Hand SurgeryWalantBAXNCT04306666
Early Rehabilitation After Hand or Wrist Ambulatory Surgery : How to Preserve Locomotion at Home Without Rebound Pain?
An observational study of Hand Surgery and Wrist Surgery, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The purpose of this retrospective study is to compare the analgesic efficacy of Walant " Wide Awake Local Anesthesia No Tourniquet " with lidocaine and bupivacaine versus axillary brachial plexus block using mepivacaïne, both performed by anesthesiologists, after hand or wrist ambulatory surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand Surgery, Wrist Surgery
- What is being tested?
- Regional anesthesia
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 30 Dec 2019to 31 Dec 2020
- Phase
- Observational
- 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
Study population: All adults patients scheduled for hand or wrist ambulatory surgery
Who may be able to join
- All adults patients scheduled for hand or wrist ambulatory surgery since 2016
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Uhmontpellier
Montpellier, 34295
Olivier CHOQUET, MD, 467338256 ext. 33, o-choquet@chu-montpellier.fr
About this study
Official title: Early Rehabilitation After Hand or Wrist Ambulatory Surgery : How to Preserve Locomotion at Home Without Rebound Pain? Study Walant " Wide Awake Local Anesthesia No Tourniquet " Versus Axillary Brachial Plexus Block.
The purpose of this retrospective study is to compare the analgesic efficacy of Walant " Wide Awake Local Anesthesia No Tourniquet " with lidocaine and bupivacaine versus axillary brachial plexus block using mepivacaïne, both performed by anesthesiologists, after hand or wrist ambulatory surgery.
The main objective is to prove that Walant block improve pain relief at home measuring time to first analgesic request.
The secondary objectives are to compare maximal pain, consumption of supplementary analgesics, and the duratin of sensory block between groups.
Read the detailed description
data will be collected on patient records and will be compared between groups of regional anesthesia.
Data will be :
- time to first analgesic request
- sensory block
- rescue analgesia during the first 24 hours after surgery
- maximal pain score during the first 24 hours after surgery
- patient satisfaction of managing care
- Conditions
- Hand Surgery, Wrist Surgery
- Being tested
- Regional anesthesia
- Keywords
- Regional anesthesia, Walant block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional anesthesiaOther
Injection of local anesthetics by a regional anesthesia named Walant block (Wide Awak Local anesthesia No Tourniquet)or by axillary brachial plexus block.
| Study group | Role | What they receive |
|---|---|---|
| Walant group | Walant group Receives: Other: Regional anesthesia | |
| Axillary Brachial Plexus Block | Axillary Brachial Plexus Block Receives: Other: Regional anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of analgesia
time to first rescue analgesic request (opioid)
Measured: 24 hours
Secondary outcomes (3)
maximal pain score during the first 24 hours after surgery
Pain assessments during first 24 hours : maximal pain score during the first 24 hours after surgery
Measured: 24 hours
total rescue analgesia amounts the first 24 hours after surgery
Pain assessments during first 24 hours : total rescue analgesia amounts the first 24 hours after surgery
Measured: 24 hours
duration of sensory block
Pain assessments during first 24 hours : duration of sensory block
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start30 Dec 2019
- Primary completion1 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
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.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- olivier CHOQUET, PhD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04306666
- Sponsor's protocol ID
- RECHMPL19_0429
- Acronym
- WalantBAX
- Status last verified
- Mar 2020
- First submitted
- 29 Nov 2019
- Last updated
- 13 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Rehabilitation After Hand or Wrist Ambulatory Surgery : How to Preserve Locomotion at Home Without Rebound Pain? Study Walant " Wide Awake Local Anesthesia No Tourniquet " Versus Axillary Brachial Plexus Block.
- ClinicalTrials.gov ID
- NCT04306666
- Acronym / sponsor ID
- WalantBAX / RECHMPL19_0429
- Conditions
- Hand Surgery, Wrist Surgery
- Keywords
- Regional anesthesia, Walant block
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 30 Dec 2019 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 13 Mar 2020 (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.
The purpose of this retrospective study is to compare the analgesic efficacy of Walant " Wide Awake Local Anesthesia No Tourniquet " with lidocaine and bupivacaine versus axillary brachial plexus block using mepivacaïne, both performed by anesthesiologists, after hand or wrist ambulatory surgery.
The main objective is to prove that Walant block improve pain relief at home measuring time to first analgesic request.
The secondary objectives are to compare maximal pain, consumption of supplementary analgesics, and the duratin of sensory block between groups.
Detailed description
data will be collected on patient records and will be compared between groups of regional anesthesia.
Data will be :
- time to first analgesic request
- sensory block
- rescue analgesia during the first 24 hours after surgery
- maximal pain score during the first 24 hours after surgery
- patient satisfaction of managing care
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Walant group | – | Other: Regional anesthesiaWalant group |
| Axillary Brachial Plexus Block | – | Other: Regional anesthesiaAxillary Brachial Plexus Block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adults patients scheduled for hand or wrist ambulatory surgery
Key inclusion criteria (1 listed)
- All adults patients scheduled for hand or wrist ambulatory surgery since 2016
Key exclusion criteria (1 listed)
- NA
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 |
|---|---|---|
| Regional anesthesiaInjection of local anesthetics by a regional anesthesia named Walant block (Wide Awak Local anesthesia No Tourniquet)or by axillary brachial plexus block. | Other | Axillary Brachial Plexus Block, Walant group |
Primary outcome
duration of analgesia
Time frame: 24 hours
time to first rescue analgesic request (opioid)
3 secondary outcomes
maximal pain score during the first 24 hours after surgery
Time frame: 24 hours
total rescue analgesia amounts the first 24 hours after surgery
Time frame: 24 hours
duration of sensory block
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
- Individual participant dataSharing planned: Undecided. NC
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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.
olivier CHOQUET, PhD study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hand Surgery and Wrist Surgery, run by University Hospital, Montpellier at 1 site 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 13 Mar 2020. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact olivier CHOQUET, PhD (467338256 ext. 33, o-choquet@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of analgesia (time frame: 24 hours). 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 13 Mar 2020.