the correct side is being blocked. The skin will be disinfected. The ultrasound probe will scan the supraclavicular fossa to identify the subclavian artery. The brachial plexus is identified postero-lateral to the artery.
Standard supraclavicular block
The skin will be infiltrated with lidocaine. A needle attached to a nerve stimulator will be introduced. The target will be an area infero-medial to the brachial plexus. In this position 10 - 20 ml of a 3:1 Lidocaine 2%: 0.5% Bupivacaine solution is injected. A more superficial injection is then made. A further 10-20 mls of the Lidocaine:Bupivacaine solution is deposited. The total volume will be recorded with a maximum of 30mls.
Low volume supraclavicular block with ulnar nerve block
The skin infiltration and target of the needle is the same as for the standard supraclavicular block. However, a maximum of 15ml of the solution will be injected. The arm is then abducted and supinated. The ulnar artery is identified. The ulnar nerve is seen medial to the artery. 5ml of the solution is deposited adjacent to the nerve.
Low volume supraclavicular block with median nerve block
The skin infiltration and target of the needle is the same as for the standard supraclavicular block. However, a maximum of 15ml of the solution will be injected. The patient's elbow is flexed and the nerve is visualized on ultrasound in the antecubital fossa lying medial to the brachial artery. Anesthetic solution is deposited in the forearm to target the median nerve.
Following block assessment, the patient will be transferred to the operating theatre. Additional midazolam may be given. Propofol at 50mcg/kg/minute will be commenced if required, and the rate can be increased to 75mcg/kg/minute. If the patient is unable to tolerate the procedure, sedation can be increased to at least 100mcg/kg/minute and the block is deemed an unsuccessful surgical block.
Patients will be assessed for sensory and motor blockade of each nerve at 5 minute intervals.
A successful anesthetic block will be defined as a sensation score in the ulnar or median area of 0 or 1, and an ulnar or median motor score of 2 or less. If this does not occur in the standard group, an ulnar or median nerve block will be performed. If this does not occur in the combined group, a general anesthetic will occur.
Nerve block extent may also be assessed by objective means (e.g., strength testing with a dynamometer).
A successful surgical block will be defined as requiring no further LA top-up or infiltration, and sedation no greater than 75mcg/kg/min.
Data will be collected on a study sheet. Information will be kept confidential and there will be no patient identifiers on the form.
The data collected will be age, sex, height and weight, the type of block used, the amount of local anesthetic used, the length of time taken to perform all blocks, the block assessment data. Intraoperative data will note whether additional local anaesthetic, heavy sedation or general anesthesia was required and the reason. Post-operative data will be a patient questionnaire asking about block-related and surgery-related pain score. A follow up phone call the day after surgery will determine the timing of return of power and sensation of the arm.
|Study Type ICMJE||Interventional|
|Study Phase||Not Applicable|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Estimated Enrollment ICMJE
|Original Estimated Enrollment ICMJE||Same as current|
|Estimated Study Completion Date||December 2015|
|Actual Primary Completion Date||July 2013 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 80 Years (Adult, Older Adult)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Canada|
|Removed Location Countries|
|NCT Number ICMJE||NCT01625208|
|Other Study ID Numbers ICMJE||Pro00027213|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||University of Alberta|
|Study Sponsor ICMJE||University of Alberta|
|Collaborators ICMJE||Not Provided|
|PRS Account||University of Alberta|
|Verification Date||April 2015|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP