Nerve BlockNCT01485653
Dosage of Mepivacaine in Ultrasound Axillary Block
A study testing Mepivacaine in people with Nerve Block and Neuromuscular Blockade, run by Wayne State University.
Trial summary
The use of ultrasonography as an adjunct to regional anesthesia has significantly increased in recent years. Brachial plexus blockade by an axillary approach is amenable to the use of ultrasound guidance. Real time sonography of nerve structures ensures an optimal distribution of the block solution. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Nerve Block, Neuromuscular Blockade, Anesthesia
- What is being tested?
- Mepivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to Sep 2010
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Orthopedic forearm, wrist and hand surgery
- ASA I-III
- block procedure time less than 6 minutes
- pre-block sedation using less than 2 mcg fentanyl and less than .04 mg midazolam,
- patient consent to light pre-op sedation
Who cannot join
- Elbow/arm surgery longer than 2 hours
- ASA IV
- BMI greater than 35
- Pregnant patients
- history of CVA or scarring in the axillary to elbow area
- history of neurological impairment of either upper extremity
Show all 9Show fewer
- Any allergies to local anesthetics coagulopathy,
- infection at the site of block
- patients requiring opioid therapy for chronic pain
About this study
Official title: Effective Low Dosage of Mepivacaine in Ultrasound Guided Axillary Block in Patients Undergoing Distal Upper Extremity Surgery
The use of ultrasonography as an adjunct to regional anesthesia has significantly increased in recent years. Brachial plexus blockade by an axillary approach is amenable to the use of ultrasound guidance. Real time sonography of nerve structures ensures an optimal distribution of the block solution. When compared to other methods of nerve localization, sonography decreases: failure rate procedure time and the onset time for blockade. Furthermore, the use of ultrasound for peripheral nerve blockade demonstrates decreased procedure related complications such as nerve injury and unintentional vascular puncture.
Traditional axillary block techniques relying on surface anatomical landmarks require large volumes of local anesthetic, generally 40mL and greater. Utilizing the increased accuracy offered by ultrasound, some studies have shown that low volumes of local anesthetic can yield successful axillary plexus blockade. Therefore, the tradition of using large volumes of local anesthetic for axillary blocks, even without ultrasound, may not be warranted.
Although recent investigations support using a low volume of local anesthetic for brachial plexus blockade, there is a lack of outcome data from blinded randomised trials. The primary objective of this study was to evaluate 2 different volumes of local anesthetic for axillary blockade: 1) 20mL or 2) 30 mL. For the 2 different volumes used in this study, a 1.5% solution of mepivacaine was chosen due to its widespread clinical use in axillary blocks, which is secondary to: rapid onset of action, intermediate duration of effect, and relative low cost. The primary outcome was block success rate for outpatients undergoing distal upper limb surgery. Secondary objectives included comparing the 2 volumes with respect to: time required to perform the block, and onset of sensory and motor blockade.
Read the detailed description
Introduction
The use of ultrasonography as an adjunct to regional anesthesia has significantly increased in recent years. Brachial plexus blockade by an axillary approach is amenable to the use of ultrasound guidance. Real time sonography of nerve structures ensures an optimal distribution of the block solution. When compared to other methods of nerve localization, sonography decreases: failure rate procedure time and the onset time for blockade. Furthermore, the use of ultrasound for peripheral nerve blockade demonstrates decreased procedure related complications such as nerve injury and unintentional vascular puncture.
Traditional axillary block techniques relying on surface anatomical landmarks require large volumes of local anesthetic, generally 40mL and greater. Utilizing the increased accuracy offered by ultrasound, some studies have shown that low volumes of local anesthetic can yield successful axillary plexus blockade. Therefore, the tradition of using large volumes of local anesthetic for axillary blocks, even without ultrasound, may not be warranted.
Although recent investigations support using a low volume of local anesthetic for brachial plexus blockade, there is a lack of outcome data from blinded randomised trials. The primary objective of this study was to evaluate 2 different volumes of local anesthetic for axillary blockade: 1) 20mL or 2) 30 mL. For the 2 different volumes used in this study, a 1.5% solution of mepivacaine was chosen due to its widespread clinical use in axillary blocks, which is secondary to: rapid onset of action, intermediate duration of effect, and relative low cost. The primary outcome was block success rate for outpatients undergoing distal upper limb surgery. Secondary objectives included comparing the 2 volumes with respect to: time required to perform the block, and onset of sensory and motor blockade.
