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

NCT05343299 | Completed Phase 1

• 2 other identifiers: NIMAO/2021-1/YG-012021-006493-23
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia, Local; Hand Surgery; Wrist Surgery; Elbow Surgery

Keywords

lidocaine,; ropivacaine,; carpal tunnel syndrome,; trigger finger

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  48 hours after surgery

Secondary Outcomes (14)

• Pain on a numerical visual analog scale : Experimental group

  Day 0

• Pain on a numerical visual analog scale : Experimental group

  Day 1

• Pain on a numerical visual analog scale : Experimental group

  Day 2

• Pain on a numerical visual analog scale : Experimental group

  Day 7

• Neuropathic pain according to the DN4 questionnaire: Experimental group

  At 3 months

Other Outcomes (10)

• Sex of patients in the Experimental group

  Day 0

• Age of patients in the Experimental group

  Day 0

• Weight of patients in the Experimental group

  Day 0

Study Arms (2)

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

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

Combination Product: Ambulatory surgery under Lidocaine alone

Interventions

Ambulatory surgery under a combination of Lidocaine and Ropivacaine COMBINATION_PRODUCT

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

Also known as: Local anesthesia with lidocaine and ropivacaine

Patients undergoing hand surgery with a combination of lidocaine and ropivacaine

Ambulatory surgery under Lidocaine alone COMBINATION_PRODUCT

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.

Also known as: Local anesthesia with lidocaine alone

Patients undergoing hand surgery with lidocaine alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

Yann GRICOURT

Nîmes, Gard, 30029, France

Location

Related Publications (1)

• 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.

  PMID: 40272357 RESULT

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Trigger Finger Disorder

Interventions

Anesthesia, Local; Lidocaine; Ropivacaine

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Tendon Entrapment; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The patient will be blinded to his or her anesthesia protocol. The investigating physician who performs the anesthesia and surgery will be different from the evaluators (IDE, hospital CRA, evaluating physician) who will be blinded to the patient's assignment group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: April 15, 2022
• First Posted: April 25, 2022
• Study Start: May 30, 2022
• Primary Completion: June 25, 2023
• Study Completion: September 25, 2023
• Last Updated: December 10, 2025

Record last verified: 2025-12

Locations

FR (1)