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

NCT ID: NCT04729868

Last Updated: 2021-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2020-10-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acquired Deformity of Elbow Forearm Hand Wrist

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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.

Group Type OTHER

Levobupivacaine(chirocaine) plus dexmedetomidine(precedex)

Intervention Type DRUG

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

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.

Group Type OTHER

Levobupivacaine(chirocaine) plus dexmedetomidine(precedex)

Intervention Type DRUG

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

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.

Group Type OTHER

Levobupivacaine(chirocaine) plus dexmedetomidine(precedex)

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aswan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zaher Zaki Zaher

director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zaher

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type DERIVED
PMID: 36335297 (View on PubMed)

Other Identifiers

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aswu/125/4/17

Identifier Type: -

Identifier Source: org_study_id