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CompletedNCT05864872Updated Dec 24, 2025

the Best Approach for Blocking Intercostobrachial and Medial Brachial Cutaneous Nerves in the Upper Arm Surgery

An interventional study of axillary brachial plexus block in Pain, sponsored by Olfa kaabachi, MD. Completed at 1 site in Tunisia. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-12-24.

Sponsored by Olfa kaabachi, MD · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the detailed description
  • Routine monitoring was applied, and intravenous access secured for each patient.
  • Sedation with 2 mg of midazolam was administrated
  • 2L of O2 were administrated through nasal cannula
  • Physical separation between the patient and the anesthesiologist was established before the block procedure
  • Ultrasound images were acquired with SonoSite(Turbo M), and a linear ultrasound probe (6-13 MHz) was used.
  • Nerve blocks were performed with 100mm 22-gauge needles (Braun), in an awake patient through ideally a single skin puncture.
  • In both groups, the median, radial, ulnar, musculocutaneous, and medial antebrachial cutaneous nerves were blocked with a total of 30 mL of a mixiture of 0.5 %bupivacaine + 1% lilocaine
  • Intraoperatively, if the tourniquet was painful, fentanyl and additional midazolam dose were administered.

Patients are allocated to one of the two groups:

Group C In patients allocated to the conventional group, 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.

Group U In patients allocated to the USG group, the needle was redirected, and between 1 and 2 mL of bupivacaine was injected around each visible nerve branch (MBCN and ICBN); 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.

02

Conditions studied

  • Pain

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Keywords

  • brachial plexus block
  • ultrasound
  • infiltration
03

In context

Pain

2,226 studies on the registry are indexed under Pain; 917 are open to participants now.

This study's enrollment of 140 is above the median of 70 across 1,911 interventional studies indexed under Pain.

Browse Pain studies →

Lead sponsor

Olfa kaabachi, MD is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
140 participants (actual)

Study arms

  • Experimental
    Ultrasound group

    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

  • Active comparator
    conventional group

    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

  • Procedureaxillary brachial plexus block

    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

06

What researchers measure

Primary outcomes

  1. tourniquet pain

    The proportion of patients pain free when inflating tourniquet.

    Time frame: during surgery

Secondary outcomes

  1. sensitive block

    The proportion of patients who had no sensation in all 4 regions innervated by both Intercostobrachial and Medial Brachial Cutaneous Nerves

    Time frame: 5, 10, 15 and 20 minutes after performing the block

  2. rescue sedetion

    Proportion of patient with rescue sedation/analgesia because of uncomfortable tourniquet

    Time frame: during surgery

  3. durationof ultrasound image

    time to ultrasound visualisation of both Intercostobrachial and Medial Brachial Cutaneous Nerves

    Time frame: during ultrasound procedure

  4. Quality of ultrasound images

    visualization of the 2 nerves

    Time frame: during ultrasound procedure

07

Study locations

1 site
  • KAABACHI
    Tunis, 2010, Tunisia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05864872
Lead sponsor
Olfa kaabachi, MD
Responsible party
Olfa kaabachi, MD (MD, University Tunis El Manar) — Sponsor-investigator
First posted
May 18, 2023
Start date
May 1, 2023
Primary completion
Jun 30, 2024
Completion
Jun 30, 2024
Last update
Dec 24, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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