Methods
This pilot study was a prospective, double blinded, randomized trial of 64 patients recruited from the Detroit Receiving Hospital, Detroit, MI. All patients were scheduled to undergo upper limb surgery in an outpatient setting. Upon obtaining written informed consent, patients were randomly assigned to receive either 20mL (n=31) or 30mL (n=33) of a 1.5% mepivacaine solution for axillary plexus blockade. All anesthetic blocks were placed using standard medical protocol. Nerve localization was performed using a GE LOGIQe ultrasound machine (GE Medical systems, Milwaukee, Wis, USA), with a 12L-RS transducer (42mm x 7mm footprint, 5-13 MHz). Following identification of the axillary neurovascular bundle, a 22G x 50 mm poly medic UPC electric stimulation needle was inserted and advanced along the longitudinal axis of the ultrasound transducer so that the entire shaft and tip could be visualized. A peri-arterial injection of 1.5% mepivacaine in the vicinity of the individual nerve sheaths was performed after negative aspiration. The end point being the circumferential "donut sign" spread around the artery. Additionally, the musculocutaneous nerve was identified and 1.5% mepivacaine was injected around the nerve. Depending on the patient group allocation either 20mL or 30 mL total of 1.5% mepivacaine was infiltrated. For the group receiving 20mL, 15 of the total 20 mL was spread around the axillary artery and 5mL spread around the musculocutaneous nerve. For the group receiving 30mL, 20 of the total 30 mL was spread around the axillary artery and 10mL was spread around the musculocutaneous nerve. By instituting this injection technique, results could be extrapolated to non ultrasound guided axillary blocks.
Inclusion Criteria All subjects recruited into the study were patients undergoing forearm, wrist, or hand surgery, in an outpatient setting. Other attributes included: ASA I-III, BMI < 35, and age between 18-89 years. All subjects had no history of: CVA, diabetes, anxiety disorder, obstructive sleep apnea, previous surgery or scarring in the axillary to elbow area, neurological impairment of either upper extremity, allergies to local anesthesia, coagulopathy, infection at site of block, chronic opioid therapy for chronic pain, casts or dressing on the limb that would impair assessment of blocks. Pre-block sedation using < 0.8mg/kg midazolam and no administration of preoperative opioids. Block procedure time < 10min. Subjects consented to light intraoperative sedation.
Data collection Preoperatively: Demographics, ASA (marker for surgical risk), height, weight, surgical procedure, location of procedure (hand, wrist, forearm), sedation used in preoperative holding area, the amount of versed used, block start and end time (duration of time taken between needle insertion and extraction), onset of sensory blockade, onset of motor blockade.
Intraoperatively: Conversion to general anesthesia, use of local anesthesia intraoperatively, total amount of propofol administered, surgical incision time, surgery end time.
Postoperative: Complications related to axillary block. Discharge criteria met.
Onset of Sensory blockade: Examined every 5 minutes following needle extraction using a blunt needle at 4 specific anatomic locations corresponding to radial, ulnar, median, and musculocutaneous distributions and compared with contralateral side using same stimulus. Normal pinprick sharp, 3; pinprick felt but not as sharp, 2; pressure felt but no pinprick felt, 1; no sensation at all, 0.
Onset of Motor Blockade: Examined every 5 minutes following needle extraction. Wrist flexion: median nerve; wrist extension: radial nerve; abduction of 5th finger or straight finger adduction: ulnar nerve; elbow flexion (with forearm supinated): musculocutaneous nerve. Normal strength, 3; decreased strength but moves against gravity or some resistance, 2; no movement against gravity or twitch, 1; no movement at all, 0.
Definitions of successful block Functional successful block: Sensory score of 0-1 in all 4 territories and motor score of 0-1 in 3 of 4 territories within 30 minutes of needle extraction.
Surgical successful block: no required intraoperative supplemental local anesthetic, light sedation <25mcg/kg/min propofol and absence of general endotracheal anesthesia.
