Hand SurgeryNCT05325372
A Comparative Study Between Infraclavicular and Axillary Blocks for Assessment of Motor Power Using Handgrip Dynamometer
A study testing axillary block and infraclavicular block in people with Hand Surgery and Ultrasound Guided, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
Hand Surgery is surgery of the hand, the wrist, and the peripheral nerves of the upper limb. Many different types of surgeries can be performed on the hand, depending on the underlying cause of the problem such as Closed reduction and fixation, Tendon repair, Skin grafts, Skin flaps, Carpal Tunnel Release, and… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hand Surgery, Ultrasound Guided
- What is being tested?
- axillary block and infraclavicular block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2022to 26 Apr 2023
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Gender both males and females
- ASA Class I, II
- Age 18-60 years
- Patients undergoing minor hand surgery (skin graft, Carpal Tunnel Release, ganglion removal, and lipoma ) expected surgical time of more than 15 min and less than one hour.
Who cannot join
- Allergy to local anesthetic
- Infection of the skin at the site of block.
- Bilateral surgery, neck and clavicle deformities, existing neurological disease chronic pain diagnosis, pre-existing nerve damage, muscle injuries, and tendon injury.
- Coagulopathy, previous surgery on the operative limb, inability to comprehend study-related procedures, and clinically significant cognitive impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study Between the Ultrasound-guided Infraclavicular Block and Axillary Block for Assessment of Motor Power Degree and Duration Using Handgrip Dynamometer in Patients Undergoing Minor Hand Surgery. A Randomized Control Trial
Hand Surgery is surgery of the hand, the wrist, and the peripheral nerves of the upper limb. Many different types of surgeries can be performed on the hand, depending on the underlying cause of the problem such as Closed reduction and fixation, Tendon repair, Skin grafts, Skin flaps, Carpal Tunnel Release, and ganglion removal. Hand surgery is usually associated with marked postoperative pain. Ultrasound-guided regional anesthesia is usually performed in patients undergoing hand surgery.
This study aims to compare Ultrasound-guided infraclavicular block and axillary block and assess the degree of motor power and duration by testing hand grip strength using a hydraulic hand dynamometer in patients undergoing hand surgery.
Read more
Objectives:
To determine the degree of a motor block using a hydraulic hand dynamometer. To Estimate time needed to regain full motor activity. To identify whether ultrasound-guided axillary block may preserve motor function to a greater extent than infraclavicular blocks.
Read the detailed description
This randomized control trial is designed to include (52) patients ASA physical status I, II patients ranging from(18) to(60)years old scheduled for hand surgery
Patients meeting the inclusion criteria will be randomly assigned to receive either:
Group I: axillary block technique (n=26) (group A) GroupII: infraclavicular block technique( n=26)(group B) Anesthesia management After arrival to the anesthetic room, An 18-gauge intravenous cannula will be placed at the forearm contralateral to the operated arm, standard monitoring will be used (non-invasive arterial blood pressure, ECG, pulse oximetry) while performing the block and throughout the surgical procedure. Premedication will be given intravenously in the form of 0.03 mg/kg midazolam. 1 g paracetamol iv will be given for all patients Under aseptic conditions, a preliminary scan will be performed using siemens acuson x 300 ultrasound with 8-14 MHz linear transducer. A 50-mm block needle 22 gauge will be used. (SonoPlex Stim Cannula, Germany) All blocks will be given by one researcher using 20 ml of drug 0.25% bupivacaine (10 ml 0.5% bupivacaine + 10 ml normal saline).
Axillary block
Patients in group A will be placed in the supine position with the arm to be blocked abducted and externally rotated. After sterilization of the axilla, the Ultrasound probe with a linear high frequency (8-14 MHZ) transducer will be placed parallel to the anterior axillary fold at the axilla to identify the axillary artery and to identify the hyperechoic median, ulnar, and radial nerves in relation to the axillary artery. The musculocutaneous nerve which supplies the skin of the lateral side of the forearm had to be blocked also. It is found between the biceps brachii and coracobrachialis muscles. Lidocaine 1% was infiltrated subcutaneously 1 cm lateral to the probe. The needle is inserted in-plane from the anterior aspect and directed toward the posterior aspect of the axillary artery. All four nerves in the axillary region will be blocked. A local anesthetic will be administered adjacent to each of the four nerves (at least 5 ml for each).
