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

Brachial Plexus Block Clinical Trial

— ICAX  

Official title:

Comparison of the Infraclavicular and Axillary Approaches for Continuous Ultrasound-guided Brachial Plexus Block: A Prospective Randomized Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04053491
• Other study ID #: CHUBX 2019/04
• Status: Withdrawn
• Phase: N/A
• Start date: September 2019
• Est. completion date: October 2020

Study information

• Verified date: March 2023
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• 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

Related Conditions & MeSH terms

• Anesthesia, Regional
• Brachial Plexus Block

Intervention

Procedure:
• Hand 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Outcome

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