Statistics
An unpaired students-t-test procedure (two-sample assuming equal variances, two-tail significance p<0.05, 95% confidence interval) was performed to examine mean differences between the 2 study groups on all continuously scaled variables. A repeated measures ANOVA was used to measure differences between both groups over time for motor and sensory nerve block scores at the 6 measured time points (5 min, 10 min, 15 min, 20min, 25 min and 30 min). Assumptions of normality and/or homogeneity of variance were checked and verified. Comparisons between study groups on proportional differences were examined using a non-parametric Fisher's Exact Chi-square test, when applied to 2x2 and 2x3 tables. Statistical significance was set at a p-value ≤0.05. All continuous data is expressed as mean with 95% upper and lower confidence intervals.
- Conditions
- Nerve Block, Neuromuscular Blockade, Anesthesia
- Being tested
- Mepivacaine
- Keywords
- Brachial Plexus, Mepivacaine, Ultrasound, Axillary, Block
- Medical subject headings
- Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MepivacaineDrug
Group 1) 20mL 1.5% mepivacaine, one dose Group 2) 30mL 1.5% mepivacaine, one dose
| Study group | Role | What they receive |
|---|---|---|
| Mepivacaine, Ultrasound Axillary Block | Experimental | Group 1) 20mL 1.5% mepivacaine Group 2) 30mL 1.5% mepivacaine Receives: Drug: Mepivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Block
Definitions of successful block Functional successful block: Sensory score of 0-1 in all 4 territories and motor score of 0-1 in 3 of 4 territories within 30 minutes of needle extraction.
Surgical successful block: no required intraoperative supplemental local anesthetic, light sedation <25mcg/kg/min propofol and absence of general endotracheal anesthesia.
Measured: 30 minutes
Secondary outcomes (2)
Time required until onset of sensory blockade.
Onset of Sensory blockade: Examined every 5 minutes following needle extraction using a blunt needle at 4 specific anatomic locations corresponding to radial, ulnar, median, and musculocutaneous distributions and compared with contralateral side using same stimulus.
Onset of Motor Blockade: Examined every 5 minutes following needle extraction. Wrist flexion: median nerve; wrist extension: radial nerve; abduction of 5th finger or straight finger adduction: ulnar nerve; elbow flexion (with forearm supinated): musculocutaneous nerve.
Measured: 30 minutes
Time taken until Onset of Motor Blockade
Onset of Motor Blockade: Examined every 5 minutes following needle extraction. Wrist flexion: median nerve; wrist extension: radial nerve; abduction of 5th finger or straight finger adduction: ulnar nerve; elbow flexion (with forearm supinated): musculocutaneous nerve.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2011 (estimated)
- Study startApr 2010
- Primary completionAug 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve BlockStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel Perov, Wayne State University
- Investigators
- Samuel Perov, M.D., Principal investigator, Wayne State University, Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01485653
- Sponsor's protocol ID
- WSU irb# 0902006824
- Other IDs
- need to get
- Status last verified
- Dec 2011
- First submitted
- 23 Nov 2011
- Last updated
- 8 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective Low Dosage of Mepivacaine in Ultrasound Guided Axillary Block in Patients Undergoing Distal Upper Extremity Surgery
- ClinicalTrials.gov ID
- NCT01485653
- Acronym / sponsor ID
- WSU irb# 0902006824
- Conditions
- Nerve Block, Neuromuscular Blockade, Anesthesia
- Keywords
- Brachial Plexus, Mepivacaine, Ultrasound, Axillary, Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 5 Dec 2011 (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.
The use of ultrasonography as an adjunct to regional anesthesia has significantly increased in recent years. Brachial plexus blockade by an axillary approach is amenable to the use of ultrasound guidance. Real time sonography of nerve structures ensures an optimal distribution of the block solution. When compared to other methods of nerve localization, sonography decreases: failure rate procedure time and the onset time for blockade. Furthermore, the use of ultrasound for peripheral nerve blockade demonstrates decreased procedure related complications such as nerve injury and unintentional vascular puncture.
Traditional axillary block techniques relying on surface anatomical landmarks require large volumes of local anesthetic, generally 40mL and greater. Utilizing the increased accuracy offered by ultrasound, some studies have shown that low volumes of local anesthetic can yield successful axillary plexus blockade. Therefore, the tradition of using large volumes of local anesthetic for axillary blocks, even without ultrasound, may not be warranted.
