Wrist FractureBAXASSONCT04046744
Axillary Block in Association With Analgesic Truncal Blocks at the Elbow for Wrist Surgery.
A study testing Axillary brachial plexus block with a long-acting local anesthetic, Axillary brachial plexus block with a short-acting local anesthetic + Analgesic block at the elbow with a long-acting local anesthetic and Ropivacaine in people with Wrist Fracture, run by CMC Ambroise Paré at 7 sites in France.
Trial summary
Fractures of the forearm bones that occur around the wrist are common in the elderly. Standard anesthesia for its surgical treatment is regional anesthesia (RA): supraclavicular block, infraclavicular block or axillary block (BAX). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wrist Fracture
- What is being tested?
- Axillary brachial plexus block with a long-acting local anesthetic, Axillary brachial plexus block with a short-acting local anesthetic + Analgesic block at the elbow with a long-acting local anesthetic and Ropivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 7 sitesFrance
- Study dates
- 7 Oct 2019to 15 Sep 2022
- 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
- Patients undergoing wrist fracture surgery under regional anesthesia
- Consent for participation
- Affiliation to the French social security system
Who cannot join
- Chronic use of opiod analgesics
- Chronic pain syndrome or fibromyalgia
- Contraindication for locoregional anesthesia
- Contraindication for opioid
- ASA IV
- Pregnant or breastfeeding women
- Patients under protection of the adults (guardianship, curators or safeguard of justice)
- Communication difficulties or neuropsychiatric disorder
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Hôpital Privé Paul D'Egine
Champigny-sur-Marne, Île-de-France Region, 94500
Clinique du Pré
Le Mans, Pays de la Loire Region, 72018
CMC Ambroise Paré
Neuilly-sur-Seine, Île-de-France Region, 92200
Hôpital Privé Armand Brillard
Nogent-sur-Marne, Île-de-France Region, 94130
Clinique Bizet
Paris, Île-de-France Region, 75016
Clinique Jouvenet
Paris, Île-de-France Region, 75016
Clinique Rémusat
Paris, Île-de-France Region, 75016
About this study
Official title: Axillary Block in Association With Analgesic Truncal Blocks of the Median and Radial Nerves at the Elbow for Wrist Surgery.
Fractures of the forearm bones that occur around the wrist are common in the elderly. Standard anesthesia for its surgical treatment is regional anesthesia (RA): supraclavicular block, infraclavicular block or axillary block (BAX). However, these techniques have some limitations, such as the postoperative pain management and the non-specificity of the analgesia. Indeed analgesia is not specific to the wrist and extends to the elbow and forearm, preventing rapid recovery of elbow flexion and extension when a long-acting local anesthetic (LA) is used. Recently RA techniques associating proximal anesthetic blocks with distal analgesic blocks have been proposed to serve a dual objective: good anesthesia for surgery and specific analgesia.
The hypothesis of this study is that, for the wrist surgery, axillary block using a short-acting LA combined with analgesic blocks at the elbow using a long-acting LA could provide a RA installation time reduction, an optimal surgical comfort, a longer post-operative analgesia duration and a faster recovery from motor block.
Read the detailed description
This multicenter, prospective, randomized, open-Label study compares two techniques :
- BAX (usual technique) : Axillary brachial plexus block (Axillary block) with a long-acting LA (Ropivacaine)
- BAX-Asso (experimental technique) : Axillary brachial plexus block (Axillary block) with a short-acting local anesthetic (Lidocaine) + Analgesic block at the elbow with a long-acting local anesthetic (Ropivacaine) Every block will be performed under Ultrasound. BAX will be performed using a multi-injection technique at contact with median (nM), radial (nR), ulnar (nU), musculocutaneous (nMC) and medial antebrachial cutaneous (nCMAB) nerves. 15-30 mL of LA will be injected.
Analgesic truncal blocks of the median and radial nerves will be performed at the elbow. 3-7 mL of LA will be injected.
- Conditions
- Wrist Fracture
- Being tested
- Axillary brachial plexus block with a long-acting local anesthetic, Axillary brachial plexus block with a short-acting local anesthetic + Analgesic block at the elbow with a long-acting local anesthetic, Ropivacaine, Lidocaine
- Keywords
- Regional anesthesia, Analgesia, Ultrasound
- Medical subject headings
- Wrist Fractures, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axillary brachial plexus block with a long-acting local anestheticProcedure or surgery
axillary block with 15-30 ml Ropivacaine 0,5%.
