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Hand Surgery (Ulnar or Median Distribution)NCT01625208

Supraclavicular Versus Combined Block for Ulnar and Median Distribution Hand Surgery

A study testing Combined nerve block and Supraclavicular block in people with Hand Surgery (Ulnar or Median Distribution) and Peripheral Nerve Block, run by University of Alberta at 1 site in Canada.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Combined nerve block and Supraclavicular block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteCanada
Study dates
Mar 2012to Dec 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • University of Alberta Hospital

    Edmonton, Alberta

Other trials in Canada

About this study

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

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.

Read the detailed description

Background

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.

Purpose

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.

Hypothesis

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.

Study population

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.

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)

Methods

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

  1. Time to successful anesthetic block
  2. Procedural time
  3. Duration of analgesia
  4. Duration of weakness
  5. Patient satisfaction

Safety concerns

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.

Major concerns

  1. Pneumothorax
  2. Nerve damage
  3. Intravascular injection causing local anesthetic toxicity
  4. Infection

Minor concerns

  1. Block failure
  2. Transient hemidiaphragmatic paresis
  3. Transient Horner's syndrome
  4. Transient recurrent laryngeal nerve palsy
  5. Haematoma at injection site

Study Protocol

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.

Intra-operative management

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.

Block Assessment

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 collection

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.

Being tested
Combined nerve block, Supraclavicular block

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Combined nerve blockProcedure or surgery

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

  • Supraclavicular blockProcedure or surgery

    Standard supraclavicular brachial plexus block

Study groups in NCT01625208
Study groupRoleWhat they receive
Combined nerve blockExperimentalParticipants in this group will receive a supraclavicular brachial plexus block plus a median or ulnar nerve block.
Receives: Procedure: Combined nerve block
Single nerve blockActive comparatorParticipants in this group will receive a supraclavicular brachial plexus block only.
Receives: Procedure: Supraclavicular block

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (5)
  1. Time to successful anesthetic block from withdrawal of final needle

    The period between final withdrawal of the needle to successful nerve block following assessment will be timed.

    Measured: Approximately 20 minutes

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

    The period between initial placement and positioning of the ultrasound probe on the patient to final withdrawal of the needle will be timed.

    Measured: Approximately 30 minutes

  3. Duration of analgesia

    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.

    Measured: Approximately 6 hours

  4. Duration of motor blockade

    The time taken for the patient to recover motor capability in the area anesthetized following local anesthetic injection will be determined.

    Measured: Approximately one hour

  5. Patient satisfaction

    Patient satisfaction with reduction of pain and recovery of motor capability will be assessed in the 24-48 hour period following surgery.

    Measured: 24-48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionFeb 2013
  4. Study completionDec 2013

Why it stopped: No participants enrolled

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01625208
Sponsor's protocol ID
Pro00027213
Status last verified
Apr 2015
First submitted
19 Jun 2012
Last updated
25 Mar 2020
Results posted
No
Data monitoring committee
No

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. doi: 10.1097/00000542-200408000-00028.

    PubMed 15277930
  • 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.

    PubMed 19282715
  • 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.

    PubMed 8109769
  • 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.

    PubMed 19587618
  • 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.

    PubMed 21576095
  • 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.

    PubMed 15372385
  • 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.

    PubMed 19624628

Questions about this trial

What is this clinical trial studying?

A study testing Combined nerve block and Supraclavicular block in people with Hand Surgery (Ulnar or Median Distribution) and Peripheral Nerve Block, run by University of Alberta at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01625208, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.

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