Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001230741
Ethics application status
Approved
Date submitted
2/08/2022
Date registered
12/09/2022
Date last updated
12/09/2022
Date data sharing statement initially provided
12/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of superficial cervical plexus block and combination of superficial cervical plexus and carotid sheath block in carotid endarterectomy: a prospective randomized study
Scientific title
Block onset time and duration of sensory block in patients having received both superficial cervical plexus block and carotid sheath block in carotid endarterectomy: a prospective randomized study
Secondary ID [1] 307630 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 327119 0
carotid sheath block for carotid endarterectomy 327120 0
Condition category
Condition code
Anaesthesiology 324261 324261 0 0
Anaesthetics
Cardiovascular 324262 324262 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One group will receive a superficial cervical block and the other group will receive a combination of a superficial cervical and "carotid sheath" block with an ultrasound technique performed by an experienced anesthesiologist (defined as more than 10 years of experience in clinical practice).

The anaesthetist who performs the procedure positions 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 is 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) is 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.

Ultrasound-guided superficial cervical block combined with "carotid sheath" block will be performed with the help of a high-frequency linear probe that will be placed on the lateral side of the neck at the midpoint of the posterior edge of the sternocleidomastoid muscle, so that the posterior edge of the sternocleidomastoid muscle is in the center of the screen. A carotid artery is identified. Then, a 25 G needle will be introduced from the posterior side through the skin and platysma, the tip of the needle is placed adjacent to the carotid artery and its sheath and a total of 15 mL of local anesthetic mixture will be injected circularly around the carotid artery. The rest of the mixture of a total of 40-50 mL will be distributed equally as in a superficial cervical block.

Both groups will receive a total of 40-50 mL of the mixture; 2 mg/kg 0.5% levobupivacaine and 2mg/kg 2% lidocaine, supplemented with saline to the required volume.

The procedure will be performed once only approximately 30 min prior to the surgical incision.
Intervention code [1] 324080 0
Treatment: Devices
Intervention code [2] 324341 0
Treatment: Drugs
Comparator / control treatment
Patients undergoing elective carotid endarterectomy surgery will be randomly assigned into two groups: One group receiving ultrasound-guided carotid sheath block and superficial cervical block while the other (control group) group receiving superficial cervical block alone.
Control group
Active

