Acquired Deformity of ElbowNCT04729868

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

A study testing Levobupivacaine(chirocaine) plus dexmedetomidine(precedex) in people with Acquired Deformity of Elbow and Forearm, run by Aswan University Hospital at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 20 to 65 years
Conditions the study is for: Acquired Deformity of Elbow, Forearm, Hand
What is being tested?: Levobupivacaine(chirocaine) plus dexmedetomidine(precedex)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteEgypt
Study dates: 1 Apr 2017to 1 Oct 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Zaher
Cairo

Other trials in Egypt

About this study

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.

Conditions: Acquired Deformity of Elbow, Forearm, Hand, Wrist
Being tested: Levobupivacaine(chirocaine) plus dexmedetomidine(precedex)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Levobupivacaine(chirocaine) plus dexmedetomidine(precedex)Drug
Also called the efficacy of levo-bupivacaine alone and with dexmedetomidine in Ultrasound guided infraclavicular brachial plexus block for hand and forearm surgeries
evaluate the efficacy of levo-bupivacaine alone and with dexmedetomidine in Ultrasound guided infraclavicular brachial plexus block for hand and forearm surgeries

Study groups in NCT04729868
Study group	Role	What they receive
group Levo-bupivacaine	Other	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. Receives: Drug: Levobupivacaine(chirocaine) plus dexmedetomidine(precedex)
group levo-bupivacaine plus 50µg dexmedetomidine	Other	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. Receives: Drug: Levobupivacaine(chirocaine) plus dexmedetomidine(precedex)
group levo-bupivacaine plus 100µg dexmedetomidine	Other	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. Receives: Drug: Levobupivacaine(chirocaine) plus dexmedetomidine(precedex)

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 45 minutes
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.
Measured: 24 hours
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
Measured: 24 hours
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.
Measured: 24 hours

Secondary outcomes (5)

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)
Measured: 24 hours
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.
Measured: 24 hours
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
Measured: 24 hours
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.
Measured: 24 hours
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.
Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 20171 Oct 2020

First posted29 Jan 2021
Study start1 Apr 2017
Primary completion1 Apr 2020
Study completion1 Oct 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Acquired Deformity of ElbowStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04729868
Sponsor's protocol ID: aswu/125/4/17
Status last verified: Jan 2021
First submitted: 7 Jan 2021
Last updated: 29 Jan 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

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

Study at a glance

From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ultrasound Guided Infraclavicular Brachial Plexus Block Using Levo-bupivacaine Alone or Combined With Dexmedetomidine for Hand and Forearm Surgeries
ClinicalTrials.gov ID: NCT04729868
Acronym / sponsor ID: aswu/125/4/17
Conditions: Acquired Deformity of Elbow, Forearm, Hand, Wrist
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Aswan University HospitalUniversity, hospital or other
Study start: 1 Apr 2017 (actual)
Primary completion: 1 Apr 2020 (actual)
Study completion: 1 Oct 2020 (actual)
First posted: 29 Jan 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 3

Arm	Type	Receives
group Levo-bupivacaine	Other	Drug: Levobupivacaine(chirocaine) plus dexmedetomidine(precedex)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 levo-bupivacaine plus 50µg dexmedetomidine	Other	Drug: Levobupivacaine(chirocaine) plus dexmedetomidine(precedex)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 levo-bupivacaine plus 100µg dexmedetomidine	Other	Drug: Levobupivacaine(chirocaine) plus dexmedetomidine(precedex)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.

Who may qualify

Ages: 20 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Levobupivacaine(chirocaine) plus dexmedetomidine(precedex)Also: the efficacy of levo-bupivacaine alone and with dexmedetomidine in Ultrasound guided infraclavicular brachial plexus block for hand and forearm surgeriesevaluate the efficacy of levo-bupivacaine alone and with dexmedetomidine in Ultrasound guided infraclavicular brachial plexus block for hand and forearm surgeries	Drug	group Levo-bupivacaine, group levo-bupivacaine plus 100µg dexmedetomidine, group levo-bupivacaine plus 50µg dexmedetomidine

Primary outcome

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).
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.
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
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.

5 secondary outcomes

Visual analog scale (VAS)
Time frame: 24 hours
Postoperative first analgesic request time in hours
Time frame: 24 hours
Mean blood pressure in mmHg
Time frame: 24 hours
heart rate in beats / minute
Time frame: 24 hours
peripheral oxygen saturation
Time frame: 24 hours

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
Derived from this study: PubMed 36335297Ghazaly 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Levobupivacaine(chirocaine) plus dexmedetomidine(precedex) in people with Acquired Deformity of Elbow and Forearm, run by Aswan University Hospital at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Onset time of sensory block in minutes (time frame: 45 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04729868, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2021.