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

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

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

Study Overview

• Status: Withdrawn
• Conditions: Brachial Plexus Block; Anesthesia, Regional
• Intervention / Treatment: Procedure: Hand surgery under regional anesthesia

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • CHU de Bordeaux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Axillary block group; Initial bolus will be given and then a perinervous catheter will be inserted by the axillary approach.	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.
Experimental: Infraclavicular block group; Initial bolus will be given and then a perinervous catheter will be inserted by the infraclavicular approach.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of catheter insertion procedure		During block realization
Maximal pain during the surgery procedure	Measured by patient with numeric scale from 0 = no pain to 10 = maximal pain	During surgery
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
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
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
Total morphine consumption		24 and 48 hours after block realization
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
Quality of sleep	Measured by patient with numeric scale from 0 = insomnia to 10 = excellent sleep	Over first night after block realization
Patient satisfaction	Measured by patient with numeric scale from 0 = fully unsatisfied to 10 = fully satisfied	48 hours after block realization

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2019
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): October 1, 2020

Study Registration Dates

• First Submitted: August 7, 2019
• First Submitted That Met QC Criteria: August 7, 2019
• First Posted (Actual): August 12, 2019

Study Record Updates

• Last Update Posted (Actual): March 17, 2023
• Last Update Submitted That Met QC Criteria: March 15, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Brachial Plexus Block; Anesthesia, Regional; Hand surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: CHUBX 2019/04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No