Infraclavicular block
Patients in group B will be placed in the supine position with the head turned away from the side to be blocked. The arm is abducted to 90 degrees and the elbow flexed. the skin is disinfected and the transducer is positioned in the parasagittal plane to identify the axillary artery. Surrounding the artery are the three cords of the brachial plexus: the lateral, posterior, and medial cords. The needle is inserted in-plane short-axis technique from the cephalad end of the probe, with the insertion point just inferior to the clavicle. A local anesthetic will be injected posterior to the axillary artery to achieve a U-shaped distribution around the artery (cephalad, caudad, and posterior).
Injection of 5 ml lidocaine 2% will be also used in all patients to eliminate tourniquet pain and pain in the area of distribution of intercostobrachial nerve in case of use of a tourniquet
Block assessment
After completion of all block procedures. A formal assessment of block efficacy will be performed by an independent observer who will be masked to each subject's group allocation every 10 min after needle removal for 30 min. surgery will be started once surgical anesthesia will be achieved at any time point or until 30 min had elapsed. if surgical anesthesia will not be achieved at 30 min the block will be considered failed and general anesthesia will proceed.
Sensory blockade of the musculocutaneous, median, radial and ulnar nerves will be graded according to the previously validated 3 point scale using a cold test: respectively: 0 = no perception, 1 = decreased sensation, or 2 = normal sensation. A successful blockade is defined as a complete sensory blockade (i.e., sensory block score = 0) within 30 minutes of completing the block. If complete sensory blockade will not be achieved within 30 minutes, the affected subject will be excluded from the study and categorized as a block failure. The subject was offered a supplementary nerve block if there is sufficient time before surgery, or general anesthesia will be proceeded to achieve surgical anesthesia.
The procedural time (seconds) for each block will be recorded. This duration is defined as the interval from the ultrasound transducer's first contact with the subject to the time the block needle exit the skin. Block onset time will be recorded (from a completed injection of local anesthetic until loss of cold sensation) Duration of the block will be recorded, defined as the time from completing injection of the local anesthetic till complete recovery of sensory function, i.e., the cold test will be assessed every 30 min in the postoperative period till patient feel the cold sensation
The motor blockade will be assessed by testing patients' handgrip strength using a hydraulic handgrip dynamometer, baseline measurements will be recorded on both the ipsilateral and contralateral sides. hand grip strength will be measured preoperative, 30 min from a block, and after surgery. postoperative change in handgrip strength in the operative limb as a percent reduction of preoperative baseline strength will be measured. The time needed to regain full motor power will be measured.
All patients will be postoperatively monitored in the post-anesthesia care unit (PACU) for 1 h and thereafter discharged to their wards. Post-operative pain at the incision site will be assessed by visual analog scale (VAS) and a score of more than 3 when recorded will be taken as an endpoint for the duration of block and the patient was given supplementary analgesics i.e. Inj. Diclofenac Sodium 1-1.5 mg/kg intramuscular. Subject satisfaction will be assessed with a standardized question scored on a seven-point Likert scale: "Thinking about your nerve blocks, how satisfied were you with them: where 1 is not at all, 4 is neutral, and 7 is completely satisfied?"
Block related complications will be recorded such as failed block, motor weakness 24 h after the block local anesthetic toxicity, vascular puncture, paraesthesia, and pneumothorax.
- Conditions
- Hand Surgery, Ultrasound Guided
- Being tested
- axillary block, infraclavicular block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
axillary blockProcedure or surgery
Also called peripheral nerve block
it will be given using 20 ml of drug 0.25% bupivacaine (10 ml 0.5% bupivacaine + 10 ml normal saline).
infraclavicular blockProcedure or surgery
Also called peripheral nerve block
it will be given using 20 ml of drug 0.25% bupivacaine (10 ml 0.5% bupivacaine + 10 ml normal saline).
