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
Fractures of the forearm bones that occur around the wrist are common in the elderly. Standard anesthesia for its surgical treatment is regional anesthesia (RA): supraclavicular block, infraclavicular block or axillary block (BAX). However, these techniques have some limitations, such as the postoperative pain management and the non-specificity of the analgesia. Indeed analgesia is not specific to the wrist and extends to the elbow and forearm, preventing rapid recovery of elbow flexion and extension when a long-acting local anesthetic (LA) is used. Recently RA techniques associating proximal anesthetic blocks with distal analgesic blocks have been proposed to serve a dual objective: good anesthesia for surgery and specific analgesia.
The hypothesis of this study is that, for the wrist surgery, axillary block using a short-acting LA combined with analgesic blocks at the elbow using a long-acting LA could provide a RA installation time reduction, an optimal surgical comfort, a longer post-operative analgesia duration and a faster recovery from motor block.
This multicenter, prospective, randomized, open-Label study compares two techniques :
Analgesic truncal blocks of the median and radial nerves will be performed at the elbow. 3-7 mL of LA will be injected.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAX | Active Comparator |
| |
| BAX-Asso | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Axillary brachial plexus block with a long-acting local anesthetic | Procedure | axillary block with 15-30 ml Ropivacaine 0,5%. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Level of pain when the patient recovers the flexion of the forearm on the arm | Pain VRS ranging from 0 to 10 (0=no pain, 10=worst possible pain) | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of motor block at the elbow | Time between the performance of regional anesthesia and the elbow flexion recovery | 24 hours |
| Axillary block success | Assess of motor block and sensory perception to pin-prick in the distribution of the five terminal branches at 10, 20, and 30 minutes postinjection. Motor block: complete (2=paralysis), partial (1=paresis), or none (0). Motor function assessed in the following manner: wrist and finger flexion (median nerve), wrist and finger extension (radial nerve), thumb adduction and flexor carpi ulnaris flexion (ulnar nerve), and biceps flexion (musculocutaneous nerve). Sensory block: complete/anesthesia (2=loss of sensation to pinprick), partial/analgesia (1=dull sensation to pinprick), or none (0=sharp sensation to pinprick). Sensory distribution assessed in the following areas: thenar eminence and thumb tip (median nerve), dorsum of hand (radial nerve), fifth digit fingertip (ulnar nerve), lateral aspect of forearm (musculocutaneous nerve) and medial aspect of forearm (medial antebrachial cutaneous nerve). Successful blockade is defined by a sensory-motor score ≥ 3. |
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 du Pré | Le Mans | Pays de la Loire Region | 72018 | France | ||
| Hôpital Privé Paul D'Egine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Axillary brachial plexus block with a short-acting local anesthetic + Analgesic block at the elbow with a long-acting local anesthetic | Procedure | axillary block with 15-30 ml Lidocaine 1,5% + radial and medial nerve block at the elbow with 3-7 ml Ropivacaine 0,5%. |
|
| Ropivacaine | Drug | axillary block with 15-30 ml Ropivacaine 0,5% |
|
| Ropivacaine | Drug | radial and medial nerve block at the elbow with 3-7 ml Ropivacaine 0,5% |
|
| Lidocaine | Drug | axillary block with 15-30 ml Lidocaine 1,5% |
|
| 40 minutes |
| Feasibility of the wrist surgery | Usage (or not) of an additional anesthetic procedure to perform the surgery | 2 hours |
| Duration of postoperative analgesia | Time between the performance of regional anesthesia and the first dose of rescue analgesia with opioides. | 72 hours |
| Postoperative morphine consumption | Cumulated dose of oxynorm (mg) | 48 hours |
| Sleep quality | Incidence of sleep disorders | Day 2 After Surgery |
| Complications during block performance | Incidence of vascular puncture, paresthesia, intraneural injection and intravascular passage | 15 minutes |
| Complications immediately after block | Onset of vertigo, nausea or vomiting | 2 hours |
| Postoperative complications | Questionnaire about potential sensory anomalies such as numbness, itching or tingling | Day 15 After Surgery |
| Champigny-sur-Marne |
| Île-de-France Region |
| 94500 |
| France |
| CMC Ambroise Paré | Neuilly-sur-Seine | Île-de-France Region | 92200 | France |
| Hôpital Privé Armand Brillard | Nogent-sur-Marne | Île-de-France Region | 94130 | France |
| Clinique Bizet | Paris | Île-de-France Region | 75016 | France |
| Clinique Jouvenet | Paris | Île-de-France Region | 75016 | France |
| Clinique Rémusat | Paris | Île-de-France Region | 75016 | France |
| ID | Term |
|---|---|
| D000092503 | Wrist Fractures |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D014954 | Wrist Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D000083 | Acetanilides |
Not provided
Not provided