Carpal Tunnel SyndromePhase 4NCT03649763
Onset and Duration of Forearm Nerve Blockade
A Phase 4 study testing Lidocaine and Bupivacaine in people with Carpal Tunnel Syndrome, run by New York School of Regional Anesthesia at 1 site in Belgium.
Trial summary
This pilot study will evaluate the latency of onset and duration of sensory-motor block in patients undergoing hand surgery. Patients will be randomized to receive nerve blocks of the distal forearm or of the distal and proximal forearm. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Lidocaine and Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBelgium
- Study dates
- 7 Mar 2018to 31 Dec 2018
- Phase
- Phase 4
- 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
- Scheduled to undergo daycare surgery for carpal tunnel syndrome under peripheral nerve blocks
- American Society of Anesthesiologists (ASA) physical status I, II or III
- Able to demonstrate sensory function in the ulnar and median nerve distribution by exhibiting sensitivity to cold, pinprick and light touch
- Scheduled to undergo primary hand surgery
- Able to understand the Dutch language, purpose and risks of the study
- Able to provide informed consent and authorization to use protected health information, adhere to the study visit schedule, and complete all study assessments
Who cannot join
- Currently pregnant or nursing
- History of hypersensitivity to local anesthetics
- Contraindication to lidocaine, bupivacaine, paracetamol
- Medical condition that will make it difficult to assess sensory distributions of the upper extremity peripheral nerves or to communicate with staff
- Suspected or known recent history (< 3 months) of drug or alcohol abuse
- Concurrent physical condition that may require analgesic treatment (such as NSAID or opioid) in the postsurgical period for pain that is not strictly related to Carpal Tunnel Syndrome and which may confound the postsurgical assessments
Show all 14Show fewer
- Infection at the planned block site(s)
- Initiation of treatment with any of the following medications within 1 month of study drug administration or if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin (Lyrica®), or duloxetine (Cymbalta®)
- Body weight <40 kg or body mass index >44 kg/m2
- Uncontrolled anxiety, psychiatric, or neurological disorder that might interfere with study assessments
- Any chronic neuromuscular deficit affecting the Ulnar and Median nerves or muscles of the surgical extremity
- Any chronic condition or disease that would compromise neurological
- Presence of pre-existing coagulation disorders
- Baseline neurological deficits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Onset and Duration of Forearm Nerve Blockade Performed With a Single Distal Injection Versus Sequential Injections at Distal and Proximal Locations Alongside the Nerves: A Blinded Randomized
This pilot study will evaluate the latency of onset and duration of sensory-motor block in patients undergoing hand surgery. Patients will be randomized to receive nerve blocks of the distal forearm or of the distal and proximal forearm. Local anesthetic will be injected to anesthetise the median and ulnar nerves in the distal forearm (1-injection site group) or the median and ulnar nerves in the distal and proximal forearm (2-sequential injection sites group) to accomplish anesthesia for surgery on the hand.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Lidocaine, Bupivacaine
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
lidocaine 1%, distal ( ulnar and medial nerve): 6ml/nerve , 12m total
BupivacaineDrug
Bupivacaine 0.5%,distal ( ulnar and medial nerve): 6ml/nerve , 12m total
LidocaineDrug
lidocaine 1%, distal and proximal ( ulnar and medial nerve): 3ml/nerve , 12m total
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine distal forearm | Active comparator | Lidocaine 1% - Ultrasound-guided specific blocks of the DISTAL median and ulnar nerves with perineural injections of Lidocaine1%. Volume injected is 6 mL/nerve; 12 mL total. Receives: Drug: Lidocaine |
| Bupivacaine distal forearm | Active comparator | Bupivacaine 0.5%-Ultrasound-guided specific blocks of the DISTAL median and ulnar nerves with perineural injections of Bupivacaine0.5%. Volume injected is 6 mL/nerve; 12 mL total. Receives: Drug: Bupivacaine |
| Lidocaine distal and proximal forearm | Active comparator | Lidocaine 1%- Ultrasound-guided specific blocks of the DISTAL and PROXIMAL median and ulnar nerves with perineural injections of Lidocaine 1%. Volume injected is 3 mL/nerve; 12 mL total Receives: Drug: Lidocaine |
| Bupivacaine distal and proximal forearm | Active comparator | Bupivacaine 0.5%- Ultrasound-guided specific blocks of the DISTAL and PROXIMAL median and ulnar nerves with perineural injections of Bupivacaine 0.5 %. Volume injected is 3 mL/nerve; 12 mL total. Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves. Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch.
