Ultrasound Guided Infraclavicular Brachial Plexus Block Using Levo-bupivacaine Alone or Combined With Dexmedetomidine for Hand and Forearm Surgeries

To evaluate the efficacy of levo-bupivacaine alone and with dexmedetomidine in Ultrasound guided infraclavicular brachial plexus block for hand and forearm surgeries as regard:

Onset of sensory and motor blockade. Duration of sensory and motor blockade.

Analgesic pain scores using the verbal rating scale (VRS) for pain. Duration of analgesia postoperative complications.

Study Overview

• Status: Completed
• Conditions: Forearm; Hand; Wrist; Acquired Deformity of Elbow
• Intervention / Treatment: Drug: Levobupivacaine(chirocaine) plus dexmedetomidine(precedex)

Detailed Description

Technique for ultrasound guided infraclavicular brachial plexus block:

Preliminary scan

• The patient is positioned supine with the arm abducted to 90°(or resting by their side if unable to do so).
• The probe is placed immediately medial to the coracoid process in the parasagittal plane.
• Identify the pectoralis major and minor muscles superficially and the axillary artery and vein(s) deep to this. The vein is usually caudad relative to the artery.
• The cords of the brachial plexus are seen as either hypoechoic or hyperechoic structures positioned around the axillary artery. The lateral cord is lateral (cephalad) to the artery, the medial cord medial (caudad),and the posterior cord posterior (deep). They can be difficult to visualize but are usually positioned closely to the artery.

Ultrasound settings

• Probe: high-frequency (>10MHz) linear broadband probe.
• Settings: MB-resolution/general.
• Depth: 3-6cm.
• Orientation: parasagittal.
• Needle: 50-100mm depending on depth of plexus. Technique
• An in-plane approach is recommended, inserted from the cephalad end of the transducer.
• Needle tip visualization may be challenging as the needle angle can be quite steep.
• Prepare the skin with 0.5% chlorhexidine in 70% alcohol. Wait until the skin is dry.
• Anaesthetize the skin with a subcutaneous injection of 1% lidocaine at the point of needle insertion.
• The needle is first advanced posterolateral to the artery to deposit local anesthetic around the posterior cord, 5 o'clock position on artery.
• After careful aspiration LA is injected in small aliquots, observing the spread of the LA which ideally occurs behind and up both sides of the artery forming a 'U' shape around the artery, 1-9 o'clock around the artery.
• If medial (caudad) spread is not observed then reinsertion of the needle between the axillary artery and vein, adjacent to the medial cord may be required.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Zaher

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age: 20-65 years old.
• American society of anesthesiologist physical status (ASA): I-II.
• Operation: forearm & hand surgeries.

Exclusion Criteria:

• Patients with chronic pain
• Those using chronic analgesic medications
• History of brachial plexus injury
• Allergy to the study drugs
• Hepatic or renal insufficiency or infection at the site of injection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: group Levo-bupivacaine; Group A (20 patients): Anesthesia will be performed with 35 ml of 0.5% levo-bupivacaine plus 1ml normal saline under the guidance of ultrasound for infraclavicular brachial plexus block.	Drug: Levobupivacaine(chirocaine) plus dexmedetomidine(precedex); evaluate the efficacy of levo-bupivacaine alone and with dexmedetomidine in Ultrasound guided infraclavicular brachial plexus block for hand and forearm surgeries; Other Names: the efficacy of levo-bupivacaine alone and with dexmedetomidine in Ultrasound guided infraclavicular brachial plexus block for hand and forearm surgeries
OTHER: group levo-bupivacaine plus 50µg dexmedetomidine; Group B (20 patients): Anesthesia will be performed with 35 ml of 0.5% levo-bupivacaine plus 50µg dexmedetomidine under the guidance of ultrasound for infraclavicular brachial plexus block.	Drug: Levobupivacaine(chirocaine) plus dexmedetomidine(precedex); evaluate the efficacy of levo-bupivacaine alone and with dexmedetomidine in Ultrasound guided infraclavicular brachial plexus block for hand and forearm surgeries; Other Names: the efficacy of levo-bupivacaine alone and with dexmedetomidine in Ultrasound guided infraclavicular brachial plexus block for hand and forearm surgeries
OTHER: group levo-bupivacaine plus 100µg dexmedetomidine; Group C (20 patients): Anesthesia will be performed with 35 ml of 0.5% levo-bupivacaine plus 100µg dexmedetomidine under the guidance of ultrasound for infraclavicular brachial plexus block.	Drug: Levobupivacaine(chirocaine) plus dexmedetomidine(precedex); evaluate the efficacy of levo-bupivacaine alone and with dexmedetomidine in Ultrasound guided infraclavicular brachial plexus block for hand and forearm surgeries; Other Names: the efficacy of levo-bupivacaine alone and with dexmedetomidine in Ultrasound guided infraclavicular brachial plexus block for hand and forearm surgeries

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Onset time of sensory block in minutes	After the injection of the solution, every patient was checked for the onset of sensory blockade using goose soaked with iced normal saline by the following scale (three-point scale): Grade 0= perceived as normal sensation, Grade 1 = loss of cold sensation (analgesia), Grade 2= loss of sensation of touch (anesthesia).	45 minutes
onset time of motor blockade in minutes using the modified Bromage scale (Three-point scale)	the modified Bromage scale (Three-point scale): Grade 0: Normal motor function, Grade 1: Decreased motor strength with the ability to move the fingers only, Grade 2: Complete motor block with an inability to move the fingers.	24 hours
Duration of sensory block in hours	It's the time from sensory block onset to the time of restoration of sensation at the surgical site	24 hours
Duration of motor block in hours	It's the time from motor block onset to the restoration of global mobility in the hand and the wrist.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analog scale (VAS)	the VAS consisted of a straight, vertical 10-cm line; the bottom point represented "no pain" = (0 cm) and the top "the worst pain you ever have" = (10 cm)	24 hours
Postoperative first analgesic request time in hours	was taken from the time of complete sensory block to the request to rescue analgesia when VAS > 4 cm.	24 hours
Mean blood pressure in mmHg	was measured before the block (0 min) and at 5, 10, 15, 30 min then 1, 2, 3, 6, 12,18and 24 h after the block	24 hours
heart rate in beats / minute	was measured before the block (0 min) and at 5, 10, 15, 30 min then 1, 2, 3, 6, 12,18and 24 h after the block.	24 hours
peripheral oxygen saturation	was measured before the block (0 min) and at 5, 10, 15, 30 min then 1, 2, 3, 6, 12,18and 24 h after the block.	24 hours

Collaborators and Investigators

• Sponsor: Aswan University Hospital

Publications and helpful links

General Publications

• Ghazaly HF, Aly AAA, Zaher ZZ, Hassan MM, Mahmoud AA. Comparison of the efficacy of two doses of dexmedetomidine as an adjunct to levobupivacaine in infraclavicular brachial plexus block: prospective double-blinded randomized controlled trial. BMC Anesthesiol. 2022 Nov 5;22(1):338. doi: 10.1186/s12871-022-01858-4.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2017
• Primary Completion (ACTUAL): April 1, 2020
• Study Completion (ACTUAL): October 1, 2020

Study Registration Dates

• First Submitted: January 7, 2021
• First Submitted That Met QC Criteria: January 27, 2021
• First Posted (ACTUAL): January 29, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 29, 2021
• Last Update Submitted That Met QC Criteria: January 27, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Anesthetics, Local; Dexmedetomidine; Bupivacaine; Levobupivacaine
• Other Study ID Numbers: aswu/125/4/17

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No