Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The carpal tunnel release (CTR) is now performed almost exclusively under regional anesthesia (RA) in France. RA requires the use of a pneumatic tourniquet to limit blood flow to the operated extremity and create a bloodless surgical field for a clear visualization of the anatomic structures by the surgeon.
Multiple approaches to block the brachial plexus can be considered. The most common technique is the axillary block (BAX) that provides complete anesthesia for the patient's arm and forearm. This technique offers anesthesia not only for the surgical area but also for the root of the arm where the pneumatic tourniquet is placed. However this technique have limits: the persistence of a motor block in the arm and the forearm that is not compatible with a quick hospital discharge (short term ambulatory hospitalization) and the need for assistance with dressing and eating after surgery. More distal anesthetic techniques are proposed such as the troncular blocks (TRONC) that avoid motor block of the arm and offer an earlier recovery and autonomy for the patient. However, they lead to a poor tolerance to the tourniquet due to its application on a non-anesthetized area.The pain related to the pressure of the tourniquet can occur within the first few minutes of its inflation, get worse over time and persist for several minutes after its deflation. Therefore, TRONC procedure is less often performed compared to the BAX for major surgeries but it remains appropriate for CTR.
The Wide Awake Local Anesthesia No Tourniquet (WALANT) technique is widely used in Canada and has been proposed for hand and wirst minor surgeries. WALANT uses a combination of a local anesthetic (LA) and epinephrine to induce anesthesia and hemostasis in the area of the surgical procedure in order to allow surgeries to be done without the use of tourniquet. Epinephrine is a vasoconstrictor agent that reduces blood flow at surgical site. This bloodless effect is visualized on the skin by a pale color. Thus, WALANT can provide a chemical tourniquet and eliminate the pain from a traditional arm tourniquet. However, this technique is performed with a short-acting LA and does not offer any postoperative analgesia.
The association of TRONC using long-acting LA with the WALANT technique could combine the comfort of a surgery without tourniquet to a long-acting analgesia and thus could provide a superior overall comfort.
The main objective of this prospective, multicentre, randomized, open-label, parallel-group controlled trial is to evaluate the interest of WALANT technique on patient comfort during CTR performed with TRONC, compared to the tourniquet.
This is a multicenter, prospective, randomized, open-label study assessing the interest of the association of the WALANT local infiltration technique with analgesic troncular blocks (TRONC) at the wrist, for the endoscopic CTR.
This study compares two groups:
RA procedures will be systematically performed under ultrasound guidance, 45 min befor surgery. Before each procedure, a skin disinfection will be carried out using an alcoholic iodine solution. The needle approach will be in-plane (IP) or out-of-plane (OOP). Efficiency will be assessed before transfer to the operating room.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CONTROL | Active Comparator | Troncular blocks using a long-acting LA + Tourniquet |
|
| WALANT | Experimental | Troncular blocks using a long-acting LA + WALANT technique using a short-term LA with epinephrine a vasoconstrictor agent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRONC | Procedure | injection of 3 to 7 mL of Ropivacaine 3.75 mg/ml per nerve (median and ulnar nerves) and infiltration of 2 ml of Ropivacaine 3.75 mg/ml laterally above the flexion fold of the wrist in order to block the branches of the lateral cutaneous nerve of the forearm, the terminal sensory branch of the musculocutaneous nerve. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient comfort during CTR | Pain score using a Visual Analogue Sclae (VAS) ranging from 0 to 10 (0= completely painless, 10= extremely painfull). | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of the endoscopic surgical procedure | Numeric Rating Scale (NRS) for visualization during endoscopic surgery ranging from 0 to 5 ( 0=very poor conditions; 5=optimal conditions) | 4 hours |
| Troncular block success |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Jouvenet | Paris | Île-de-France Region | 75016 | France | ||
| Clinique Rémusat |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37031817 | Result | Bloc S, Squara P, Quemeneur C, Doirado M, Thomsen L, Merzoug M, Naudin C, Le Sache F. Wide Awake Local Anesthesia No Tourniquet (WALANT) technique improves the efficiency of distal nerve blocks for carpal tunnel release. Anaesth Crit Care Pain Med. 2023 Aug;42(4):101229. doi: 10.1016/j.accpm.2023.101229. Epub 2023 Apr 7. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014111 | Tourniquets |
| D000077212 | Ropivacaine |
| D008012 | Lidocaine |
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| WALANT | Procedure | infiltration with 3 to 7 ml of 1% lidocaine (10 mg/ml) combined with 0.005 mg/ml epinephrine and 8.4% sodium bicarbonate in the subcutaneous area in front of the transverse ligament, between the thenar and hypothenar eminences, from the flexion fold of the wrist over a length of 5 cm. |
|
| Tourniquet | Procedure | inflation pressure 75 to 100 mmHg above systolic blood pressure. |
|
| Ropivacaine | Drug | troncular blocks with Ropivacaine 3.75 mg/ml |
|
| Lidocaine + Epinephrine | Drug | WALANT technique with 1% lidocaine (10 mg/ml) combined with 0.005 mg/ml epinephrine |
|
Sensory perception to pin-prick on the specific territories of the median, ulnar and radial nerves at 10, 20 and 30 minutes post injection using a 3-point rating: 0 = absence of block (sharp sensation to pinprick), 1 = analgesia (dull sensation to pinprick), 2 = anesthesia (loss of sensation to pinprick)The need for an additional block, an intraoperative surgical infiltration or a sedation will be noted.
| 30 minutes |
| WALANT technique success | Modification (or not) of the skin color near the injection area at 10, 20 and 30 minutes postinjection. | 30 minutes |
| Hemostasis quality for the WALANT group | Usage (or not) of tourniquet. | 4 hours |
| Patient satisfaction | Patient satisfaction score collected in post-anesthesia care unit (PACU) using a Numeric Rating Scale (NRS-Satisfaction) ranging from 0 (very unsatisfied) to 10 (very satisfied). | 4 hours |
| Surgery duration | Time (in minutes) between the skin incision and the last suture. | 4 hours |
| Rate of complications | Incidence of complications related to RA procedure | 20 days |
| Paris |
| Île-de-France Region |
| 75016 |
| France |
| D000814 |
| Aniline Compounds |
| D000588 | Amines |
| D000083 | Acetanilides |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |