Comparison of the Infraclavicular and Axillary Approaches for Continuous Ultrasound-guided Brachial Plexus Block. (ICAX)

University Hospital of Bordeaux

Status

Withdrawn

Conditions

Anesthesia, Regional

Brachial Plexus Block

Treatments

Procedure: Hand surgery under regional anesthesia

Study type

Interventional

Funder types

Other

Identifiers

NCT04053491

CHUBX 2019/04

Details and patient eligibility

About

Prospective randomized study comparing the axillary and the infraclavicular approaches for continuous brachial plexus block after hand surgery.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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