Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05864872 |
| Other study ID # |
olfakaabachi |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2023 |
| Est. completion date |
March 1, 2024 |
Study information
| Verified date |
February 2024 |
| Source |
University Tunis El Manar |
| Contact |
OLFA KAABACHI, MD |
| Phone |
216 98317381 |
| Email |
olfa.kaabachi[@]gnet.tn |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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.
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.