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound guided axillary block | Experimental | the Ultrasound probe with a linear high frequency (8-14 MHZ) transducer will be placed parallel to the anterior axillary fold at the axilla to identify the axillary artery and to identify the hyperechoic median, ulnar, and radial nerves in relation to the axillary artery. The musculocutaneous nerve which supplies the skin of the lateral side of the forearm had to be blocked also. It is found between the biceps brachii and coracobrachialis muscles. Lidocaine 1% was infiltrated subcutaneously 1 cm lateral to the probe. The needle is inserted in-plane from the anterior aspect and directed toward the posterior aspect of the axillary artery. All four nerves in the axillary region will be blocked. A local anesthetic will be administered adjacent to each of the four nerves (at least 5 ml for each). Receives: Procedure: axillary block |
| Ultrasound guided infraclavicular block block | Experimental | The transducer is positioned in the parasagittal plane to identify the axillary artery. Surrounding the artery are the three cords of the brachial plexus: the lateral, posterior, and medial cords. The needle is inserted in-plane short-axis technique from the cephalad end of the probe, with the insertion point just inferior to the clavicle. A local anesthetic will be injected posterior to the axillary artery to achieve a U-shaped distribution around the artery (cephalad, caudad, and posterior). Receives: Procedure: infraclavicular block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative change in handgrip strength in the operative limb
Postoperative change in handgrip strength in the operative limb as a percent reduction of preoperative baseline strength at 90 min from the block (%)
Measured: it will be measured at 90 min from the block
Secondary outcomes (1)
Block related complications
local anesthetic toxicity, vascular puncture, paresthesia, and pneumothorax
Measured: it will be measured in the first 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start15 Apr 2022
- Primary completion26 Apr 2023
- Study completion26 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand SurgeryStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Ahmed nabih youssef, Kasr El Aini Hospital
- Investigators
- Yasser EL Halafawy, professor, Study director, Anesthesia department , Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05325372
- Sponsor's protocol ID
- MS-529-2021
- Status last verified
- Apr 2023
- First submitted
- 6 Apr 2022
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between the Ultrasound-guided Infraclavicular Block and Axillary Block for Assessment of Motor Power Degree and Duration Using Handgrip Dynamometer in Patients Undergoing Minor Hand Surgery. A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05325372
- Acronym / sponsor ID
- MS-529-2021
- Conditions
- Hand Surgery, Ultrasound Guided
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 26 Apr 2023 (actual)
- Study completion
- 26 Apr 2023 (actual)
- First posted
- 13 Apr 2022 (actual)
- 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.
Hand Surgery is surgery of the hand, the wrist, and the peripheral nerves of the upper limb. Many different types of surgeries can be performed on the hand, depending on the underlying cause of the problem such as Closed reduction and fixation, Tendon repair, Skin grafts, Skin flaps, Carpal Tunnel Release, and ganglion removal. Hand surgery is usually associated with marked postoperative pain. Ultrasound-guided regional anesthesia is usually performed in patients undergoing hand surgery.
This study aims to compare Ultrasound-guided infraclavicular block and axillary block and assess the degree of motor power and duration by testing hand grip strength using a hydraulic hand dynamometer in patients undergoing hand surgery.
Objectives:
To determine the degree of a motor block using a hydraulic hand dynamometer. To Estimate time needed to regain full motor activity. To identify whether ultrasound-guided axillary block may preserve motor function to a greater extent than infraclavicular blocks.
Detailed description
This randomized control trial is designed to include (52) patients ASA physical status I, II patients ranging from(18) to(60)years old scheduled for hand surgery
Patients meeting the inclusion criteria will be randomly assigned to receive either:
Group I: axillary block technique (n=26) (group A) GroupII: infraclavicular block technique( n=26)(group B) Anesthesia management After arrival to the anesthetic room, An 18-gauge intravenous cannula will be placed at the forearm contralateral to the operated arm, standard monitoring will be used (non-invasive arterial blood pressure, ECG, pulse oximetry) while performing the block and throughout the surgical procedure. Premedication will be given intravenously in the form of 0.03 mg/kg midazolam. 1 g paracetamol iv will be given for all patients Under aseptic conditions, a preliminary scan will be performed using siemens acuson x 300 ultrasound with 8-14 MHz linear transducer. A 50-mm block needle 22 gauge will be used. (SonoPlex Stim Cannula, Germany) All blocks will be given by one researcher using 20 ml of drug 0.25% bupivacaine (10 ml 0.5% bupivacaine + 10 ml normal saline).