Although recent investigations support using a low volume of local anesthetic for brachial plexus blockade, there is a lack of outcome data from blinded randomised trials. The primary objective of this study was to evaluate 2 different volumes of local anesthetic for axillary blockade: 1) 20mL or 2) 30 mL. For the 2 different volumes used in this study, a 1.5% solution of mepivacaine was chosen due to its widespread clinical use in axillary blocks, which is secondary to: rapid onset of action, intermediate duration of effect, and relative low cost. The primary outcome was block success rate for outpatients undergoing distal upper limb surgery. Secondary objectives included comparing the 2 volumes with respect to: time required to perform the block, and onset of sensory and motor blockade.
Detailed description
Introduction
The use of ultrasonography as an adjunct to regional anesthesia has significantly increased in recent years. Brachial plexus blockade by an axillary approach is amenable to the use of ultrasound guidance. Real time sonography of nerve structures ensures an optimal distribution of the block solution. When compared to other methods of nerve localization, sonography decreases: failure rate procedure time and the onset time for blockade. Furthermore, the use of ultrasound for peripheral nerve blockade demonstrates decreased procedure related complications such as nerve injury and unintentional vascular puncture.
Traditional axillary block techniques relying on surface anatomical landmarks require large volumes of local anesthetic, generally 40mL and greater. Utilizing the increased accuracy offered by ultrasound, some studies have shown that low volumes of local anesthetic can yield successful axillary plexus blockade. Therefore, the tradition of using large volumes of local anesthetic for axillary blocks, even without ultrasound, may not be warranted.
Although recent investigations support using a low volume of local anesthetic for brachial plexus blockade, there is a lack of outcome data from blinded randomised trials. The primary objective of this study was to evaluate 2 different volumes of local anesthetic for axillary blockade: 1) 20mL or 2) 30 mL. For the 2 different volumes used in this study, a 1.5% solution of mepivacaine was chosen due to its widespread clinical use in axillary blocks, which is secondary to: rapid onset of action, intermediate duration of effect, and relative low cost. The primary outcome was block success rate for outpatients undergoing distal upper limb surgery. Secondary objectives included comparing the 2 volumes with respect to: time required to perform the block, and onset of sensory and motor blockade.
Methods
This pilot study was a prospective, double blinded, randomized trial of 64 patients recruited from the Detroit Receiving Hospital, Detroit, MI. All patients were scheduled to undergo upper limb surgery in an outpatient setting. Upon obtaining written informed consent, patients were randomly assigned to receive either 20mL (n=31) or 30mL (n=33) of a 1.5% mepivacaine solution for axillary plexus blockade. All anesthetic blocks were placed using standard medical protocol. Nerve localization was performed using a GE LOGIQe ultrasound machine (GE Medical systems, Milwaukee, Wis, USA), with a 12L-RS transducer (42mm x 7mm footprint, 5-13 MHz). Following identification of the axillary neurovascular bundle, a 22G x 50 mm poly medic UPC electric stimulation needle was inserted and advanced along the longitudinal axis of the ultrasound transducer so that the entire shaft and tip could be visualized. A peri-arterial injection of 1.5% mepivacaine in the vicinity of the individual nerve sheaths was performed after negative aspiration. The end point being the circumferential "donut sign" spread around the artery. Additionally, the musculocutaneous nerve was identified and 1.5% mepivacaine was injected around the nerve. Depending on the patient group allocation either 20mL or 30 mL total of 1.5% mepivacaine was infiltrated. For the group receiving 20mL, 15 of the total 20 mL was spread around the axillary artery and 5mL spread around the musculocutaneous nerve. For the group receiving 30mL, 20 of the total 30 mL was spread around the axillary artery and 10mL was spread around the musculocutaneous nerve. By instituting this injection technique, results could be extrapolated to non ultrasound guided axillary blocks.
Inclusion Criteria All subjects recruited into the study were patients undergoing forearm, wrist, or hand surgery, in an outpatient setting. Other attributes included: ASA I-III, BMI < 35, and age between 18-89 years. All subjects had no history of: CVA, diabetes, anxiety disorder, obstructive sleep apnea, previous surgery or scarring in the axillary to elbow area, neurological impairment of either upper extremity, allergies to local anesthesia, coagulopathy, infection at site of block, chronic opioid therapy for chronic pain, casts or dressing on the limb that would impair assessment of blocks. Pre-block sedation using < 0.8mg/kg midazolam and no administration of preoperative opioids. Block procedure time < 10min. Subjects consented to light intraoperative sedation.
