Comparison of the Infraclavicular and Axillary Approaches for Continuous Ultrasound-guided Brachial Plexus Block.
- Conditions
- Brachial Plexus BlockAnesthesia, Regional
- Interventions
- Procedure: Hand surgery under regional anesthesia
- Registration Number
- NCT04053491
- Lead Sponsor
- University Hospital, Bordeaux
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Axillary block group Hand surgery under regional anesthesia Initial bolus will be given and then a perinervous catheter will be inserted by the axillary approach. Infraclavicular block group Hand surgery under regional anesthesia Initial bolus will be given and then a perinervous catheter will be inserted by the infraclavicular approach.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Anesthesia score 48 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
Total morphine consumption 24 and 48 hours after block realization 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
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
Maximal pain during the surgery procedure During surgery Measured by patient with numeric scale from 0 = no pain to 10 = maximal pain