Clinical trial NCT04053491: Comparison of the Infraclavicular and Axillary Approaches for Continuous Ultrasound-guided Brachial Plexus Block.
Official title: Comparison of the Infraclavicular and Axillary Approaches for Continuous Ultrasound-guided Brachial Plexus Block: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Anesthesia, Regional
Brachial Plexus Block
Keywords: Hand surgery
Anesthesia, Regional
Brachial Plexus Block
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2019-08-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Anesthesia score
timeFrame: 24 hours after block realization
Secondary outcomes:
measure: Duration of catheter insertion procedure
timeFrame: During block realization
measure: Maximal pain during the surgery procedure
timeFrame: During surgery
measure: Maximal pain during the first 24 hours
timeFrame: During the first 24 hours after block realization
measure: Anesthesia score
timeFrame: 30 minutes after block realization
measure: Anesthesia score
timeFrame: 48 hours after block realization
measure: Total morphine consumption
timeFrame: 24 and 48 hours after block realization
measure: Mean pain at rest and with movement
timeFrame: 24 and 48 hours after block realization
measure: Quality of sleep
timeFrame: Over first night after block realization
measure: Patient satisfaction
timeFrame: 48 hours after block realization
Other outcomes:
Locations:
Study officials:
References: