Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000942752
Ethics application status
Approved
Date submitted
10/03/2022
Date registered
4/07/2022
Date last updated
4/07/2022
Date data sharing statement initially provided
4/07/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Dexmedetomidine as an adjuvant to levobupivacaine and
lidocaine in ultrasound-guided superficial cervical block for
carotid endarterectomy: a prospective, randomised, double-
blinded study
Scientific title
Duration of sensory block and analgesia when using dexmedetomidine as an adjuvant to levobupivacaine and lidocaine in ultrasound-guided superficial cervical block for carotid endarterectomy: a prospective, randomised, double-blinded study
Secondary ID [1] 306651 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Superficial cervical block for carotid endarterectomy. 325581 0
Condition category
Condition code
Anaesthesiology 322949 322949 0 0
Anaesthetics
Surgery 323373 323373 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Superficial cervical block (SCB) was performed with 2 mg/kg 0.5% levobupivacaine, 200 mg of 2% lidocaine supplemented with saline to a volume of 50 mL. Subject group S
additionally received 50 micrograms of dexmedetomidine in mixture. The anaesthetist who performes the procedure positioned the patient in supine position, with the head resting on pillow, looking to the opposite side. With the patient in the proper position, the skin was disinfected and the transducer is placed at the midpoint of the sternocleidomastoid muscle. The cervical plexus is identified, the needle is passed with in-plane approach behind the sternocleidomastoid muscle, the tip is placed adjacent to the plexus, and 15mL of local anesthetic mixture is administered. The rest of the local anesthetic mixture (35 mL) was injected subcutaneous cephalad and caudad along the length of the sternocleidomastoid muscle posterior border, and along the lower edge of the body of the mandible. The procedure was performed approximately 30 min prior to the initial surgical incision.

Intervention code [1] 323091 0
Treatment: Drugs
Comparator / control treatment
Patients were randomly assigned into two groups: both groups received 2 mg/kg
0.5% levobupivacaine with 200 mg of 2% lidocaine supplemented with saline to a volume of 50 mL.
Control group
Active

Outcomes
Primary outcome [1] 330717 0
The onset of sensory block. assessed by anaesthetist review.
Timepoint [1] 330717 0
Timepoints are 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 (primary endpoint) minutes after performing SCP block.
Primary outcome [2] 331110 0
The duration of sensory block assessed by anaesthetist review.
Timepoint [2] 331110 0
Timepoints are 2, 4, 6, 8, 10 and 12 (primary endpoint) hours after performing SCP block.
Primary outcome [3] 331111 0
Duration of analgesia. assessed by anaesthetist review.
Timepoint [3] 331111 0
Timepoints are 2, 4, 6, 8, 10 and 12 (primary endpoint) hours after performing SCP block.
Secondary outcome [1] 407300 0
Bradycardia measured by pulse oximeter.
Timepoint [1] 407300 0
Continuously monitored from start of SCP block to 2 hours after surgery completion.
Secondary outcome [2] 410640 0
Respiratory depression measured by pulse oximeter
Timepoint [2] 410640 0
Continuously monitored from start of SCP block to 2 hours after surgery completion.
Secondary outcome [3] 410641 0
Hypotension measured by sphygmomanometer
Timepoint [3] 410641 0
Continuously monitored from start of SCP block to 2 hours after surgery completion.
Secondary outcome [4] 410642 0
Nausea assessed by patient complaint- data collected from medical records.
Timepoint [4] 410642 0
Continuously monitored from start of SCP block to 2 hours after surgery completion.
Secondary outcome [5] 410643 0
Shivering assessed by patient complaint- data collected from medical records.
Timepoint [5] 410643 0
Continuously monitored from start of SCP block to 2 hours after surgery completion.
Secondary outcome [6] 410644 0
Pruritis assessed by patient complaint- data collected from medical records.
Timepoint [6] 410644 0
Continuously monitored from start of SCP block to 2 hours after surgery completion;
Secondary outcome [7] 410645 0
Vomiting assessed by patient complaint- data collected from medical records.
Timepoint [7] 410645 0
Continuously monitored from start of SCP block to 2 hours after surgery completion.