Axillary block
Patients in group A will be placed in the supine position with the arm to be blocked abducted and externally rotated. After sterilization of the axilla, the Ultrasound probe with a linear high frequency (8-14 MHZ) transducer will be placed parallel to the anterior axillary fold at the axilla to identify the axillary artery and to identify the hyperechoic median, ulnar, and radial nerves in relation to the axillary artery. The musculocutaneous nerve which supplies the skin of the lateral side of the forearm had to be blocked also. It is found between the biceps brachii and coracobrachialis muscles. Lidocaine 1% was infiltrated subcutaneously 1 cm lateral to the probe. The needle is inserted in-plane from the anterior aspect and directed toward the posterior aspect of the axillary artery. All four nerves in the axillary region will be blocked. A local anesthetic will be administered adjacent to each of the four nerves (at least 5 ml for each).
Infraclavicular block
Patients in group B will be placed in the supine position with the head turned away from the side to be blocked. The arm is abducted to 90 degrees and the elbow flexed. the skin is disinfected and the transducer is positioned in the parasagittal plane to identify the axillary artery. Surrounding the artery are the three cords of the brachial plexus: the lateral, posterior, and medial cords. The needle is inserted in-plane short-axis technique from the cephalad end of the probe, with the insertion point just inferior to the clavicle. A local anesthetic will be injected posterior to the axillary artery to achieve a U-shaped distribution around the artery (cephalad, caudad, and posterior).
Injection of 5 ml lidocaine 2% will be also used in all patients to eliminate tourniquet pain and pain in the area of distribution of intercostobrachial nerve in case of use of a tourniquet
Block assessment
After completion of all block procedures. A formal assessment of block efficacy will be performed by an independent observer who will be masked to each subject's group allocation every 10 min after needle removal for 30 min. surgery will be started once surgical anesthesia will be achieved at any time point or until 30 min had elapsed. if surgical anesthesia will not be achieved at 30 min the block will be considered failed and general anesthesia will proceed.
Sensory blockade of the musculocutaneous, median, radial and ulnar nerves will be graded according to the previously validated 3 point scale using a cold test: respectively: 0 = no perception, 1 = decreased sensation, or 2 = normal sensation. A successful blockade is defined as a complete sensory blockade (i.e., sensory block score = 0) within 30 minutes of completing the block. If complete sensory blockade will not be achieved within 30 minutes, the affected subject will be excluded from the study and categorized as a block failure. The subject was offered a supplementary nerve block if there is sufficient time before surgery, or general anesthesia will be proceeded to achieve surgical anesthesia.
The procedural time (seconds) for each block will be recorded. This duration is defined as the interval from the ultrasound transducer's first contact with the subject to the time the block needle exit the skin. Block onset time will be recorded (from a completed injection of local anesthetic until loss of cold sensation) Duration of the block will be recorded, defined as the time from completing injection of the local anesthetic till complete recovery of sensory function, i.e., the cold test will be assessed every 30 min in the postoperative period till patient feel the cold sensation
The motor blockade will be assessed by testing patients' handgrip strength using a hydraulic handgrip dynamometer, baseline measurements will be recorded on both the ipsilateral and contralateral sides. hand grip strength will be measured preoperative, 30 min from a block, and after surgery. postoperative change in handgrip strength in the operative limb as a percent reduction of preoperative baseline strength will be measured. The time needed to regain full motor power will be measured.
All patients will be postoperatively monitored in the post-anesthesia care unit (PACU) for 1 h and thereafter discharged to their wards. Post-operative pain at the incision site will be assessed by visual analog scale (VAS) and a score of more than 3 when recorded will be taken as an endpoint for the duration of block and the patient was given supplementary analgesics i.e. Inj. Diclofenac Sodium 1-1.5 mg/kg intramuscular. Subject satisfaction will be assessed with a standardized question scored on a seven-point Likert scale: "Thinking about your nerve blocks, how satisfied were you with them: where 1 is not at all, 4 is neutral, and 7 is completely satisfied?"
