A Curved Block Needle for the Infraclavicular Brachial Plexus Block

A Curved Block Needle for the Infraclavicular Brachial Plexus Block in Patients Undergoing Surgery Distal to the Elbow

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.

Study Overview

• Status: Completed
• Conditions: Needle Track
• Intervention / Treatment: Device: Curved needle

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Ismailia, Egypt, 41522
    • Suez Canal University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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),

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Curved needle; This will utilize the curved block needle of performance of regional block	Device: Curved needle; In this arm, the curved block needle will be used for regional blockade
No Intervention: Traditional needle; This will utilize the traditional block needle of performance of regional block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance time	The time to perform the Infraclavicular brachial nerve block. Performance time is defined as the sum of recognition time and local anesthetics injection time. Recognition time is defined as the time interval in seconds (s) from needle insertion to achievement of proper motor response. Local anesthetics injection time is defined as the time interval in seconds (s) between the achievement of motor response and the end of local anesthetics injection through the block needle	12 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of needle attempts to elicit proper motor response	New attempt will be defined as needle reinsertions through separate skin puncture.	12 min
Number of needle redirections to elicit proper motor response	Needle redirection will be defined as draw back and redirects the needle if no proper nerve response could be elicited.	12 min
The Infraclavicular brachial nerve block success rate	The Infraclavicular brachial nerve block success will be assessed according to the adequacy of surgical anesthesia and is defined as complete loss of pinprick sensation within 30 min of anesthetic administration and if no supplementation (sedative or analgesic) is required during surgery. Partial block is defined as inadequate sensory blockade after 30 min of anesthetic administration. The supplementation (IV analgesic, rescue blocks or local infiltration) is required to complete the proposed surgery. Failed block is considered if general anesthesia is required to complete the proposed surgery.	30 min after local anesthetics administration
Patient satisfaction	All patients will be asked to rate their discomfort during the block placement and tourniquet pain using the Verbal Rating Scale (VRS: 0 = no discomfort, 10 = the worst discomfort).	during surgical procedures
Anesthesiologist satisfaction	Level of anesthesiologist satisfaction for using different block needles will be evaluated using VRS (0, no satisfaction; 10, maximum satisfaction).	12 min

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events	Incidence of adverse events and complications during and after the procedure will be also recorded. Complications, including hematoma, infection and neuropathies, will be recorded intraoperatively and in the first 48 post-operative hours.	Intraoperative and in the first 48 post-operative hours

Collaborators and Investigators

• Sponsor: Suez Canal University
• Investigators: Study Director: Tarek F. Tammam, Prof., Suez Canal university,Faculty of Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: June 6, 2016
• First Submitted That Met QC Criteria: June 9, 2016
• First Posted (Estimate): June 15, 2016

Study Record Updates

• Last Update Posted (Actual): October 19, 2017
• Last Update Submitted That Met QC Criteria: October 17, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Ultrasound; Regional blockade; Infraclavicular brachial plexus
• Other Study ID Numbers: TFTammam; Ghada A. K (Other Identifier: Suez Canal University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED