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Anesthesia, LocalPhase 1ROPIWANCT05343299

Postoperative Experience of 2 WALANT-type Modes of Anesthesia Used in Ambulatory Surgery of the Upper Limb.

A Phase 1 study testing Ambulatory surgery under Lidocaine alone and Ambulatory surgery under a combination of Lidocaine and Ropivacaine in people with Anesthesia, Local and Hand Surgery, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Distal surgery of the upper limb under local anesthesia using the WALANT technique (Wide Awake Local Anesthesia No Tourniquet) has become the standard care in orthopedic surgery. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anesthesia, Local, Hand Surgery, Wrist Surgery
What is being tested?
Ambulatory surgery under Lidocaine alone and Ambulatory surgery under a combination of Lidocaine and Ropivacaine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
91 participants
Where
1 siteFrance
Study dates
30 May 2022to 25 Sep 2023
Phase
Phase 1
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

  • Patient eligible for outpatient surgery under WALANT for:
  • Hand surgery such as carpal tunnel, stub finger, Dupuytren's disease;
  • Elbow surgery such as ulnar nerve compression and lacertus fibrosus syndrome.
  • Patient with free and informed consent.
  • Patient with signed consent form.
  • Patient affiliated to or beneficiary of a health insurance plan.

Who cannot join

  • Ischemic vascular disorders such as severe Raynaud's disease, Buerger's disease, diabetic microangiopathy.
  • Scleroderma.
  • Known allergy to ropivacaine or lidocaine and possibility of cross-allergy with other amide-bound local cross-allergy with other local anesthetics with amide linkage.
  • Severe hepatic impairment
  • Acute porphyria.
  • Intravascular anesthesia.
Show all 13Show fewer
  • Anesthesia by local infiltration in the extremities
  • Coronary insufficiency.
  • Ventricular rhythm disorders.
  • Severe arterial hypertension.
  • Obstructive cardiomyopathy.
  • Hyperthyroidism.
  • Hypovolemia.

Trial locations and contacts

1 site in 1 country.

France1 site
  • Yann GRICOURT

    Nîmes, Gard, 30029

Other trials in France

About this study

Official title: Evaluation of Postoperative Experience of Two WALANT-type Modes of Anesthesia (Lidocaine Alone or Combined With Ropivacaine) Used in Ambulatory Surgery of the Upper Limb. A Single-center Prospective Randomized, Single-blind Study

Distal surgery of the upper limb under local anesthesia using the WALANT technique (Wide Awake Local Anesthesia No Tourniquet) has become the standard care in orthopedic surgery. The principle is that the operator infiltrates the whole surgical area with a 1% lidocaine solution combined with adrenaline (diluted to 1/200,000) so that all distal surgery of the upper limb can be performed without a tourniquet. Thus, the perioperative course and management of the patient in the operating room and the constraints inherent to general anesthesia are largely reduced. Also, the material cost is considerably reduced. However, WALANT often induces significant pain when the patient leaves the operating room to return home. This effect is related to the pharmacological formulation of lidocaine which has a short half-life (< 3h). To reduce this inconvenience of early block removal, adding a local anesthetic with a longer duration of action (ropivacaine) to lidocaine would extend the duration of the analgesic, improving postoperative experience and satisfaction. The main objective of this research is to evaluate the effect of two WALANT anesthesia protocols (with or without the addition of ropivacaine) on the postoperative experience of patients (QoR-40 questionnaire) 48 hours after outpatient hand surgery.

Read the detailed description

Secondary objectives include the evaluation of short-term pain (Day 0 to Day 7), chronicisation of pain at 3 months, patient satisfaction regarding perioperative management and tolerance in both groups.

This is a monocentric, prospective, randomized, single-blind study. 80 adult patients, eligible for outpatient surgery under under WALANT for hand surgery such as carpal tunnel, stub finger, Dupuytren's disease or elbow surgery such as ulnar nerve compression and lacertus fibrosus syndrome, will be recruited during their care in the orthopedic and trauma surgery department at Nîmes University Hospital over an estimated period of 12 months. After receiving information, the intervention visit will be planned within 21 days. After collecting consent and checking the selection criteria, patients will be randomized (1:1 stratified according to hand/elbow surgery) for a procedure under WALANT anesthesia with 10 to 20 ml of 1% lidocaine (10 mg/mL) (depending on the procedure) combined with adrenaline (0.005mg/ml) with or without the addition of 15mg ropivacaine. An evaluation of the pain via a visual analog scale (0 to 10) will be carried out before discharge from the service and by telephone on Day 1 according to the current care then at Days 2 and 3 and 7 for the research. The patients will also have to answer questionnaires on their perioperative management (Evaluation of the experience of local anaesthesia or EVAN-LR) before leaving the department and then on the postoperative experience (Quality of Recovery or QoR-40) at D2 and the possible "chronicisation" of pain at 3 months (neuropathic pain or DN4) by telephone. Possible adverse events will be collected up to D7.