Measured: 5-minute beginning at the end of the last injection
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves. Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch.
Measured: 10-minute beginning at the end of the last injection
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves. Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch.
Measured: 15-minute beginning at the end of the last injection
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves. Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch.
Measured: 20-minute beginning at the end of the last injection
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves. Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch.
Measured: 25-minute beginning at the end of the last injection
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves. Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch.
Measured: 30-minute beginning at the end of the last injection
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves. Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch.
Measured: 45-minute beginning at the end of the last injection
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves. Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch.
Measured: 60-minute beginning at the end of the last injection
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves. Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch.
Measured: Post Anesthesia Care Unit arrival
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves. Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch.
Measured: 15-minute after Post Anesthesia Care Unit arrival
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves. Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch.
Measured: 30-minute after Post Anesthesia Care Unit arrival
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves. Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch.
Measured: Post Anesthesia Care Unit discharge
Secondary outcomes (15)
postoperative Numeric Rating Scale (NRS)
pain rating(numeric rating scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
Measured: screening Day0 (prior to the nerve block), post block, PACU arrival, Day0 evening, Day1 morning and evening, Day2 morning and evening, Day3 morning and evening, Day4, Day5, Day6, Day7
postoperative Numeric Rating Scale (NRS)
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
Measured: post block
postoperative Numeric Rating Scale (NRS)
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
Measured: Post Anesthesia Care Unit arrival
postoperative Numeric Rating Scale (NRS)
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
Measured: Day 0 evening
postoperative Numeric Rating Scale (NRS)
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
Measured: Day 1 morning
postoperative Numeric Rating Scale (NRS)
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
Measured: Day 1 evening
postoperative Numeric Rating Scale (NRS)
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
Measured: Day 2 morning
postoperative Numeric Rating Scale (NRS)
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
Measured: Day 2 evening
postoperative Numeric Rating Scale (NRS)
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
Measured: Day 3 morning
postoperative Numeric Rating Scale (NRS)
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
Measured: Day 3 evening
postoperative Numeric Rating Scale (NRS)
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
Measured: Day 4
postoperative Numeric Rating Scale (NRS)
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
Measured: Day 5
postoperative Numeric Rating Scale (NRS)
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
Measured: Day 6
postoperative Numeric Rating Scale (NRS)
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
Measured: Day 7
postoperative Numeric Rating Scale (NRS)
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start7 Mar 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York School of Regional Anesthesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catherine Vandepitte, M.D., New York School of Regional Anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03649763
- Sponsor's protocol ID
- 1801
- Status last verified
- Feb 2019
- First submitted
- 1 Aug 2018
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Onset and Duration of Forearm Nerve Blockade Performed With a Single Distal Injection Versus Sequential Injections at Distal and Proximal Locations Alongside the Nerves: A Blinded Randomized
- ClinicalTrials.gov ID
- NCT03649763
- Acronym / sponsor ID
- 1801
- Conditions
- Carpal Tunnel Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- New York School of Regional AnesthesiaUniversity, hospital or other
- Study start
- 7 Mar 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 28 Aug 2018 (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.
