PainNCT05864872
the Best Approach for Blocking Intercostobrachial and Medial Brachial Cutaneous Nerves in the Upper Arm Surgery
A study testing axillary brachial plexus block in people with Pain, run by Olfa kaabachi, MD at 1 site in Tunisia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pain
- What is being tested?
- axillary brachial plexus block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTunisia
- Study dates
- 1 May 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: What is the Best Approach for Blocking Intercostobrachial and Medial Brachial Cutaneous Nerves in the Upper Arm Surgery? Ultrasound as an Alternative to Blind Infiltration
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.
Read more
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.
- Conditions
- Pain
- Being tested
- axillary brachial plexus block
- Keywords
- brachial plexus block, ultrasound, infiltration
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
axillary brachial plexus blockProcedure or surgery
Also called conventional group, ultrasound group
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Procedure: axillary brachial plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
tourniquet pain
The proportion of patients pain free when inflating tourniquet.
Measured: during surgery
Secondary outcomes (4)
sensitive block
The proportion of patients who had no sensation in all 4 regions innervated by both Intercostobrachial and Medial Brachial Cutaneous Nerves
Measured: 5, 10, 15 and 20 minutes after performing the block
rescue sedetion
Proportion of patient with rescue sedation/analgesia because of uncomfortable tourniquet
Measured: during surgery
durationof ultrasound image
time to ultrasound visualisation of both Intercostobrachial and Medial Brachial Cutaneous Nerves
Measured: during ultrasound procedure
Quality of ultrasound images
visualization of the 2 nerves
Measured: during ultrasound procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start1 May 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olfa kaabachi, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Olfa kaabachi, MD, University Tunis El Manar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05864872
- Sponsor's protocol ID
- olfakaabachi
- Status last verified
- Feb 2024
- First submitted
- 8 May 2023
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Best Approach for Blocking Intercostobrachial and Medial Brachial Cutaneous Nerves in the Upper Arm Surgery? Ultrasound as an Alternative to Blind Infiltration
- ClinicalTrials.gov ID
- NCT05864872
- Acronym / sponsor ID
- olfakaabachi
- Conditions
- Pain
- Keywords
- brachial plexus block, ultrasound, infiltration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Olfa kaabachi, MDUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound group | Experimental | Procedure: axillary brachial plexus blockafter 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. |
| conventional group | Active comparator | Procedure: axillary brachial plexus blockafter 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| axillary brachial plexus blockAlso: conventional group, ultrasound groupconventional 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. | Procedure or surgery | Ultrasound group, conventional group |
Primary outcome
tourniquet pain
Time frame: during surgery
The proportion of patients pain free when inflating tourniquet.
4 secondary outcomes
sensitive block
Time frame: 5, 10, 15 and 20 minutes after performing the block
rescue sedetion
Time frame: during surgery
durationof ultrasound image
Time frame: during ultrasound procedure
Quality of ultrasound images
Time frame: during ultrasound procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing axillary brachial plexus block in people with Pain, run by Olfa kaabachi, MD at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tourniquet pain (time frame: during surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.