Being tested
Ambulatory surgery under Lidocaine alone, Ambulatory surgery under a combination of Lidocaine and Ropivacaine
Keywords
lidocaine,, ropivacaine,, carpal tunnel syndrome,, trigger finger
Medical subject headings
Carpal Tunnel Syndrome, Trigger Finger Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ambulatory surgery under Lidocaine aloneCombination product

    Also called Local anesthesia with lidocaine alone

    In this conventional procedure group, the anesthetic solution is administered subcutaneously and by infiltration into the surgical area. A maximum volume of 20 ml (dose dictated by the operation) of the solution is thus injected by the operator: Lidocaine 10mg/mL combined with adrenaline 0.005mg/mL administered at a dose of 10 to 20 mL, i.e. a total of 50 to 200 mg of lidocaine.

  • Ambulatory surgery under a combination of Lidocaine and RopivacaineCombination product

    Also called Local anesthesia with lidocaine and ropivacaine

    In this experimental procedure group, the anesthetic solution is administered subcutaneously and by infiltration into the surgical area. A maximum volume of 20 ml (dose dictated by the operation) of the solution is thus injected by the operator: Lidocaine 10mg/mL combined with adrenaline 0.005mg/mL administered at a dose of 18 mL + ropivacaine 7.5 mg/mL 2 mL or 15 mg. For a total of 20 mL: lidocaine 9mg/mL, ropivacaine 0.75 mg/mL, adrenaline 0.005 mg/mL

Study groups in NCT05343299
Study groupRoleWhat they receive
Patients undergoing hand surgery with a combination of lidocaine and ropivacaineExperimentalPatients undergoing Wide Awake Local Anesthesia No Tourniquet -type hand surgery with lidocaine
Receives: Combination Product: Ambulatory surgery under a combination of Lidocaine and Ropivacaine
Patients undergoing hand surgery with lidocaine aloneActive comparatorPatients undergoing Wide Awake Local Anesthesia No Tourniquet -type hand surgery with lidocaine
Receives: Combination Product: Ambulatory surgery under Lidocaine alone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Experimental group: experience of patients in the Lidocaine + Ropivacaine group

    The postoperative experience will be evaluated by the Quality of Recovery questionnaire (QoR-40) at 48 h postoperative.

    This questionnaire includes sections on comfort, pain, support, emotions and physical independence. Each section has questions to be answered on a scale of 1 to 5 in which 1 = very poor and 5 = excellent.

    Measured: 48 hours after surgery

  2. Control group: experience of patients in the Lidocaine alone group

    The postoperative experience will be evaluated by the Quality of Recovery questionnaire (QoR-40) at 48 h postoperative.

    This questionnaire includes sections on comfort, pain, support, emotions and physical independence. Each section has questions to be answered on a scale of 1 to 5 in which 1 = very poor and 5 = excellent.

    Measured: 48 hours after surgery

Secondary outcomes (14)
  1. Pain on a numerical visual analog scale : Experimental group

    Pain will be evaluated on a numerical visual analog scale in the experimental group.

    The scale ranges from 0 to 10 in which 0 = no pain and 10 = worst possible pain.

    Measured: Day 0

  2. Pain on a numerical visual analog scale : Experimental group

    Pain will be evaluated on a numerical visual analog scale in the experimental group.

    The scale ranges from 0 to 10 in which 0 = no pain and 10 = worst possible pain.

    Measured: Day 1

  3. Pain on a numerical visual analog scale : Experimental group

    Pain will be evaluated on a numerical visual analog scale in the experimental group.

    The scale ranges from 0 to 10 in which 0 = no pain and 10 = worst possible pain.

    Measured: Day 2

  4. Pain on a numerical visual analog scale : Experimental group

    Pain will be evaluated on a numerical visual analog scale in the experimental group.

    The scale ranges from 0 to 10 in which 0 = no pain and 10 = worst possible pain.

    Measured: Day 7

  5. Neuropathic pain according to the DN4 questionnaire: Experimental group

    Pain in the experimental group will be evaluated by telephone using the DN4 questionnaire. This is a clinician-administered questionnaire consisting of 10 items. Seven items related to pain quality (i.e. sensory and pain descriptors) are based on an interview with the patient and 3 items based on the clinical examination. The DN4 (which stands for Douleur Neuropathique 4 i.e. Neuropathic Pain 4) is one of the questionnaires that can be useful in diagnosing neuropathic pain. It was initially written in French but immediately translated into English by the same team. The scale has been widely used since 2005 due to its simplicity. It evaluates neuropathic pain following central and peripheral neurological lesions. It is also used for diagnostic purposes, allowing the clinician to determine whether the pain is of neuropathic origin.This questionnaire has been well validated by a number of studies.

