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CompletedNCT04729868Updated Jan 29, 2021

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

An interventional study of Levobupivacaine(chirocaine) plus dexmedetomidine(precedex) in Acquired Deformity of Elbow, Forearm and Hand, sponsored by Aswan University Hospital. Completed at 1 site in Egypt. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-01-29.

Sponsored by Aswan University Hospital · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 3 years 9 months after the study started (first participant enrolled Apr 2017, registered Jan 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Acquired Deformity of Elbow
  • Forearm
  • Hand
  • Wrist
03

In context

Congenital Abnormalities

980 studies on the registry are indexed under Congenital Abnormalities; 177 are open to participants now.

This study's enrollment of 60 is above the median of 49 across 491 interventional studies indexed under Congenital Abnormalities.

Browse Congenital Abnormalities studies →

Lead sponsor

Aswan University Hospital is the lead sponsor of 95 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
60 participants (actual)

Study arms

  • 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)

  • 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)

  • 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)

Interventions

  • DrugLevobupivacaine(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

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

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 45 minutes

  2. 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.

    Time frame: 24 hours

  3. 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

    Time frame: 24 hours

  4. 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.

    Time frame: 24 hours

Secondary outcomes

  1. 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)

    Time frame: 24 hours

  2. 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.

    Time frame: 24 hours

  3. 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

    Time frame: 24 hours

  4. 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.

    Time frame: 24 hours

  5. 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.

    Time frame: 24 hours

07

Study locations

1 site
  • Zaher
    Cairo, Egypt
08

References and documents

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. PubMed 36335297 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04729868
Lead sponsor
Aswan University Hospital
Responsible party
Zaher Zaki Zaher (director, Aswan University Hospital) — Principal investigator
First posted
Jan 29, 2021
Start date
Apr 1, 2017
Primary completion
Apr 1, 2020
Completion
Oct 1, 2020
Last update
Jan 29, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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