AnesthesiaNCT01761175
Comparison of Ultrasound-Guided Infraclavicular Block and Ultrasound-Guided Axillary Block
A study testing Ultrasound-guided infraclavicular block and Ultrasound-guided axillary block in people with Anesthesia, run by CHU de Quebec-Universite Laval at 2 sites in Canada.
Trial summary
The purpose of this study is to compare the rate of complete sensory block at 30 minutes following ultrasound-guided single injection infraclavicular block and ultrasound-guided double injection axillary block. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- Ultrasound-guided infraclavicular block and Ultrasound-guided axillary block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 2 sitesCanada
- Study dates
- Sep 2012to Mar 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- American Society of Anesthesiologists Class 1 to 3
- Undergoing a surgery at the elbow, forearm, wrist or hand under regional anesthesia
Who cannot join
- Age less than 18 years
- Body mass index more than 40 kg/m2
- Weight less than 45 kg
- Patient refusal
- Contraindication to regional anesthesia (coagulopathy, local infection at the puncture site, systemic infection)
- Previous neurological deficit in the operated arm
Show all 9Show fewer
- Severe renal or hepatic failure
- Prior surgery in the axillary or infraclavicular area
- Pregnancy or breast-feeding
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Hôpital de l'Enfant-Jésus
Québec, G1J 1Z4
Hôpital de Saint-Sacrement
Québec, G1S 4L8
About this study
Official title: Comparison of Ultrasound-Guided Single Injection Infraclavicular Block or Ultrasound-Guided Double Injection Axillary Block : A Non-inferiority Randomized Trial
The purpose of this study is to compare the rate of complete sensory block at 30 minutes following ultrasound-guided single injection infraclavicular block and ultrasound-guided double injection axillary block. The investigators research hypothesis is that both blocks will show comparable rates of complete sensory block at 30 minutes.
- Conditions
- Anesthesia
- Being tested
- Ultrasound-guided infraclavicular block, Ultrasound-guided axillary block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided infraclavicular blockProcedure or surgery
Ultrasound-guided single injection infraclavicular block: using an in-plane technique, 30 mL of mepivacaine 1.5% is injected at the posterior aspect of the artery.
Ultrasound-guided axillary blockProcedure or surgery
Ultrasound-guided double injection axillary block: using an in-plane technique, 25 mL of mepivacaine 1.5% is injected postero-medial to the artery. During needle withdrawal, 5 mL of the same solution is injected close to the musculocutaneous nerve.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-guided infraclavicular block | Active comparator | Ultrasound-guided single injection infraclavicular block Receives: Procedure: Ultrasound-guided infraclavicular block |
| Ultrasound-guided axillary block | Active comparator | Ultrasound-guided double injection axillary block Receives: Procedure: Ultrasound-guided axillary block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Complete Sensory Block
Complete sensory block is defined by anesthesia to cold sensation in the ulnar, radial, median and musculocutaneous nerves territories.
Measured: 30 minutes after block completion
Secondary outcomes (11)
Number of Patients With Complete Motor Blocks
Complete motor block is defined by paralysis in the ulnar, radial, median and musculocutaneous nerves territories.
Measured: 30 minutes after block completion
Time to Complete Sensory Block.
Complete sensory block is defined by anesthesia to cold sensation in the median, ulnar, radial and musculocutaneous nerves territories.
Measured: 5, 10, 15, 20, 25 and 30 minutes after block completion
Time to Complete Motor Block
Complete motor block is defined by paralysis in the median, ulnar, radial and musculocutaneous nerves territories.
Measured: 5, 10, 15, 20, 25 and 30 minutes after block completion
Surgical Block Success Rate
Surgical block success is defined by a nerve block allowing surgery without a rescue block, an infiltration of local anesthetics by the surgeon, administration of analgesics for pain in the surgical field or a general anesthesia.
Measured: End of surgery
Performance Time of the Nerve Block
Performance time is defined as the sum of imaging time (defined as the time elapsed from the moment the Doppler probe is in contact with the patient to the insertion of the Tuohy needle) and needling time (from the insertion of the needle to its complete removal).
Measured: During the performance of the block
Procedure-related Pain on a Visual Analog Pain Scale
Pain was evaluated by the patient on a visual analog pain scale ranging from 0 (no pain) to 10 (worst pain of their life).
Measured: After the nerve block procedure ended, up to 5 minutes.
Number of Patients With Postoperative Adverse Events Related to Nerve Block
Adverse events were defined by residual numbness, loss of sensitivity or weakness in the operated arm related to block performance or signs of hematoma or infection at the puncture site.
Measured: 24 hours after surgery
Number of Patients With Postoperative Adverse Events Related to Nerve Block
Adverse events were defined by residual numbness, loss of sensitivity or weakness in the operated arm related to block performance or signs of hematoma or infection at the puncture site.
