Ignite Creation Date:
2024-05-06 @ 12:38 AM
Last Modification Date:
2024-10-26 @ 10:52 AM
Study NCT ID:
NCT01625208
Status:
WITHDRAWN
Last Update Posted:
2020-03-25
First Post:
2012-06-19
Brief Title:
Supraclavicular Versus Combined Block for Ulnar and Median Distribution Hand Surgery
Sponsor:
University of Alberta
Organization:
University of Alberta
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No participants enrolled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 andor 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 Horners 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 31 Lidocaine 2 05 Bupivacaine solution is injected A more superficial injection is then made A further 10-20 mls of the LidocaineBupivacaine 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 patients 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 50mcgkgminute will be commenced if required and the rate can be increased to 75mcgkgminute If the patient is unable to tolerate the procedure sedation can be increased to at least 100mcgkgminute 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 eg 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 75mcgkgmin
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
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 andor 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 Horners 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 31 Lidocaine 2 05 Bupivacaine solution is injected A more superficial injection is then made A further 10-20 mls of the LidocaineBupivacaine 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 patients 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 50mcgkgminute will be commenced if required and the rate can be increased to 75mcgkgminute If the patient is unable to tolerate the procedure sedation can be increased to at least 100mcgkgminute 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 eg 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 75mcgkgmin
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None