Anesthesia, RegionalICAXNCT04053491
Comparison of the Infraclavicular and Axillary Approaches for Continuous Ultrasound-guided Brachial Plexus Block.
A study testing Hand surgery under regional anesthesia in people with Anesthesia, Regional and Brachial Plexus Block, run by University Hospital, Bordeaux.
Trial summary
Prospective randomized study comparing the axillary and the infraclavicular approaches for continuous brachial plexus block after hand surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Regional, Brachial Plexus Block
- What is being tested?
- Hand surgery under regional anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2019to Oct 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with a social insurance number
- ASA 1-3
- Patients undergoing hand surgery requiring a continuous brachial plexus block
- Elective or urgent surgery
- Effective contraception (HAS criteria)
- Informed consent
Who cannot join
- Contraindication to the installation of a continuous brachial plexus block (coagulopathy, refusal, allergy to the medication)
- Preexisting neuropathy
- Pregnancy
- Arteriovenous fistula
- Obesity (BMI >40)
- Another surgical site implicated during the surgery
- Incapacity to abduct the operated arm
- Preoperative use of morphine or equivalent
About this study
Official title: Comparison of the Infraclavicular and Axillary Approaches for Continuous Ultrasound-guided Brachial Plexus Block: A Prospective Randomized Study
Prospective randomized study comparing the axillary and the infraclavicular approaches for continuous brachial plexus block after hand surgery.
Read the detailed description
Regional anesthesia is considered as the gold standard for analgesia and anesthesia of hand surgeries. However, with a single-shot technique, a maximum of 13 hours of analgesia is obtained, even with a long-acting local anesthetic and adjuvants. For painful surgeries necessitating prolonged analgesia of more than 24 hours, continuous regional analgesia techniques have been described, using perinervous catheters. However, these techniques have a high incidence of failure. The most frequent causes of failure are catheter displacements, misplacement, and the distance between the targeted nerves. Many approaches have been described to insert these catheters (axillary, infraclavicular and supraclavicular), but the optimal approach remains unknown. Therefore, international and even local practices vary widely.
Investigators plan to compare the axillary and the infraclavicular approaches in this randomized study, on 60 patients. In every group, an initial bolus will be given and then a perinervous catheter will be inserted by the allocated approach. The surgery will be done under regional anesthesia. The co-analgesia, the local anesthetic infusion and the follow-up will be standardized and will be the same in the two groups.
The primary outcome will be an anesthesia score on 16 points previously described in other similar publication. The primary outcome will be at 24 hours after block realization, but it will be repeated at 48 hours. It will evaluate the degree of sensitive and motor blockade of every major nerve of the hand. Secondary outcomes will be the time, comfort and adverse effects of the technique, and postoperative pain, analgesia, satisfaction and adverse effects.
The aim of this study is to help determine the optimal approach for brachial plexus catheter insertion, in order to improve analgesia, to decrease morphine consumption and its related adverse effects, and to improve patients and caregivers satisfaction.
- Conditions
- Anesthesia, Regional, Brachial Plexus Block
- Being tested
- Hand surgery under regional anesthesia
- Keywords
- Hand surgery, Anesthesia, Regional, Brachial Plexus Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand surgery under regional anesthesiaProcedure or surgery
In both groups, patients will benefit from an initial standardized bolus (long-acting local anesthetic, ropivacaine) to cover the operative period, via the allocated approach. Ultrasound guidance and the recommended standards monitors will be used in both groups. After the initial bolus, a catheter will be inserted via the allocated approach. Surgery will be done under regional anesthesia alone, unless there is a medical contraindication or if the patient asks for general anesthesia. Post-operative analgesia will be standardized with regular paracetamol, regular NSAID (Nonsteroidal anti-inflammatory drugs) and oxycodone if needed. The local anesthetics perfusion will be standardized. There will be a medical follow up at 24 and 48 hours where data will be collected.
| Study group | Role | What they receive |
|---|---|---|
| Axillary block group | Experimental | Initial bolus will be given and then a perinervous catheter will be inserted by the axillary approach. Receives: Procedure: Hand surgery under regional anesthesia |
| Infraclavicular block group | Experimental | Initial bolus will be given and then a perinervous catheter will be inserted by the infraclavicular approach. Receives: Procedure: Hand surgery under regional anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anesthesia score
Min/Max : 0 for no anesthesia to 16 total anesthesia Addition of Motor block score (0-2) and Sensitive block score (0-2) for the 4 main nerves of the hand
Measured: 24 hours after block realization
Secondary outcomes (9)
Duration of catheter insertion procedure
Measured: During block realization
Maximal pain during the surgery procedure
Measured by patient with numeric scale from 0 = no pain to 10 = maximal pain
Measured: During surgery
Maximal pain during the first 24 hours
Measured by patient with numeric scale from 0 = no pain to 10 = maximal pain
Measured: During the first 24 hours after block realization
Anesthesia score
Min/Max : 0 for no anesthesia to 16 total anesthesia Addition of Motor block score (0-2) and Sensitive block score (0-2) for the 4 main nerves of the hand
Measured: 30 minutes after block realization
Anesthesia score
Min/Max : 0 for no anesthesia to 16 total anesthesia Addition of Motor block score (0-2) and Sensitive block score (0-2) for the 4 main nerves of the hand
Measured: 48 hours after block realization
Total morphine consumption
Measured: 24 and 48 hours after block realization
Mean pain at rest and with movement
Measured by patient with numeric scale from 0 = no pain to 10 = maximal pain
Measured: 24 and 48 hours after block realization
Quality of sleep
Measured by patient with numeric scale from 0 = insomnia to 10 = excellent sleep
Measured: Over first night after block realization
Patient satisfaction
Measured by patient with numeric scale from 0 = fully unsatisfied to 10 = fully satisfied
Measured: 48 hours after block realization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study startSep 2019 (estimated)
- Primary completionOct 2020 (estimated)
- Study completionOct 2020 (estimated)
Why it stopped: funding not obtained
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, RegionalStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04053491
- Sponsor's protocol ID
- CHUBX 2019/04
- Acronym
- ICAX
- Status last verified
- Mar 2023
- First submitted
- 7 Aug 2019
- Last updated
- 17 Mar 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 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Infraclavicular and Axillary Approaches for Continuous Ultrasound-guided Brachial Plexus Block: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT04053491
- Acronym / sponsor ID
- ICAX / CHUBX 2019/04
- Conditions
- Anesthesia, Regional, Brachial Plexus Block
- Keywords
- Hand surgery, Anesthesia, Regional, Brachial Plexus Block
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: funding not obtained
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Sep 2019 (estimated)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 12 Aug 2019 (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.