Eligibility
Key inclusion criteria
Patients with a critical stenosis (>70%) of the carotid artery. ASA I, II and III.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients older than 80 years, ASA > IV, severe liver dysfunction, body mass index >40, allergies to local anesthetics.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was done by sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
28/09/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
55
Final
Recruitment outside Australia
Country [1] 24652 0
Croatia
State/province [1] 24652 0
Country [2] 24653 0
Croatia
State/province [2] 24653 0
Zagreb

Funding & Sponsors
Funding source category [1] 310963 0
Hospital
Name [1] 310963 0
University hospital centre Sestre Milosrdnice
Country [1] 310963 0
Croatia
Primary sponsor type
Hospital
Name
University hospital centre Sestre Milosrdnice
Address
Vinogradska cesta 29, 10000, Zagreb
Country
Croatia
Secondary sponsor category [1] 312285 0
None
Name [1] 312285 0
None
Address [1] 312285 0
None
Country [1] 312285 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310522 0
University hospital centre Sestre Milosrdnice Ethical Committee
Ethics committee address [1] 310522 0
Vinogradska cesta 29, 10000, Zagreb
Ethics committee country [1] 310522 0
Croatia
Date submitted for ethics approval [1] 310522 0
Approval date [1] 310522 0
09/09/2021
Ethics approval number [1] 310522 0

Summary
Brief summary
Study hypothesis:
Dexmedetomidine increases the duration of sensory block and analgesia when using it as an adjuvant to levobupivacaine and lidocaine in ultrasound-guided superficial cervical block for carotid endarterectomy surgery.

Numerous additives were tried in combination with local anaesthetics to increase the quality of anaesthesia and prolong postoperative analgesia. Research on use of a-2 receptor agonist dexmedetomidine as an adjuvant in regional anaesthesia has positive effect on duration of block, but there are no studies on usage in superficial cervical block (SCB) in carotid endarterectomy (CEA), where management of mean arterial pressure is essential. We therefore designed a prospective, randomised, double-blinded study to investigate the effect of adding dexmedetomidine to levobupivacaine and lidocaine on the quality of SCB in CEA surgery.,All patients had invasive blood pressure monitoring and parameters were noted every 5 minutes. Patients were randomly assigned into two groups: both groups received 2 mg/kg 0.5% levobupivacaine with 200 mg of 2% lidocaine supplemented with saline to a volume of 50 mL. Subject group S additionally received 50 micrograms of dexmedetomidine in mixture. The onset and duration of sensory block and analgesia, haemodynamic parameters and side effects: bradycardia, hypotension, respiratory depression, nausea, vomiting, pruritus and shivering were recorded.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117946 0
Dr Matteo Škrtic
Address 117946 0
University Hospital Centre Sestre Milorsdnice
Vinogradska cesta 29, 10000 Zagreb
Country 117946 0
Croatia
Phone 117946 0
+385997347250
Fax 117946 0
Email 117946 0
matteo.skrtic@kbcsm.hr
Contact person for public queries
Name 117947 0
Dr Matteo Škrtic
Address 117947 0
University Hospital Centre Sestre Milorsdnice
Vinogradska cesta 29, 10000 Zagreb
Country 117947 0
Croatia
Phone 117947 0
+385997347250
Fax 117947 0
Email 117947 0
matteo.skrtic@kbcsm.hr
Contact person for scientific queries
Name 117948 0
Dr Matteo Škrtic
Address 117948 0
University Hospital Centre Sestre Milorsdnice
Vinogradska cesta 29, 10000 Zagreb
Country 117948 0
Croatia
Phone 117948 0
+385997347250
Fax 117948 0
Email 117948 0
matteo.skrtic@kbcsm.hr

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseHemodynamic Safety and Effect of Dexmedetomidine on Superficial Cervical Block Quality for Carotid Endarterectomy: A Prospective Study.2023https://dx.doi.org/10.1053/j.jvca.2023.06.009
N.B. These documents automatically identified may not have been verified by the study sponsor.