Anesthesia, Regional, Brachial Plexus Block
Conditions
Keywords
Hand surgery, Anesthesia, Regional, Brachial Plexus Block
Brief summary
Prospective randomized study comparing the axillary and the infraclavicular approaches for continuous brachial plexus block after hand surgery.
Detailed description
Regional anesthesia is considered as the gold standard for analgesia and anesthesia of hand surgeries. However, with a single-shot technique, a maximum of 13 hours of analgesia is obtained, even with a long-acting local anesthetic and adjuvants. For painful surgeries necessitating prolonged analgesia of more than 24 hours, continuous regional analgesia techniques have been described, using perinervous catheters. However, these techniques have a high incidence of failure. The most frequent causes of failure are catheter displacements, misplacement, and the distance between the targeted nerves. Many approaches have been described to insert these catheters (axillary, infraclavicular and supraclavicular), but the optimal approach remains unknown. Therefore, international and even local practices vary widely. Investigators plan to compare the axillary and the infraclavicular approaches in this randomized study, on 60 patients. In every group, an initial bolus will be given and then a perinervous catheter will be inserted by the allocated approach. The surgery will be done under regional anesthesia. The co-analgesia, the local anesthetic infusion and the follow-up will be standardized and will be the same in the two groups. The primary outcome will be an anesthesia score on 16 points previously described in other similar publication. The primary outcome will be at 24 hours after block realization, but it will be repeated at 48 hours. It will evaluate the degree of sensitive and motor blockade of every major nerve of the hand. Secondary outcomes will be the time, comfort and adverse effects of the technique, and postoperative pain, analgesia, satisfaction and adverse effects. The aim of this study is to help determine the optimal approach for brachial plexus catheter insertion, in order to improve analgesia, to decrease morphine consumption and its related adverse effects, and to improve patients and caregivers satisfaction.
Interventions
PROCEDUREHand surgery under regional anesthesia
In both groups, patients will benefit from an initial standardized bolus (long-acting local anesthetic, ropivacaine) to cover the operative period, via the allocated approach. Ultrasound guidance and the recommended standards monitors will be used in both groups. After the initial bolus, a catheter will be inserted via the allocated approach. Surgery will be done under regional anesthesia alone, unless there is a medical contraindication or if the patient asks for general anesthesia. Post-operative analgesia will be standardized with regular paracetamol, regular NSAID (Nonsteroidal anti-inflammatory drugs) and oxycodone if needed. The local anesthetics perfusion will be standardized. There will be a medical follow up at 24 and 48 hours where data will be collected.
Sponsors
University Hospital, Bordeaux
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients with a social insurance number * ASA 1-3 * Patients undergoing hand surgery requiring a continuous brachial plexus block * Elective or urgent surgery * Effective contraception (HAS criteria) * Informed consent
Exclusion criteria
* Contraindication to the installation of a continuous brachial plexus block (coagulopathy, refusal, allergy to the medication) * Preexisting neuropathy * Pregnancy * Arteriovenous fistula * Obesity (BMI \>40) * Another surgical site implicated during the surgery * Incapacity to abduct the operated arm * Preoperative use of morphine or equivalent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anesthesia score | 24 hours after block realization | Min/Max : 0 for no anesthesia to 16 total anesthesia Addition of Motor block score (0-2) and Sensitive block score (0-2) for the 4 main nerves of the hand |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximal pain during the surgery procedure | During surgery | Measured by patient with numeric scale from 0 = no pain to 10 = maximal pain |
| Maximal pain during the first 24 hours | During the first 24 hours after block realization | Measured by patient with numeric scale from 0 = no pain to 10 = maximal pain |
| Anesthesia score | 30 minutes after block realization | Min/Max : 0 for no anesthesia to 16 total anesthesia Addition of Motor block score (0-2) and Sensitive block score (0-2) for the 4 main nerves of the hand |
| Duration of catheter insertion procedure | During block realization | — |
| Mean pain at rest and with movement | 24 and 48 hours after block realization | Measured by patient with numeric scale from 0 = no pain to 10 = maximal pain |
| Quality of sleep | Over first night after block realization | Measured by patient with numeric scale from 0 = insomnia to 10 = excellent sleep |
| Patient satisfaction | 48 hours after block realization | Measured by patient with numeric scale from 0 = fully unsatisfied to 10 = fully satisfied |
| Total morphine consumption | 24 and 48 hours after block realization | — |
Outcome results
None listed