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Completed

NCT Number: NCT04729868

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.

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zaher

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levobupivacaine(chirocaine) plus dexmedetomidine(precedex)

Drug

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

Primary outcomes

  1. Onset time of sensory block in minutes

    Time frame: 45 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).

  2. onset time of motor blockade in minutes using the modified Bromage scale (Three-point scale)

    Time frame: 24 hours

    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.

  3. Duration of sensory block in hours

    Time frame: 24 hours

    It's the time from sensory block onset to the time of restoration of sensation at the surgical site

  4. Duration of motor block in hours

    Time frame: 24 hours

    It's the time from motor block onset to the restoration of global mobility in the hand and the wrist.

Secondary outcomes

  1. Visual analog scale (VAS)

    Time frame: 24 hours

    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)

  2. Postoperative first analgesic request time in hours

    Time frame: 24 hours

    was taken from the time of complete sensory block to the request to rescue analgesia when VAS > 4 cm.

  3. Mean blood pressure in mmHg

    Time frame: 24 hours

    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

  4. heart rate in beats / minute

    Time frame: 24 hours

    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.

  5. peripheral oxygen saturation

    Time frame: 24 hours

    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.

Sponsors and collaborators

Lead sponsor

Aswan University Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jan 29, 2021
Registry last updated
Jan 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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