Data collection Preoperatively: Demographics, ASA (marker for surgical risk), height, weight, surgical procedure, location of procedure (hand, wrist, forearm), sedation used in preoperative holding area, the amount of versed used, block start and end time (duration of time taken between needle insertion and extraction), onset of sensory blockade, onset of motor blockade.
Intraoperatively: Conversion to general anesthesia, use of local anesthesia intraoperatively, total amount of propofol administered, surgical incision time, surgery end time.
Postoperative: Complications related to axillary block. Discharge criteria met.
Onset of Sensory blockade: Examined every 5 minutes following needle extraction using a blunt needle at 4 specific anatomic locations corresponding to radial, ulnar, median, and musculocutaneous distributions and compared with contralateral side using same stimulus. Normal pinprick sharp, 3; pinprick felt but not as sharp, 2; pressure felt but no pinprick felt, 1; no sensation at all, 0.
Onset of Motor Blockade: Examined every 5 minutes following needle extraction. Wrist flexion: median nerve; wrist extension: radial nerve; abduction of 5th finger or straight finger adduction: ulnar nerve; elbow flexion (with forearm supinated): musculocutaneous nerve. Normal strength, 3; decreased strength but moves against gravity or some resistance, 2; no movement against gravity or twitch, 1; no movement at all, 0.
Definitions of successful block Functional successful block: Sensory score of 0-1 in all 4 territories and motor score of 0-1 in 3 of 4 territories within 30 minutes of needle extraction.
Surgical successful block: no required intraoperative supplemental local anesthetic, light sedation <25mcg/kg/min propofol and absence of general endotracheal anesthesia.
Statistics
An unpaired students-t-test procedure (two-sample assuming equal variances, two-tail significance p<0.05, 95% confidence interval) was performed to examine mean differences between the 2 study groups on all continuously scaled variables. A repeated measures ANOVA was used to measure differences between both groups over time for motor and sensory nerve block scores at the 6 measured time points (5 min, 10 min, 15 min, 20min, 25 min and 30 min). Assumptions of normality and/or homogeneity of variance were checked and verified. Comparisons between study groups on proportional differences were examined using a non-parametric Fisher's Exact Chi-square test, when applied to 2x2 and 2x3 tables. Statistical significance was set at a p-value ≤0.05. All continuous data is expressed as mean with 95% upper and lower confidence intervals.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mepivacaine, Ultrasound Axillary Block | Experimental | Drug: MepivacaineGroup 1) 20mL 1.5% mepivacaine Group 2) 30mL 1.5% mepivacaine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Orthopedic forearm, wrist and hand surgery
- ASA I-III
- block procedure time less than 6 minutes
- pre-block sedation using less than 2 mcg fentanyl and less than .04 mg midazolam,
- patient consent to light pre-op sedation
Key exclusion criteria (9 listed)
- Elbow/arm surgery longer than 2 hours
- ASA IV
- BMI greater than 35
- Pregnant patients
- history of CVA or scarring in the axillary to elbow area
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 |
|---|---|---|
| MepivacaineGroup 1) 20mL 1.5% mepivacaine, one dose Group 2) 30mL 1.5% mepivacaine, one dose | Drug | Mepivacaine, Ultrasound Axillary Block |
Primary outcome
Successful Block
Time frame: 30 minutes
Definitions of successful block Functional successful block: Sensory score of 0-1 in all 4 territories and motor score of 0-1 in 3 of 4 territories within 30 minutes of needle extraction. Surgical successful block: no required intraoperative supplemental local anesthetic, light sedation <25mcg/kg/min propofol and absence of general endotracheal anesthesia.
2 secondary outcomes
Time required until onset of sensory blockade.
Time frame: 30 minutes
Time taken until Onset of Motor Blockade
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2011.
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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.
Samuel Perov, M.D. principal investigator
Wayne State University, Department of Anesthesiology
Questions about this trial
What is this clinical trial studying?
A study testing Mepivacaine in people with Nerve Block and Neuromuscular Blockade, run by Wayne State University.
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 5 inclusion and 9 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: finished, as of the sponsor's last update on 8 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Block (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Dec 2011.