Block related complications will be recorded such as failed block, motor weakness 24 h after the block local anesthetic toxicity, vascular puncture, paraesthesia, and pneumothorax.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound guided axillary block | Experimental | Procedure: axillary blockthe Ultrasound probe with a linear high frequency (8-14 MHZ) transducer will be placed parallel to the anterior axillary fold at the axilla to identify the axillary artery and to identify the hyperechoic median, ulnar, and radial nerves in relation to the axillary artery. The musculocutaneous nerve which supplies the skin of the lateral side of the forearm had to be blocked also. It is found between the biceps brachii and coracobrachialis muscles. Lidocaine 1% was infiltrated subcutaneously 1 cm lateral to the probe. The needle is inserted in-plane from the anterior aspect and directed toward the posterior aspect of the axillary artery. All four nerves in the axillary region will be blocked. A local anesthetic will be administered adjacent to each of the four nerves (at least 5 ml for each). |
| Ultrasound guided infraclavicular block block | Experimental | Procedure: infraclavicular blockThe transducer is positioned in the parasagittal plane to identify the axillary artery. Surrounding the artery are the three cords of the brachial plexus: the lateral, posterior, and medial cords. The needle is inserted in-plane short-axis technique from the cephalad end of the probe, with the insertion point just inferior to the clavicle. A local anesthetic will be injected posterior to the axillary artery to achieve a U-shaped distribution around the artery (cephalad, caudad, and posterior). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Gender both males and females
- ASA Class I, II
- Age 18-60 years
- Patients undergoing minor hand surgery (skin graft, Carpal Tunnel Release, ganglion removal, and lipoma ) expected surgical time of more than 15 min and less than one hour.
Key exclusion criteria (4 listed)
- Allergy to local anesthetic
- Infection of the skin at the site of block.
- Bilateral surgery, neck and clavicle deformities, existing neurological disease chronic pain diagnosis, pre-existing nerve damage, muscle injuries, and tendon injury.
- Coagulopathy, previous surgery on the operative limb, inability to comprehend study-related procedures, and clinically significant cognitive impairment.
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 |
|---|---|---|
| axillary blockAlso: peripheral nerve blockit will be given using 20 ml of drug 0.25% bupivacaine (10 ml 0.5% bupivacaine + 10 ml normal saline). | Procedure or surgery | Ultrasound guided axillary block |
| infraclavicular blockAlso: peripheral nerve blockit will be given using 20 ml of drug 0.25% bupivacaine (10 ml 0.5% bupivacaine + 10 ml normal saline). | Procedure or surgery | Ultrasound guided infraclavicular block block |
Primary outcome
Postoperative change in handgrip strength in the operative limb
Time frame: it will be measured at 90 min from the block
Postoperative change in handgrip strength in the operative limb as a percent reduction of preoperative baseline strength at 90 min from the block (%)
1 secondary outcome
Block related complications
Time frame: it will be measured in the first 24 hours postoperative
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 28 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Hand Surgery
Not yet recruitingPhase 4
Bicarbonate Addition to Lidocaine-Epinephrine in Surgery Under WALANT
Anesthesia, Local, Hand Surgery
Recruiting
Comparison of Conventional and Retroclavicular Approaches for Ultrasound-guided Infraclavicular Brachial Plexus Block
Peripheral Nerve Block, Pain Management
Recruiting
Evaluating the Benefit of Hypnoanalgesia Versus Neuroleptanalgesia During Hand Surgery
Hand Surgery
Active, not recruitingPhase 2/3
Wide-Awake Local Anesthesia No Tourniquet (WALANT) With Versus Without Hyaluronidase for Hand Surgery
Hand Surgery, Local Infiltration
Not yet recruiting
Efficacy of Laser Acupuncture on Carpal Tunnel Syndrome Following Hand Flexor Tendon Repair
Laser Acupuncture, Flexor Tendon Repair
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.
Yasser EL Halafawy, professor study director
Anesthesia department , Cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing axillary block and infraclavicular block in people with Hand Surgery and Ultrasound Guided, run by Kasr El Aini Hospital at 1 site in Egypt.
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 4 inclusion and 4 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 28 Apr 2023. 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 Egypt. 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 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?
Postoperative change in handgrip strength in the operative limb (time frame: it will be measured at 90 min from the block). 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 28 Apr 2023; AzTrials last refreshed its copy on 1 Nov 2026.