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

Primary Purpose

Acquired Deformity of Elbow, Forearm, Hand

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Levobupivacaine(chirocaine) plus dexmedetomidine(precedex)
Sponsored by
Aswan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Acquired Deformity of Elbow

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zaher

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

group Levo-bupivacaine

group levo-bupivacaine plus 50µg dexmedetomidine

group levo-bupivacaine plus 100µg dexmedetomidine

Arm Description

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 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 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.

Outcomes

Primary Outcome Measures

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).
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.
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
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.

Secondary Outcome Measures

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)
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.
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
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.
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.

Full Information

First Posted
January 7, 2021
Last Updated
January 27, 2021
Sponsor
Aswan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04729868
Brief Title
Ultrasound Guided Infraclavicular Brachial Plexus Block Using Levo-bupivacaine Alone or Combined With Dexmedetomidine for Hand and Forearm Surgeries
Official Title
Ultrasound Guided Infraclavicular Brachial Plexus Block Using Levo-bupivacaine Alone or Combined With Dexmedetomidine for Hand and Forearm Surgeries
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
October 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aswan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Deformity of Elbow, Forearm, Hand, Wrist

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group Levo-bupivacaine
Arm Type
Other
Arm Description
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.
Arm Title
group levo-bupivacaine plus 50µg dexmedetomidine
Arm Type
Other
Arm Description
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.
Arm Title
group levo-bupivacaine plus 100µg dexmedetomidine
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Levobupivacaine(chirocaine) plus dexmedetomidine(precedex)
Other Intervention Name(s)
the efficacy of levo-bupivacaine alone and with dexmedetomidine in Ultrasound guided infraclavicular brachial plexus block for hand and forearm surgeries
Intervention Description
evaluate the efficacy of levo-bupivacaine alone and with dexmedetomidine in Ultrasound guided infraclavicular brachial plexus block for hand and forearm surgeries
Primary Outcome Measure Information:
Title
Onset time of sensory block in minutes
Description
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
Title
onset time of motor blockade in minutes using the modified Bromage scale (Three-point scale)
Description
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
Title
Duration of sensory block in hours
Description
It's the time from sensory block onset to the time of restoration of sensation at the surgical site
Time Frame
24 hours
Title
Duration of motor block in hours
Description
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 Outcome Measure Information:
Title
Visual analog scale (VAS)
Description
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
Title
Postoperative first analgesic request time in hours
Description
was taken from the time of complete sensory block to the request to rescue analgesia when VAS > 4 cm.
Time Frame
24 hours
Title
Mean blood pressure in mmHg
Description
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
Title
heart rate in beats / minute
Description
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
Title
peripheral oxygen saturation
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Zaher
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
36335297
Citation
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.
Results Reference
derived

Learn more about this trial

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

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