Clinical trial NCT05343299: Postoperative Experience of 2 WALANT-type Modes of Anesthesia Used in Ambulatory Surgery of the Upper Limb.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Anesthesia, Local
Hand Surgery
Wrist Surgery
Elbow Surgery
Keywords: lidocaine,
ropivacaine,
carpal tunnel syndrome,
trigger finger
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* Anesthesia by local infiltration in the extremities
* Coronary insufficiency.
* Ventricular rhythm disorders.
* Severe arterial hypertension.
* Obstructive cardiomyopathy.
* Hyperthyroidism.
* Hypovolemia.

Primary outcomes:
measure: Experimental group: experience of patients in the Lidocaine + Ropivacaine group
timeFrame: 48 hours after surgery
measure: Control group: experience of patients in the Lidocaine alone group
timeFrame: 48 hours after surgery
Secondary outcomes:
measure: Pain on a numerical visual analog scale : Experimental group
timeFrame: Day 0
measure: Pain on a numerical visual analog scale : Experimental group
timeFrame: Day 1
measure: Pain on a numerical visual analog scale : Experimental group
timeFrame: Day 2
measure: Pain on a numerical visual analog scale : Experimental group
timeFrame: Day 7
measure: Neuropathic pain according to the DN4 questionnaire: Experimental group
timeFrame: At 3 months
measure: Satisfaction with perioperative management: Experimental group according to the EVAN-LR questionnaire
timeFrame: Day 0
measure: Clinical or biological adverse events: Experimental group
timeFrame: From Day 0 to Day 2
measure: Pain on a visual numerical scale : Control group
timeFrame: Day 0
measure: Pain on a visual numerical scale : Control group
timeFrame: Day 1
measure: Pain on a visual numerical scale : Control group
timeFrame: Day 2
measure: Pain on a visual numerical scale : Control group
timeFrame: Day 7
measure: Neuropathic pain according to the DN4 questionnaire: Control group
timeFrame: At 3 months
measure: Satisfaction with perioperative management according to the EVAN-LR questionnaire Control group
timeFrame: Day 0
measure: Clinical or biological adverse events: Control group
timeFrame: From Day 0 to Day 2
Other outcomes:
measure: Sex of patients in the Experimental group
timeFrame: Day 0
measure: Age of patients in the Experimental group
timeFrame: Day 0
measure: Weight of patients in the Experimental group
timeFrame: Day 0
measure: Height of patients in the Experimental group
timeFrame: Day 0
measure: Body Mass Index of patients in the Experimental group
timeFrame: Day 0
measure: Sex of patients in the Control group
timeFrame: Day 0
measure: Age of patients in the Control group
timeFrame: Day 0
measure: Weight of patients in the Control group
timeFrame: Day 0
measure: Height of patients in the Control group
timeFrame: Day 0
measure: Body Mass Index of patients in the Control group
timeFrame: Day 0
Locations:
city: Nîmes
country: France
facility: Yann GRICOURT
state: Gard
Study officials:
References: