NCT05864872

Brief Summary

Brachial plexus block (BPB) alone, whether performed at the axilla or more proximally, does not provide sufficient anesthesia for the skin of the medial upper arm and elbow, because thoracic roots contribute to the innervation of these areas. For surgery of the upper arm, the brachial plexus block needs to be completed by the Medial Brachial Cutaneous nerve (MBCN) and the Intercostobrachial nerve (ICBN) nerve blocks. The ICBN is not part of the brachial plexus; it usually originates from the lateral branch of the second intercostals nerve (T2). The MBCN and the ICBN are often interconnected. In the axilla, they are separated from the brachial plexus by the brachial fascia. Therefore, when an axillary brachial plexus block (ABPB) is performed, the local anesthetic solution may be prevented from spreading toward the MBCN and ICBN. These nerves are classically anesthetized by raising a subcutaneous wheel of local anesthetic spanning the entire width of the medial aspect of the arm at the level of the axilla, usually from anteriorly to posteriorly. The failure rate of this blind infiltration procedure has never been quantified in the literature. Traditional teaching suggests that the ICBN should be blocked to prevent tourniquet pain. Lanz et al (1) showed that BPB, whether performed to the axilla or more proximally, rarely extend to the ICBN (10% of cases). However, recent literature shows differences in opinion on the role of an ICBN/MBCN blocks in preventing tourniquet pain. Ultrasound guided ABPB is sufficient to provide anaesthesia for tourniquet even during prolonged ischemia. However, to ensure prevention of tourniquet discomfort a multiple injection technique that include musculocutaneous blockade should be preferred (2). The overall incidence of tourniquet pain in the setting of an effectively dense supraclavicular brachial plexus block for surgical anesthesia was low, even without the addition of an ICBN block. This tourniquet pain can be easily managed with small increases in systemic analgesics (3). However, in Magazzeni Ph et al (4) study, ultrasound-Guided Block of ICBN and MBCN was associated to a better sensory block and a less painful tourniquet compared to conventional block. The optimal access for an ultrasound guided block of the MBCN and the ICBN nerves is not yet known.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2023

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 8, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 18, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

December 24, 2025

Status Verified

February 1, 2024

Enrollment Period

1.2 years

First QC Date

May 8, 2023

Last Update Submit

December 17, 2025

Conditions

Keywords

brachial plexus blockultrasoundinfiltration

Outcome Measures

Primary Outcomes (1)

  • tourniquet pain

    The proportion of patients pain free when inflating tourniquet.

    during surgery

Secondary Outcomes (4)

  • sensitive block

    5, 10, 15 and 20 minutes after performing the block

  • rescue sedetion

    during surgery

  • durationof ultrasound image

    during ultrasound procedure

  • Quality of ultrasound images

    during ultrasound procedure

Study Arms (2)

Ultrasound group

EXPERIMENTAL

after blockage of the principal four nerves of the brachial plexus, the needle was redirected, and between 1 and 2 mL of bupivacaine was injected around each visible nerve branch (Intercostobrachial and Medial Brachial Cutaneous ); if the nerve branches were not visible, 5 mL of the local anesthetic was injected (or less volume if the nerves appeared during the injection), in the subcutaneous area located above the brachial fascia, with a posterior direction, toward the latissimus dorsi muscle.

Procedure: axillary brachial plexus block

conventional group

ACTIVE COMPARATOR

after blockage of the principal four nerves of the brachial plexus, 3 to 6 mL of bupivacaine (at the discretion of the anesthesiologist) was infiltrated blindly subcutaneously at the same level of the axilla in the anteroposterior direction prior to complete needle withdrawal

Procedure: axillary brachial plexus block

Interventions

conventional group, 3 to 6 mL of bupivacaine was infiltrated blindly subcutaneously at the same level of the axilla in the anteroposterior direction prior ultrasound group:1 and 2 mL of bupivacaine was injected around each visible nerve branch (Intercostobrachial and Medial Brachial Cutaneous ); if the nerve branches were not visible, 5 mL of the local anesthetic was injected in the subcutaneous area located above the brachial fascia, with a posterior direction, toward the latissimus dorsi muscle.

Also known as: conventional group, ultrasound group
Ultrasound groupconventional group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient belonged to (ASA) physical status 1 2 3, aged more than 18 years old and scheduled for surgery of the upper limb (hand, forearm, elbow, and anteromedial and posteromedial arm).

You may not qualify if:

  • Patients refusal, any allergy to the study drugs, local infection at any of the puncture sites, any coagulation disorder, or any neurological or psychological problem which may have affected proper subjective interpretation of the results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KAABACHI

Tunis, 2010, Tunisia

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 8, 2023

First Posted

May 18, 2023

Study Start

May 1, 2023

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

December 24, 2025

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations