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.
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.
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.
- Conditions
- Anesthesia, Local, Hand Surgery, Wrist Surgery, Elbow Surgery
- 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 group | Role | What they receive |
|---|---|---|
| Patients undergoing hand surgery with a combination of lidocaine and ropivacaine | Experimental | Patients 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 alone | Active comparator | Patients 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.
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
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)
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
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
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
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
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
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
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
Pain on a visual numerical scale : Control group
Pain will be evaluated on a visual numerical scale in the control group
Measured: Day 0
Pain on a visual numerical scale : Control group
Pain will be evaluated on a visual numerical scale in the control group
Measured: Day 1
Pain on a visual numerical scale : Control group
Pain will be evaluated on a visual numerical scale in the control group
Measured: Day 2
Pain on a visual numerical scale : Control group
Pain will be evaluated on a visual numerical scale in the control group
Measured: Day 7
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
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
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.
- First posted25 Apr 2022
- Study start30 May 2022
- Primary completion25 Jun 2023
- Study completion25 Sep 2023
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 Anesthesia, LocalStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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 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)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05343299
- Acronym / sponsor ID
- ROPIWA / NIMAO/2021-1/YG-01
- Conditions
- Anesthesia, Local, Hand Surgery, Wrist Surgery, Elbow Surgery
- Keywords
- lidocaine,, ropivacaine,, carpal tunnel syndrome,, trigger finger
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 30 May 2022 (actual)
- Primary completion
- 25 Jun 2023 (actual)
- Study completion
- 25 Sep 2023 (actual)
- First posted
- 25 Apr 2022 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing hand surgery with a combination of lidocaine and ropivacaine | Experimental | Combination Product: Ambulatory surgery under a combination of Lidocaine and RopivacainePatients undergoing Wide Awake Local Anesthesia No Tourniquet -type hand surgery with lidocaine |
| Patients undergoing hand surgery with lidocaine alone | Active comparator | Combination Product: Ambulatory surgery under Lidocaine alonePatients undergoing Wide Awake Local Anesthesia No Tourniquet -type hand surgery with lidocaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
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 |
|---|---|---|
| Ambulatory surgery under Lidocaine aloneAlso: Local anesthesia with lidocaine aloneIn 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. | Combination product | Patients undergoing hand surgery with lidocaine alone |
| Ambulatory surgery under a combination of Lidocaine and RopivacaineAlso: Local anesthesia with lidocaine and ropivacaineIn 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 | Combination product | Patients undergoing hand surgery with a combination of lidocaine and ropivacaine |
Primary outcome
Experimental group: experience of patients in the Lidocaine + Ropivacaine group
Time frame: 48 hours after surgery
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.
Control group: experience of patients in the Lidocaine alone group
Time frame: 48 hours after surgery
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.
14 secondary outcomes
Pain on a numerical visual analog scale : Experimental group
Time frame: Day 0
Pain on a numerical visual analog scale : Experimental group
Time frame: Day 1
Pain on a numerical visual analog scale : Experimental group
Time frame: Day 2
Pain on a numerical visual analog scale : Experimental group
Time frame: Day 7
Neuropathic pain according to the DN4 questionnaire: Experimental group
Time frame: At 3 months
Satisfaction with perioperative management: Experimental group according to the EVAN-LR questionnaire
Time frame: Day 0
Clinical or biological adverse events: Experimental group
Time frame: From Day 0 to Day 2
Pain on a visual numerical scale : Control group
Time frame: Day 0
Pain on a visual numerical scale : Control group
Time frame: Day 1
Pain on a visual numerical scale : Control group
Time frame: Day 2
Pain on a visual numerical scale : Control group
Time frame: Day 7
Neuropathic pain according to the DN4 questionnaire: Control group
Time frame: At 3 months
Satisfaction with perioperative management according to the EVAN-LR questionnaire Control group
Time frame: Day 0
Clinical or biological adverse events: Control group
Time frame: From Day 0 to Day 2
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 10 Dec 2025.
- Results publication: PubMed 40272357Gricourt 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.
Related trials for Anesthesia, Local
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Recruiting
Minimum Effective Local Anesthetic Volume for Ultrasound Guided Superior Trunk Block
Musculoskeletal Diseases or Conditions
RecruitingPhase 3
A Study of Changes to Prostate Procedures
Prostate Cancer
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
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.
1 site in 1 country: see every site and its status.
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.