Prospective randomized study comparing the axillary and the infraclavicular approaches for continuous brachial plexus block after hand surgery.
Detailed description
Regional anesthesia is considered as the gold standard for analgesia and anesthesia of hand surgeries. However, with a single-shot technique, a maximum of 13 hours of analgesia is obtained, even with a long-acting local anesthetic and adjuvants. For painful surgeries necessitating prolonged analgesia of more than 24 hours, continuous regional analgesia techniques have been described, using perinervous catheters. However, these techniques have a high incidence of failure. The most frequent causes of failure are catheter displacements, misplacement, and the distance between the targeted nerves. Many approaches have been described to insert these catheters (axillary, infraclavicular and supraclavicular), but the optimal approach remains unknown. Therefore, international and even local practices vary widely.
Investigators plan to compare the axillary and the infraclavicular approaches in this randomized study, on 60 patients. In every group, an initial bolus will be given and then a perinervous catheter will be inserted by the allocated approach. The surgery will be done under regional anesthesia. The co-analgesia, the local anesthetic infusion and the follow-up will be standardized and will be the same in the two groups.
The primary outcome will be an anesthesia score on 16 points previously described in other similar publication. The primary outcome will be at 24 hours after block realization, but it will be repeated at 48 hours. It will evaluate the degree of sensitive and motor blockade of every major nerve of the hand. Secondary outcomes will be the time, comfort and adverse effects of the technique, and postoperative pain, analgesia, satisfaction and adverse effects.
The aim of this study is to help determine the optimal approach for brachial plexus catheter insertion, in order to improve analgesia, to decrease morphine consumption and its related adverse effects, and to improve patients and caregivers satisfaction.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Axillary block group | Experimental | Procedure: Hand surgery under regional anesthesiaInitial bolus will be given and then a perinervous catheter will be inserted by the axillary approach. |
| Infraclavicular block group | Experimental | Procedure: Hand surgery under regional anesthesiaInitial bolus will be given and then a perinervous catheter will be inserted by the infraclavicular approach. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients with a social insurance number
- ASA 1-3
- Patients undergoing hand surgery requiring a continuous brachial plexus block
- Elective or urgent surgery
- Effective contraception (HAS criteria)
Key exclusion criteria (8 listed)
- Contraindication to the installation of a continuous brachial plexus block (coagulopathy, refusal, allergy to the medication)
- Preexisting neuropathy
- Pregnancy
- Arteriovenous fistula
- Obesity (BMI >40)
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 |
|---|---|---|
| Hand surgery under regional anesthesiaIn both groups, patients will benefit from an initial standardized bolus (long-acting local anesthetic, ropivacaine) to cover the operative period, via the allocated approach. Ultrasound guidance and the recommended standards monitors will be used in both groups. After the initial bolus, a catheter will be inserted via the allocated approach. Surgery will be done under regional anesthesia alone, unless there is a medical contraindication or if the patient asks for general anesthesia. Post-operative analgesia will be standardized with regular paracetamol, regular NSAID (Nonsteroidal anti-inflammatory drugs) and oxycodone if needed. The local anesthetics perfusion will be standardized. There will be a medical follow up at 24 and 48 hours where data will be collected. | Procedure or surgery | Axillary block group, Infraclavicular block group |
Primary outcome
Anesthesia score
Time frame: 24 hours after block realization
Min/Max : 0 for no anesthesia to 16 total anesthesia Addition of Motor block score (0-2) and Sensitive block score (0-2) for the 4 main nerves of the hand
9 secondary outcomes
Duration of catheter insertion procedure
Time frame: During block realization
Maximal pain during the surgery procedure
Time frame: During surgery
Maximal pain during the first 24 hours
Time frame: During the first 24 hours after block realization
Anesthesia score
Time frame: 30 minutes after block realization
Anesthesia score
Time frame: 48 hours after block realization
Total morphine consumption
Time frame: 24 and 48 hours after block realization
Mean pain at rest and with movement
Time frame: 24 and 48 hours after block realization
Quality of sleep
Time frame: Over first night after block realization
Patient satisfaction
Time frame: 48 hours after block realization
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Hand surgery under regional anesthesia in people with Anesthesia, Regional and Brachial Plexus Block, run by University Hospital, Bordeaux.
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 8 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: withdrawn, as of the sponsor's last update on 17 Mar 2023. 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 was withdrawn before enrolling participants, so there are no results.
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?
Anesthesia score (time frame: 24 hours after block realization). 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 17 Mar 2023.