Measured: 1 month after surgery
Duration of Surgery
Measured: The end of surgery
Tourniquet Use
Number of participants who had a tourniquet during the surgery
Measured: The end of surgery
Duration of Tourniquet
The total time the tourniquet was left inflated
Measured: The end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2013 (estimated)
- Study startSep 2012
- Primary completionFeb 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ariane Boivin, CHU de Quebec-Universite Laval
- Investigators
- Ariane Boivin, MD, Principal investigator, CHU de QuébecMarie-Josée Nadeau, MD, Principal investigator, CHU de QuébecNicolas Dion, MD, Principal investigator, CHU de QuébecSimon Lévesque, MD, Principal investigator, CHU de QuébecPierre C. Nicole, MD, Principal investigator, CHU de QuébecAlexis F. Turgeon, MD, Msc, Principal investigator, CHU de Québec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01761175
- Sponsor's protocol ID
- PEJ-666
- Status last verified
- Apr 2017
- First submitted
- 3 Jan 2013
- Last updated
- 4 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Boivin A, Nadeau MJ, Dion N, Levesque S, Nicole PC, Turgeon AF. Ultrasound-Guided Single-Injection Infraclavicular Block Versus Ultrasound-Guided Double-Injection Axillary Block: A Noninferiority Randomized Controlled Trial. Anesth Analg. 2016 Jan;122(1):273-8. doi: 10.1213/ANE.0000000000001017.
PubMed 26516803
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound-Guided Single Injection Infraclavicular Block or Ultrasound-Guided Double Injection Axillary Block : A Non-inferiority Randomized Trial
- ClinicalTrials.gov ID
- NCT01761175
- Acronym / sponsor ID
- PEJ-666
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 4 Jan 2013 (estimated)
- Results
- Posted 4 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the rate of complete sensory block at 30 minutes following ultrasound-guided single injection infraclavicular block and ultrasound-guided double injection axillary block. The investigators research hypothesis is that both blocks will show comparable rates of complete sensory block at 30 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-guided infraclavicular block | Active comparator | Procedure: Ultrasound-guided infraclavicular blockUltrasound-guided single injection infraclavicular block |
| Ultrasound-guided axillary block | Active comparator | Procedure: Ultrasound-guided axillary blockUltrasound-guided double injection axillary block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- American Society of Anesthesiologists Class 1 to 3
- Undergoing a surgery at the elbow, forearm, wrist or hand under regional anesthesia
Key exclusion criteria (9 listed)
- Age less than 18 years
- Body mass index more than 40 kg/m2
- Weight less than 45 kg
- Patient refusal
- Contraindication to regional anesthesia (coagulopathy, local infection at the puncture site, systemic infection)
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 |
|---|---|---|
| Ultrasound-guided infraclavicular blockUltrasound-guided single injection infraclavicular block: using an in-plane technique, 30 mL of mepivacaine 1.5% is injected at the posterior aspect of the artery. | Procedure or surgery | Ultrasound-guided infraclavicular block |
| Ultrasound-guided axillary blockUltrasound-guided double injection axillary block: using an in-plane technique, 25 mL of mepivacaine 1.5% is injected postero-medial to the artery. During needle withdrawal, 5 mL of the same solution is injected close to the musculocutaneous nerve. | Procedure or surgery | Ultrasound-guided axillary block |
Primary outcome
Number of Patients With Complete Sensory Block
Time frame: 30 minutes after block completion
Complete sensory block is defined by anesthesia to cold sensation in the ulnar, radial, median and musculocutaneous nerves territories.
11 secondary outcomes
Number of Patients With Complete Motor Blocks
Time frame: 30 minutes after block completion
Time to Complete Sensory Block.
Time frame: 5, 10, 15, 20, 25 and 30 minutes after block completion
Time to Complete Motor Block
Time frame: 5, 10, 15, 20, 25 and 30 minutes after block completion
Surgical Block Success Rate
Time frame: End of surgery
Performance Time of the Nerve Block
Time frame: During the performance of the block
Procedure-related Pain on a Visual Analog Pain Scale
Time frame: After the nerve block procedure ended, up to 5 minutes.
Number of Patients With Postoperative Adverse Events Related to Nerve Block
Time frame: 24 hours after surgery
Number of Patients With Postoperative Adverse Events Related to Nerve Block
Time frame: 1 month after surgery
Duration of Surgery
Time frame: The end of surgery
Tourniquet Use
Time frame: The end of surgery
Duration of Tourniquet
Time frame: The end of surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26516803Boivin A, Nadeau MJ, Dion N, Levesque S, Nicole PC, Turgeon AF. Ultrasound-Guided Single-Injection Infraclavicular Block Versus Ultrasound-Guided Double-Injection Axillary Block: A Noninferiority Randomized Controlled Trial. Anesth Analg. 2016 Jan;122(1):273-8. doi: 10.1213/ANE.0000000000001017.
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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.
Ariane Boivin, MD principal investigator
CHU de Québec
Marie-Josée Nadeau, MD principal investigator
CHU de Québec
Nicolas Dion, MD principal investigator
CHU de Québec
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided infraclavicular block and Ultrasound-guided axillary block in people with Anesthesia, run by CHU de Quebec-Universite Laval at 2 sites 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 3 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 4 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 4 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients With Complete Sensory Block (time frame: 30 minutes after block completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01761175, which also lists 1 linked publication.
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 4 Aug 2017; AzTrials last refreshed its copy on 8 Nov 2026.