Clinical trial NCT02799576: A Curved Block Needle for the Infraclavicular Brachial Plexus Block
Official title: A Curved Block Needle for the Infraclavicular Brachial Plexus Block in Patients Undergoing Surgery Distal to the Elbow
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Needle Track
Keywords: Ultrasound
Regional blockade
Infraclavicular brachial plexus
Lead sponsor: Suez Canal University
Sponsor class: OTHER
First posted: 2016-06-15
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesized that using the curved needle could facilitate the block placement and provide short procedure time. Aim of the work: The investigators will compare namely straight and curved block needle with in-plane needle insertion techniques for the infraclavicular brachial plexus nerve block (ICNB) regarding the block performance time.

Detailed description: Sometimes, there is a limited block needle access at the inferior edge of the clavicle while performing in- plane infraclavicular parasagittal blockade. This might present a challenge in manipulating and visualizing the block needle in easy way along its entire trajectory during the blockade. The curved block needle might have its positive impact on the capacity to control the block needle advancement relative to the target nerve.

70 patients between the ages of 18 and 60 years with American Society of Anesthesiologists (ASA) physical status I- II, scheduled for elective surgery distal to the elbow will be enrolled in a prospective, comparative, randomized clinical study.

Patients will be randomly assigned into two groups: C (n = 35), in whom US-guided single injection ICNB will be performed using a curved line needle; and S (n = 35), in whom US-guided ICNB will be performed using a straight line needle. All patients will be pre-medicated with oral diazepam (7.5 mg) 30 min before the procedure, and IV fentanyl (50 ug) will be administered 5 minutes before placement of the block. Before the procedure, an IV access and standard monitoring of electrocardiogram (ECG), noninvasive blood pressure (NIBP), and peripheral oxygen saturation (SPO2) will be established.

The ultrasound guided Infraclavicular brachial plexus block will be performed in the block room using a linear-array US probe (8-13 MHz). The ultrasound probe will be placed just below the lower edge of the clavicle and medial to the coracoid process (parasagittal orientation), with adjustment of depth, frequency and gain to spot the best view of the transverse axillary artery and its surrounding cords (short-axis view).

After sterile skin preparation with chlorhexidine solution, local infiltration with 2 ml of lidocaine (10 mg/ml) will be made at the cephalad aspect of the ultrasound probe. A 10-cm, short-bevel block (straight or curved) needle will be attached to the nerve stimulator delivering a current of 1.2 mA ( milliampere) at a frequency of 2 Hz (Hertz), will be inserted in-plane just inferior to the clavicle.

After eliciting the posterior cord motor response (finger or wrist extension) with a current intensity of ≤ 0.5 mA, correct needle-tip position will be confirmed by test injections with 1 ml of 5 % dextrose solution. Then, thirty milliliters of local anesthetic mixture (lidocaine 10 mg/ml and bupivacaine 2.5 mg/ml) will be incrementally injected after careful aspiration. The goal is to ensuring a U-shaped distribution of anaesthetic solution with anterior displacement of the axillary artery.

Eligibility criteria: Inclusion Criteria:

* 18 - 60 year old both sex, able to provide informed consent to participate, enrolled in elective surgery distal to the elbow, single procedure.

Exclusion Criteria:

* Unable to consent to participate, known to have lidocaine or bupivacaine allergy, more than one procedure will be performed at the same setting, patients with local infections,neuropathies, coagulopathies,and history of chronic analgesic therapy, Obesity (body mass index ≥ 30 kg/m2),

Primary outcomes:
measure: Performance time
timeFrame: 12 min
Secondary outcomes:
measure: Number of needle attempts to elicit proper motor response
timeFrame: 12 min
measure: Number of needle redirections to elicit proper motor response
timeFrame: 12 min
measure: The Infraclavicular brachial nerve block success rate
timeFrame: 30 min after local anesthetics administration
measure: Patient satisfaction
timeFrame: during surgical procedures
measure: Anesthesiologist satisfaction
timeFrame: 12 min
Other outcomes:
measure: Incidence of adverse events
timeFrame: Intraoperative and in the first 48 post-operative hours
Locations:
city: Ismailia
country: Egypt
facility: Suez canal University hospital
Study officials:
affiliation: Suez Canal university,Faculty of Medicine
name: Tarek F. Tammam, Prof.
role: STUDY_DIRECTOR
References:
citation: Tammam TF, Kamhawy GA. Use of a curved needle to facilitate lateral sagittal infraclavicular block performance: a randomized clinical trial. J Anesth. 2019 Oct;33(5):604-611. doi: 10.1007/s00540-019-02674-w. Epub 2019 Aug 29.