Clinical trial NCT04729868: 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
Overall status: COMPLETED
Phase: NA
Conditions: Acquired Deformity of Elbow
Forearm
Hand
Wrist
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2021-01-29
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Onset time of sensory block in minutes
timeFrame: 45 minutes
measure: onset time of motor blockade in minutes using the modified Bromage scale (Three-point scale)
timeFrame: 24 hours
measure: Duration of sensory block in hours
timeFrame: 24 hours
measure: Duration of motor block in hours
timeFrame: 24 hours
Secondary outcomes:
measure: Visual analog scale (VAS)
timeFrame: 24 hours
measure: Postoperative first analgesic request time in hours
timeFrame: 24 hours
measure: Mean blood pressure in mmHg
timeFrame: 24 hours
measure: heart rate in beats / minute
timeFrame: 24 hours
measure: peripheral oxygen saturation
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Zaher
Study officials:
References:
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.