Axillary brachial plexus block with a short-acting local anesthetic + Analgesic block at the elbow with a long-acting local anestheticProcedure or surgery
axillary block with 15-30 ml Lidocaine 1,5% + radial and medial nerve block at the elbow with 3-7 ml Ropivacaine 0,5%.
RopivacaineDrug
axillary block with 15-30 ml Ropivacaine 0,5%
RopivacaineDrug
radial and medial nerve block at the elbow with 3-7 ml Ropivacaine 0,5%
LidocaineDrug
axillary block with 15-30 ml Lidocaine 1,5%
| Study group | Role | What they receive |
|---|---|---|
| BAX | Active comparator | Not described Receives: Procedure: Axillary brachial plexus block with a long-acting local anesthetic; Drug: Ropivacaine |
| BAX-Asso | Experimental | Not described Receives: Procedure: Axillary brachial plexus block with a short-acting local anesthetic + Analgesic block at the elbow with a long-acting local anesthetic; Drug: Ropivacaine; Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of pain when the patient recovers the flexion of the forearm on the arm
Pain VRS ranging from 0 to 10 (0=no pain, 10=worst possible pain)
Measured: 24 hours
Secondary outcomes (9)
Duration of motor block at the elbow
Time between the performance of regional anesthesia and the elbow flexion recovery
Measured: 24 hours
Axillary block success
Assess of motor block and sensory perception to pin-prick in the distribution of the five terminal branches at 10, 20, and 30 minutes postinjection.
Motor block: complete (2=paralysis), partial (1=paresis), or none (0). Motor function assessed in the following manner: wrist and finger flexion (median nerve), wrist and finger extension (radial nerve), thumb adduction and flexor carpi ulnaris flexion (ulnar nerve), and biceps flexion (musculocutaneous nerve).
Sensory block: complete/anesthesia (2=loss of sensation to pinprick), partial/analgesia (1=dull sensation to pinprick), or none (0=sharp sensation to pinprick).
Sensory distribution assessed in the following areas: thenar eminence and thumb tip (median nerve), dorsum of hand (radial nerve), fifth digit fingertip (ulnar nerve), lateral aspect of forearm (musculocutaneous nerve) and medial aspect of forearm (medial antebrachial cutaneous nerve).
Successful blockade is defined by a sensory-motor score ≥ 3.
Measured: 40 minutes
Feasibility of the wrist surgery
Usage (or not) of an additional anesthetic procedure to perform the surgery
Measured: 2 hours
Duration of postoperative analgesia
Time between the performance of regional anesthesia and the first dose of rescue analgesia with opioides.
Measured: 72 hours
Postoperative morphine consumption
Cumulated dose of oxynorm (mg)
Measured: 48 hours
Sleep quality
Incidence of sleep disorders
Measured: Day 2 After Surgery
Complications during block performance
Incidence of vascular puncture, paresthesia, intraneural injection and intravascular passage
Measured: 15 minutes
Complications immediately after block
Onset of vertigo, nausea or vomiting
Measured: 2 hours
Postoperative complications
Questionnaire about potential sensory anomalies such as numbness, itching or tingling
Measured: Day 15 After Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start7 Oct 2019
- Primary completion1 Sep 2022
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wrist FractureStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMC Ambroise Paré
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04046744
- Sponsor's protocol ID
- 2019/03
- Acronym
- BAXASSO
- Status last verified
- Jul 2026
- First submitted
- 5 Aug 2019
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Campion S, Le Sache F, Naudin C, Heriche C, Lemesle D, Cheikh M, Quemeneur C, Bloc S. Enhanced Recovery after Distal Radius Fracture Surgery using Combined Short- and Long-Acting Nerve Blocks: a Randomized Controlled Trial. Anaesth Crit Care Pain Med. 2026 Jul 11:101891. doi: 10.1016/j.accpm.2026.101891. Online ahead of print.
PubMed 42435885
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Axillary Block in Association With Analgesic Truncal Blocks of the Median and Radial Nerves at the Elbow for Wrist Surgery.
- ClinicalTrials.gov ID
- NCT04046744
- Acronym / sponsor ID
- BAXASSO / 2019/03
- Conditions
- Wrist Fracture
- Keywords
- Regional anesthesia, Analgesia, Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- CMC Ambroise ParéUniversity, hospital or other
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 6 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.
Fractures of the forearm bones that occur around the wrist are common in the elderly. Standard anesthesia for its surgical treatment is regional anesthesia (RA): supraclavicular block, infraclavicular block or axillary block (BAX). However, these techniques have some limitations, such as the postoperative pain management and the non-specificity of the analgesia. Indeed analgesia is not specific to the wrist and extends to the elbow and forearm, preventing rapid recovery of elbow flexion and extension when a long-acting local anesthetic (LA) is used. Recently RA techniques associating proximal anesthetic blocks with distal analgesic blocks have been proposed to serve a dual objective: good anesthesia for surgery and specific analgesia.