    Measured: At 3 months

  6. Satisfaction with perioperative management: Experimental group according to the EVAN-LR questionnaire

    Patient satisfaction with perioperative management will be evaluated using the EVAN-LR (Evaluation du Vécu de l'Anesthésie LocoRégionale = Assessment of the Experience of Locoregional Anesthesia) self-reported questionnaire. This questionnaire, which specifically assesses the satisfaction of patients undergoing regional anesthesia, comprises 19 items, structured in a global index and five dimensions: Attention, Information, Discomfort, Waiting, and Pain. The consequences of staying alert during regional anesthesia are specifically addressed by two items.

    Measured: Day 0

  7. Clinical or biological adverse events: Experimental group

    All clinical or biological adverse events will be recorded on the electronic reporting form from Day 0 up to Day 2. These include bleeding, hematoma, rehospitalization, paresthesia, nausea and vomiting after removal of anesthesia.

    Measured: From Day 0 to Day 2

  8. Pain on a visual numerical scale : Control group

    Pain will be evaluated on a visual numerical scale in the control group

    Measured: Day 0

  9. Pain on a visual numerical scale : Control group

    Pain will be evaluated on a visual numerical scale in the control group

    Measured: Day 1

  10. Pain on a visual numerical scale : Control group

    Pain will be evaluated on a visual numerical scale in the control group

    Measured: Day 2

  11. Pain on a visual numerical scale : Control group

    Pain will be evaluated on a visual numerical scale in the control group

    Measured: Day 7

  12. Neuropathic pain according to the DN4 questionnaire: Control group

    Pain in the control group will be evaluated by telephone using the DN4 questionnaire. This is a clinician-administered questionnaire consisting of 10 items. Seven items related to pain quality (i.e. sensory and pain descriptors) are based on an interview with the patient and 3 items based on the clinical examination. The DN4 (which stands for Douleur Neuropathique 4 i.e. Neuropathic Pain 4) is one of the questionnaires that can be useful in diagnosing neuropathic pain. It was initially written in French but immediately translated into English by the same team. The scale has been widely used since 2005 due to its simplicity. It evaluates neuropathic pain following central and peripheral neurological lesions. It is also used for diagnostic purposes, allowing the clinician to determine whether the pain is of neuropathic origin.This questionnaire has been well validated by a number of studies.

    Measured: At 3 months

  13. Satisfaction with perioperative management according to the EVAN-LR questionnaire Control group

    Patient satisfaction with perioperative management will be evaluated using the EVAN-LR (Evaluation du Vécu de l'Anesthésie LocoRégionale = Assessment of the Experience of Locoregional Anesthesia) self-reported questionnaire. This questionnaire, which specifically assesses the satisfaction of patients undergoing regional anesthesia, comprises 19 items, structured in a global index and five dimensions: Attention, Information, Discomfort, Waiting, and Pain. The consequences of staying alert during regional anesthesia are specifically addressed by two items.

    Measured: Day 0

  14. Clinical or biological adverse events: Control group

    All clinical or biological adverse events will be recorded on the electronic reporting form from Day 0 up to Day 2. These include bleeding, hematoma, rehospitalization, paresthesia, nausea and vomiting after removal of anesthesia.

    Measured: From Day 0 to Day 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2022
  2. Study start30 May 2022
  3. Primary completion25 Jun 2023
  4. Study completion25 Sep 2023

Resources

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a single-center, prospective, randomized, single-blind superiority study comparing two management modalities in WALANT-type anesthesia for ambulatory hand surgery: addition of ropivacaine to lidocaine (experimental group) versus lidocaine alone (control group). Jardé Law Research Involving Human Persons category 1
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
91 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05343299
Sponsor's protocol ID
NIMAO/2021-1/YG-01
Other IDs
2021-006493-23
Acronym
ROPIWA
Status last verified
Dec 2025
First submitted
15 Apr 2022
Last updated
10 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Gricourt Y, Occean BV, Favrelle A, Chevallier T, Mares O, Cuvillon P. Mixture of Lidocaine and Ropivacaine as a Local Anesthetic in WALANT Surgery: A Prospective Randomized Study. J Hand Surg Am. 2025 Jul;50(7):790-796. doi: 10.1016/j.jhsa.2025.03.010. Epub 2025 Apr 24.

    PubMed 40272357

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ambulatory surgery under Lidocaine alone and Ambulatory surgery under a combination of Lidocaine and Ropivacaine in people with Anesthesia, Local and Hand Surgery, run by Centre Hospitalier Universitaire de Nīmes 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 6 inclusion and 13 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 10 Dec 2025. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Experimental group: experience of patients in the Lidocaine + Ropivacaine group (time frame: 48 hours after surgery). The study lists 2 primary outcomes in all. 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 NCT05343299, 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 10 Dec 2025.

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