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

Forearm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04729868
• Other study ID #: aswu/125/4/17
• Status: Completed
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: October 1, 2020

Study information

• Verified date: January 2021
• Source: Aswan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Deformity of Elbow
• Congenital Abnormalities
• Forearm
• Hand
• Wrist

Intervention

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

Locations

Country	Name	City	State
Egypt	Zaher	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Aswan University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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