The hypothesis of this study is that, for the wrist surgery, axillary block using a short-acting LA combined with analgesic blocks at the elbow using a long-acting LA could provide a RA installation time reduction, an optimal surgical comfort, a longer post-operative analgesia duration and a faster recovery from motor block.
Detailed description
This multicenter, prospective, randomized, open-Label study compares two techniques :
- BAX (usual technique) : Axillary brachial plexus block (Axillary block) with a long-acting LA (Ropivacaine)
- BAX-Asso (experimental technique) : Axillary brachial plexus block (Axillary block) with a short-acting local anesthetic (Lidocaine) + Analgesic block at the elbow with a long-acting local anesthetic (Ropivacaine) Every block will be performed under Ultrasound. BAX will be performed using a multi-injection technique at contact with median (nM), radial (nR), ulnar (nU), musculocutaneous (nMC) and medial antebrachial cutaneous (nCMAB) nerves. 15-30 mL of LA will be injected.
Analgesic truncal blocks of the median and radial nerves will be performed at the elbow. 3-7 mL of LA will be injected.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BAX | Active comparator | Procedure: Axillary brachial plexus block with a long-acting local anesthetic, Drug: Ropivacaine |
| BAX-Asso | Experimental | Procedure: Axillary brachial plexus block with a short-acting local anesthetic + Analgesic block at the elbow with a long-acting local anesthetic, Drug: Ropivacaine, Drug: Lidocaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing wrist fracture surgery under regional anesthesia
- Consent for participation
- Affiliation to the French social security system
Key exclusion criteria (8 listed)
- Chronic use of opiod analgesics
- Chronic pain syndrome or fibromyalgia
- Contraindication for locoregional anesthesia
- Contraindication for opioid
- ASA IV
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 brachial plexus block with a long-acting local anestheticaxillary block with 15-30 ml Ropivacaine 0,5%. | Procedure or surgery | BAX |
| Axillary brachial plexus block with a short-acting local anesthetic + Analgesic block at the elbow with a long-acting local anestheticaxillary block with 15-30 ml Lidocaine 1,5% + radial and medial nerve block at the elbow with 3-7 ml Ropivacaine 0,5%. | Procedure or surgery | BAX-Asso |
| Ropivacaineaxillary block with 15-30 ml Ropivacaine 0,5% | Drug | BAX |
| Ropivacaineradial and medial nerve block at the elbow with 3-7 ml Ropivacaine 0,5% | Drug | BAX-Asso |
| Lidocaineaxillary block with 15-30 ml Lidocaine 1,5% | Drug | BAX-Asso |
Primary outcome
Level of pain when the patient recovers the flexion of the forearm on the arm
Time frame: 24 hours
Pain VRS ranging from 0 to 10 (0=no pain, 10=worst possible pain)
9 secondary outcomes
Duration of motor block at the elbow
Time frame: 24 hours
Axillary block success
Time frame: 40 minutes
Feasibility of the wrist surgery
Time frame: 2 hours
Duration of postoperative analgesia
Time frame: 72 hours
Postoperative morphine consumption
Time frame: 48 hours
Sleep quality
Time frame: Day 2 After Surgery
Complications during block performance
Time frame: 15 minutes
Complications immediately after block
Time frame: 2 hours
Postoperative complications
Time frame: Day 15 After Surgery
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 14 Jul 2026.
- Results publication: PubMed 42435885Campion S, Le Sache F, Naudin C, Heriche C, Lemesle D, Cheikh M, Quemeneur C, Bloc S. Enhanced Recovery after Distal Radius Fracture Surgery using Combined Short- and Long-Acting Nerve Blocks: a Randomized Controlled Trial. Anaesth Crit Care Pain Med. 2026 Jul 11:101891. doi: 10.1016/j.accpm.2026.101891. Online ahead of print.
- 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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Axillary brachial plexus block with a long-acting local anesthetic, Axillary brachial plexus block with a short-acting local anesthetic + Analgesic block at the elbow with a long-acting local anesthetic and Ropivacaine in people with Wrist Fracture, run by CMC Ambroise Paré at 7 sites in France.
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 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: finished, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. 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?
Level of pain when the patient recovers the flexion of the forearm on the arm (time frame: 24 hours). 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 NCT04046744, 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 14 Jul 2026.