Hand SurgeryNCT00827658
Ulnar Nerve Block for Procedural Anesthesia - Wrist Versus Palm
A study testing Volar Wrist Block and Hypothenar Palm block in people with Hand Surgery, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
Ulnar nerve blockade is necessary for sensory anesthesia and analgesia in the hand during minor procedures. The course of the ulnar nerve in the forearm, wrist, and hand is predictable and has low variability. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hand Surgery
- What is being tested?
- Volar Wrist Block and Hypothenar Palm block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2008to Jul 2009
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- any individual who can give informed consent and is scheduled for elective hand procedures by the PI necessitating an Ulnar nerve block of the hand.
Who cannot join
- patients unable to give informed consent
- patients with previous or ongoing ulnar nerve deficits or neuropathy
- patients undergoing Guyon's canal decompression
- patients who can not comprehend or cooperate with assessment testing
- patients with abnormal two point discrimination (> 6 mm at the test location) prior to the nerve block
Trial locations and contacts
1 site in 1 country.
About this study
Ulnar nerve blockade is necessary for sensory anesthesia and analgesia in the hand during minor procedures. The course of the ulnar nerve in the forearm, wrist, and hand is predictable and has low variability. However even with known anatomic location and landmarks, ulnar nerve blocks at the wrist frequently are inadequate for procedural anesthesia. The antebrachial fascia at the wrist acts as a barrier to local infiltration. Since the fascia can not be visualized or palpated, it is commonly not penetrated, resulting in an inadequate block. Furthermore at the level of the wrist the ulnar artery lies in close proximity to the nerve and there is potential for arterial puncture while attempting injection for volar wrist block. The palmar ulnar nerve block is an injection distal to the hook of the hamate in the thenar eminence which avoids the ulnar artery and antebrachial fascia. This block has been used successfully for many years in clinical practice but has not been assessed or compared in a research study. The purpose of this study is to assess the validity of using a palmar ulnar nerve block for procedures in the hand as compared to the standard volar wrist ulnar nerve block.
- Conditions
- Hand Surgery
- Being tested
- Volar Wrist Block, Hypothenar Palm block
- Keywords
- anesthesia, local, ulnar nerve, hand, surgery, plastic, blinded, randomized, prospective, local anesthesia, volar wrist block, hypothenar palm block, hand surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volar Wrist BlockProcedure or surgery
Injection medial to Flexor Carpi Ulnaris Tendon at volar proximal wrist crease
Local Block - total 3 cc injection (1.5 cc 1% plain lidocaine and 1.5 cc of 0.25% bupivicaine)
Hypothenar Palm blockProcedure or surgery
Injection at Hook of the Hamate on Palmar surface
Local Block - total 3 cc injection (1.5 cc 1% plain lidocaine and 1.5 cc of 0.25% bupivicaine)
| Study group | Role | What they receive |
|---|---|---|
| Hypothenar Palm block | Active comparator | Hypothenar Palmar block group. Local anesthetic is placed at this location in this study group. The same local composition (Intervention) is used for both study groups. The trial is a comparison of location not the Intervention. Receives: Procedure: Hypothenar Palm block |
| Volar Wrist Block | Active comparator | Volar Wrist block group. Local anesthetic is placed at this location in this study group. The same local composition (Intervention) is used for both study groups. The trial is a comparison of location not the Intervention. Receives: Procedure: Volar Wrist Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome is efficacy of sensory anesthesia and analgesia
Measured: 15-45 minutes
Secondary outcomes (1)
Secondary outcome is patient perceived discomfort with block
Measured: 15-45 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2009 (estimated)
- Study startFeb 2008
- Primary completionJul 2009
- Study completionJul 2009
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University
- Responsible party
- Sponsor
- Investigators
- Stuart Martin, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00827658
- Sponsor's protocol ID
- McMaster 08-053
- Status last verified
- May 2018
- First submitted
- 21 Jan 2009
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ulnar Nerve Block for Procedural Anesthesia - Wrist Versus Palm
- ClinicalTrials.gov ID
- NCT00827658
- Acronym / sponsor ID
- McMaster 08-053
- Conditions
- Hand Surgery
- Keywords
- anesthesia, local, ulnar nerve, hand, surgery, plastic, blinded, randomized, prospective, local anesthesia
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- McMaster University
- Study start
- Feb 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 23 Jan 2009 (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.
Ulnar nerve blockade is necessary for sensory anesthesia and analgesia in the hand during minor procedures. The course of the ulnar nerve in the forearm, wrist, and hand is predictable and has low variability. However even with known anatomic location and landmarks, ulnar nerve blocks at the wrist frequently are inadequate for procedural anesthesia. The antebrachial fascia at the wrist acts as a barrier to local infiltration. Since the fascia can not be visualized or palpated, it is commonly not penetrated, resulting in an inadequate block. Furthermore at the level of the wrist the ulnar artery lies in close proximity to the nerve and there is potential for arterial puncture while attempting injection for volar wrist block. The palmar ulnar nerve block is an injection distal to the hook of the hamate in the thenar eminence which avoids the ulnar artery and antebrachial fascia. This block has been used successfully for many years in clinical practice but has not been assessed or compared in a research study. The purpose of this study is to assess the validity of using a palmar ulnar nerve block for procedures in the hand as compared to the standard volar wrist ulnar nerve block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypothenar Palm block | Active comparator | Procedure: Hypothenar Palm blockHypothenar Palmar block group. Local anesthetic is placed at this location in this study group. The same local composition (Intervention) is used for both study groups. The trial is a comparison of location not the Intervention. |
| Volar Wrist Block | Active comparator | Procedure: Volar Wrist BlockVolar Wrist block group. Local anesthetic is placed at this location in this study group. The same local composition (Intervention) is used for both study groups. The trial is a comparison of location not the Intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- any individual who can give informed consent and is scheduled for elective hand procedures by the PI necessitating an Ulnar nerve block of the hand.
Key exclusion criteria (5 listed)
- patients unable to give informed consent
- patients with previous or ongoing ulnar nerve deficits or neuropathy
- patients undergoing Guyon's canal decompression
- patients who can not comprehend or cooperate with assessment testing
- patients with abnormal two point discrimination (> 6 mm at the test location) prior to the nerve block
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 |
|---|---|---|
| Volar Wrist BlockInjection medial to Flexor Carpi Ulnaris Tendon at volar proximal wrist crease Local Block - total 3 cc injection (1.5 cc 1% plain lidocaine and 1.5 cc of 0.25% bupivicaine) | Procedure or surgery | Volar Wrist Block |
| Hypothenar Palm blockInjection at Hook of the Hamate on Palmar surface Local Block - total 3 cc injection (1.5 cc 1% plain lidocaine and 1.5 cc of 0.25% bupivicaine) | Procedure or surgery | Hypothenar Palm block |
Primary outcome
Primary outcome is efficacy of sensory anesthesia and analgesia
Time frame: 15-45 minutes
1 secondary outcome
Secondary outcome is patient perceived discomfort with block
Time frame: 15-45 Minutes
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
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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.
Stuart Martin principal investigator
McMaster 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 Volar Wrist Block and Hypothenar Palm block in people with Hand Surgery, run by Hamilton Health Sciences Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 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: stopped early, as of the sponsor's last update on 14 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Primary outcome is efficacy of sensory anesthesia and analgesia (time frame: 15-45 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 14 May 2018.