A Curved Block Needle for the Infraclavicular Brachial Plexus Block

NCT ID: NCT02799576

Last Updated: 2017-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2017-10-31

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.

Conditions

Needle Track

Keywords

Ultrasound; Regional blockade; Infraclavicular brachial plexus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Curved needle

This will utilize the curved block needle of performance of regional block

Group Type: EXPERIMENTAL

Curved needle

Intervention Type: DEVICE

In this arm, the curved block needle will be used for regional blockade

Traditional needle

This will utilize the traditional block needle of performance of regional block

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Curved needle

In this arm, the curved block needle will be used for regional blockade

Intervention Type: DEVICE

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),

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suez Canal University

OTHER

Sponsor Role: lead

Responsible Party

Tarek F.Tammam

Prof. of anesthesia and intensive care,faculty of medicine,Suez Canal University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tarek F. Tammam, Prof.

Role: STUDY_DIRECTOR

Suez Canal university,Faculty of Medicine

Locations

Suez canal University hospital

Ismailia, , Egypt

Countries

Egypt

References

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.

Reference Type: DERIVED

PMID: 31468177 (View on PubMed)

Other Identifiers

Ghada A. K

Identifier Type: OTHER

Identifier Source: secondary_id

TFTammam

Identifier Type: -

Identifier Source: org_study_id