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.
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
- Conditions the study is for
- Hand Surgery (Ulnar or Median Distribution), Peripheral Nerve Block
- 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.
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
- Successful surgical anesthesia
Secondary outcome measures
- Time to successful anesthetic block
- Procedural time
- Duration of analgesia
- Duration of weakness
- 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
- Pneumothorax
- Nerve damage
- Intravascular injection causing local anesthetic toxicity
- Infection
Minor concerns
- Block failure
- Transient hemidiaphragmatic paresis
- Transient Horner's syndrome
- Transient recurrent laryngeal nerve palsy
- 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 group | Role | What they receive |
|---|---|---|
| Combined nerve block | Experimental | Participants in this group will receive a supraclavicular brachial plexus block plus a median or ulnar nerve block. Receives: Procedure: Combined nerve block |
| Single nerve block | Active comparator | Participants 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.
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)
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
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
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
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
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.
- First posted21 Jun 2012 (estimated)
- Study startMar 2012
- Primary completionFeb 2013
- Study completionDec 2013
Why it stopped: No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Hand Surgery (Ulnar or Median Distribution)Studies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Cameron, MD, Principal investigator, University of Alberta
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 15277930Perlas 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 19282715Kapral 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 8109769Duggan 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 19587618Fredrickson 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 21576095Hadzic 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 15372385Fredrickson 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01625208
- Acronym / sponsor ID
- Pro00027213
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Mar 2012 (actual)
- Primary completion
- Feb 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 21 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Successful surgical anesthesia
Secondary outcome measures
- Time to successful anesthetic block
- Procedural time
- Duration of analgesia
- Duration of weakness
- 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
- Pneumothorax
- Nerve damage
- Intravascular injection causing local anesthetic toxicity
- Infection
Minor concerns
- Block failure
- Transient hemidiaphragmatic paresis
- Transient Horner's syndrome
- Transient recurrent laryngeal nerve palsy
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined nerve block | Experimental | Procedure: Combined nerve blockParticipants in this group will receive a supraclavicular brachial plexus block plus a median or ulnar nerve block. |
| Single nerve block | Active comparator | Procedure: Supraclavicular blockParticipants in this group will receive a supraclavicular brachial plexus block only. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- Patient refusal
- Allergy to amide local anesthetics
- Severe coagulopathy
- Bilateral upper limb surgery
- Surgery involving bone graft from the iliac crest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined nerve blockCombined supraclavicular brachial plexus block plus ulnar or median nerve block (depending on the location of surgery) | Procedure or surgery | Combined nerve block |
| Supraclavicular blockStandard supraclavicular brachial plexus block | Procedure or surgery | Single nerve block |
Primary outcome
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.
5 secondary outcomes
Time to successful anesthetic block from withdrawal of final needle
Time frame: Approximately 20 minutes
Time for procedure, from placement of probe on skin to withdrawal of needle
Time frame: Approximately 30 minutes
Duration of analgesia
Time frame: Approximately 6 hours
Duration of motor blockade
Time frame: Approximately one hour
Patient satisfaction
Time frame: 24-48 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Background: PubMed 15277930McCartney 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.
- Background: PubMed 19282715Perlas 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.
- Background: PubMed 8109769Kapral 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.
- Background: PubMed 19587618Duggan 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.
- Background: PubMed 21576095Fredrickson 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.
- Background: PubMed 15372385Hadzic 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.
- Background: PubMed 19624628Fredrickson 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Cameron, MD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
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.