Brachial Plexus Block Clinical Trial
— ICAXOfficial title:
Comparison of the Infraclavicular and Axillary Approaches for Continuous Ultrasound-guided Brachial Plexus Block: A Prospective Randomized Study
Verified date | March 2023 |
Source | University Hospital, Bordeaux |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Prospective randomized study comparing the axillary and the infraclavicular approaches for continuous brachial plexus block after hand surgery.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | October 2020 |
Est. primary completion date | October 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bordeaux |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Anesthesia score | 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 | 24 hours after block realization | |
Secondary | Duration of catheter insertion procedure | During block realization | ||
Secondary | Maximal pain during the surgery procedure | Measured by patient with numeric scale from 0 = no pain to 10 = maximal pain | During surgery | |
Secondary | Maximal pain during the first 24 hours | Measured by patient with numeric scale from 0 = no pain to 10 = maximal pain | During the first 24 hours after block realization | |
Secondary | Anesthesia score | 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 | 30 minutes after block realization | |
Secondary | Anesthesia score | 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 | 48 hours after block realization | |
Secondary | Total morphine consumption | 24 and 48 hours after block realization | ||
Secondary | Mean pain at rest and with movement | Measured by patient with numeric scale from 0 = no pain to 10 = maximal pain | 24 and 48 hours after block realization | |
Secondary | Quality of sleep | Measured by patient with numeric scale from 0 = insomnia to 10 = excellent sleep | Over first night after block realization | |
Secondary | Patient satisfaction | Measured by patient with numeric scale from 0 = fully unsatisfied to 10 = fully satisfied | 48 hours after block realization |
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