This pilot study will evaluate the latency of onset and duration of sensory-motor block in patients undergoing hand surgery. Patients will be randomized to receive nerve blocks of the distal forearm or of the distal and proximal forearm. Local anesthetic will be injected to anesthetise the median and ulnar nerves in the distal forearm (1-injection site group) or the median and ulnar nerves in the distal and proximal forearm (2-sequential injection sites group) to accomplish anesthesia for surgery on the hand.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lidocaine distal forearm | Active comparator | Drug: LidocaineLidocaine 1% - Ultrasound-guided specific blocks of the DISTAL median and ulnar nerves with perineural injections of Lidocaine1%. Volume injected is 6 mL/nerve; 12 mL total. |
| Bupivacaine distal forearm | Active comparator | Drug: BupivacaineBupivacaine 0.5%-Ultrasound-guided specific blocks of the DISTAL median and ulnar nerves with perineural injections of Bupivacaine0.5%. Volume injected is 6 mL/nerve; 12 mL total. |
| Lidocaine distal and proximal forearm | Active comparator | Drug: LidocaineLidocaine 1%- Ultrasound-guided specific blocks of the DISTAL and PROXIMAL median and ulnar nerves with perineural injections of Lidocaine 1%. Volume injected is 3 mL/nerve; 12 mL total |
| Bupivacaine distal and proximal forearm | Active comparator | Drug: BupivacaineBupivacaine 0.5%- Ultrasound-guided specific blocks of the DISTAL and PROXIMAL median and ulnar nerves with perineural injections of Bupivacaine 0.5 %. Volume injected is 3 mL/nerve; 12 mL total. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Scheduled to undergo daycare surgery for carpal tunnel syndrome under peripheral nerve blocks
- American Society of Anesthesiologists (ASA) physical status I, II or III
- Able to demonstrate sensory function in the ulnar and median nerve distribution by exhibiting sensitivity to cold, pinprick and light touch
- Scheduled to undergo primary hand surgery
- Able to understand the Dutch language, purpose and risks of the study
Key exclusion criteria (14 listed)
- Currently pregnant or nursing
- History of hypersensitivity to local anesthetics
- Contraindication to lidocaine, bupivacaine, paracetamol
- Medical condition that will make it difficult to assess sensory distributions of the upper extremity peripheral nerves or to communicate with staff
- Suspected or known recent history (< 3 months) of drug or alcohol abuse
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 |
|---|---|---|
| Lidocainelidocaine 1%, distal ( ulnar and medial nerve): 6ml/nerve , 12m total | Drug | Lidocaine distal forearm |
| BupivacaineBupivacaine 0.5%,distal ( ulnar and medial nerve): 6ml/nerve , 12m total | Drug | Bupivacaine distal and proximal forearm, Bupivacaine distal forearm |
| Lidocainelidocaine 1%, distal and proximal ( ulnar and medial nerve): 3ml/nerve , 12m total | Drug | Lidocaine distal and proximal forearm |
Primary outcome
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Time frame: 5-minute beginning at the end of the last injection
Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves. Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch.
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Time frame: 10-minute beginning at the end of the last injection
Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves. Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch.
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Time frame: 15-minute beginning at the end of the last injection
Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves. Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch.
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Time frame: 20-minute beginning at the end of the last injection
Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves. Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch.
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Time frame: 25-minute beginning at the end of the last injection
Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves. Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch.
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Time frame: 30-minute beginning at the end of the last injection
Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves. Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch.
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Time frame: 45-minute beginning at the end of the last injection
Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves. Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch.
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Time frame: 60-minute beginning at the end of the last injection
Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves. Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch.
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Time frame: Post Anesthesia Care Unit arrival
Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves. Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch.
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Time frame: 15-minute after Post Anesthesia Care Unit arrival
Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves. Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch.
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Time frame: 30-minute after Post Anesthesia Care Unit arrival
Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves. Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch.
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Time frame: Post Anesthesia Care Unit discharge
Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves. Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch.
15 secondary outcomes
postoperative Numeric Rating Scale (NRS)
Time frame: screening Day0 (prior to the nerve block), post block, PACU arrival, Day0 evening, Day1 morning and evening, Day2 morning and evening, Day3 morning and evening, Day4, Day5, Day6, Day7
postoperative Numeric Rating Scale (NRS)
Time frame: post block
postoperative Numeric Rating Scale (NRS)
Time frame: Post Anesthesia Care Unit arrival
postoperative Numeric Rating Scale (NRS)
Time frame: Day 0 evening
postoperative Numeric Rating Scale (NRS)
Time frame: Day 1 morning
postoperative Numeric Rating Scale (NRS)
Time frame: Day 1 evening
postoperative Numeric Rating Scale (NRS)
Time frame: Day 2 morning
postoperative Numeric Rating Scale (NRS)
Time frame: Day 2 evening
postoperative Numeric Rating Scale (NRS)
Time frame: Day 3 morning
postoperative Numeric Rating Scale (NRS)
Time frame: Day 3 evening
postoperative Numeric Rating Scale (NRS)
Time frame: Day 4
postoperative Numeric Rating Scale (NRS)
Time frame: Day 5
postoperative Numeric Rating Scale (NRS)
Time frame: Day 6
postoperative Numeric Rating Scale (NRS)
Time frame: Day 7
postoperative Numeric Rating Scale (NRS)
Time frame: Day 30
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 26 Feb 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine and Bupivacaine in people with Carpal Tunnel Syndrome, run by New York School of Regional Anesthesia at 1 site in Belgium.
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 6 inclusion and 14 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 26 Feb 2019. 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 Belgium. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves (time frame: 5-minute beginning at the end of the last injection). The study lists 12 primary outcomes in all. 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 26 Feb 2019.