Outcomes
Primary outcome [1] 332074 0
The onset of sensory block assessed by anesthetist review by pinching the skin with a surgical pincer overlying the sternocleidomastoid muscle.
Timepoint [1] 332074 0
Timepoints are 1,2,3,4,5,6,7,8,9 and 10 (primary endpoint) minutes after performing the block.
Primary outcome [2] 332075 0
The duration of sensory block assessed by anesthetist review; the anesthetist will evaluate patient's pain score according to NPRS (numeric pain rating scale) every 2 hours after performing the block up to 12 hours after the administration of the block.
Timepoint [2] 332075 0
Timepoints are 2,4,6,8,10 and 12 (primary endpoint) hours after performing the block.
Primary outcome [3] 332076 0
Time to request for additional analgesia by patient assessed by anesthetist review, using patient's NPRS (numeric pain rating scale, 0-10) scale. The patient will inform the nurse who will inform the anesthetist about the additional analgesia.
Timepoint [3] 332076 0
Timepoints are 2,4,6,8,10 and 12 (primary endpoint) hours after performing the block.
Secondary outcome [1] 412098 0
Bradycardia measured/detected by pulse oximetry.
Timepoint [1] 412098 0
Continuously monitored from the start of the block up to 2 hours after surgery completion.
Secondary outcome [2] 412099 0
Respiratory depression measured/detected by pulse oximetry.
Timepoint [2] 412099 0
Continuously monitored from the start of the block up to 2 hours after surgery completion.
Secondary outcome [3] 412100 0
Hypotension measured/detected by arterial catheter.
Timepoint [3] 412100 0
Blood pressure monitored from the start of the block up to 2 hours after surgery completion, with median values recorded every 5 minutes.
Secondary outcome [4] 412101 0
Nausea assessed by patient complaint - data collected from medical records.
Timepoint [4] 412101 0
Continuously monitored from the start of the block up to 2 hours after surgery completion.
Secondary outcome [5] 412102 0
Shivering assessed by patient complaint - data collected from medical records.
Timepoint [5] 412102 0
Continuously monitored from the start of the block up to 2 hours after surgery completion.
Secondary outcome [6] 412103 0
Pruritus assessed by patient complaint - data collected from medical records.
Timepoint [6] 412103 0
Continuously monitored from the start of the block up to 2 hours after surgery completion.
Secondary outcome [7] 412104 0
Vomiting assessed by patient complaint - data collected from medical records.
Timepoint [7] 412104 0
Continuously monitored from the start of the block up to 2 hours after surgery completion.
Secondary outcome [8] 413478 0
Hematoma formation at the puncture site assessed by the anesthesia provider by visual inspection of the patient or by patient complaint - data collected from medical records.
Timepoint [8] 413478 0
Continuously monitored from the start of the block up to 2 hours after surgery completion, by visual inspection of the neck.
Secondary outcome [9] 413479 0
Signs of systemic toxicity of local anaesthetics: dizziness assessed by patient complaint - data collected from medical records.
Timepoint [9] 413479 0
Continuously monitored from the start of the block up to 2 hours after surgery completion.
Secondary outcome [10] 413480 0
Signs of systemic toxicity of local anaesthetics: tinnitus assessed by patient complaint - data collected from medical records.
Timepoint [10] 413480 0
Continuously monitored from the start of the block up to 2 hours after surgery completion.
Secondary outcome [11] 413481 0
Signs of systemic toxicity of local anaesthetics: disorientation assessed by the anesthesia provider when asking simple questions (date, year).
Timepoint [11] 413481 0
Continuously monitored from the start of the block up to 2 hours after surgery completion.
Secondary outcome [12] 413482 0
Signs of systemic toxicity of local anaesthetics: drowsiness assessed by the anesthesia provider by visual inspection of the patient.
Timepoint [12] 413482 0
Continuously monitored from the start of the block up to 2 hours after surgery completion.
Secondary outcome [13] 413483 0
Signs of systemic toxicity of local anaesthetics: tremors assessed by the anesthesia provider by visual inspection of the patient or by patient complaint - data collected from medical records.
Timepoint [13] 413483 0
Continuously monitored from the start of the block up to 2 hours after surgery completion.
Secondary outcome [14] 413484 0
Signs of systemic toxicity of local anaesthetics: convulsions assessed by the anesthesia provider by visual inspection of the patient.
Timepoint [14] 413484 0
Continuously monitored from the start of the block up to 2 hours after surgery completion.
Secondary outcome [15] 413485 0
Signs of systemic toxicity of local anaesthetics: respiratory depression assessed by the anesthesia provider by visual inspection of the patient and the respiratory rate on the monitor less than 12/min, or dropping values on pulse oximetry (below 94%).
Timepoint [15] 413485 0
Continuously monitored from the start of the block up to 2 hours after surgery completion.
Secondary outcome [16] 413486 0
Signs of systemic toxicity of local anaesthetics: cardiovascular depression assessed by the anesthesia provider by visual inspection of the patient and presence of hypotension (systolic blood pressure less than 90 mm Hg) on the monitor alongside tachycardia (heart rate higher than 100 beats per minute), without palpable peripheral pulses.
Timepoint [16] 413486 0
Continuously monitored from the start of the block up to 2 hours after surgery completion.
Secondary outcome [17] 413487 0
Nerve injury after peripheral nerve blockade assessed by patient complaint - data collected from medical records.
Timepoint [17] 413487 0
Continuously monitored from the start of the block up to 2 hours after surgery completion.
Secondary outcome [18] 413811 0
Cumulative dose of analgesic consumption during the first 24 h postoperatively - data collected from medical records.
Timepoint [18] 413811 0
Total dose of analgesics administered postoperatively during 24 h expressed as oral morphine equivalents in milligrams.

Eligibility
Key inclusion criteria
Patients with critical stenosis (>70%) of the carotid artery. ASA grade 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, hepatic dysfunction, severe malnutrition, morbid obesity (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 is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomization table created by computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The preparation of the documentation included a power analysis for the t-test at effect size 0.5, power 0.8 and alpha 0.05, and it was shown that 60 respondents, 30 per group, are sufficient for this research.
After obtaining the approval of the ethics committee, the patients who will be in the test group (group S) and the control group (group C) will be determined using a random number generator in a ratio of 1:1.
The study will include sixty consecutive patients undergoing elective carotid endarterectomy with critical stenosis (>70%), ASA II or III status.

The time immediately after the application of the block is marked as time 0 (t = 0), and the examiner evaluates analgesia with the verbal NPRS (numeric pain rating scale, 0-10, where 0 is the absence of pain and 10 is the worst possible pain) method in standardized times, t= 2h, t=4h, t=6h, t=8h, t=10h and t=12h. If the patient requests additional analgesia, the time in minutes from the block (the moment of local anesthetic injection) to the additional analgesia will be recorded, and the duration of the (I)sensory block will be considered the time from the block to the additional analgesia. The time to (II) the onset of sensory block will be considered the time from the end of local anesthetic administration to the achievement of full sensory block. (III) Cumulative dose of analgesic consumption during the first 24 h postoperatively will be considered the total dose of analgesics administered postoperatively during 24 h expressed as oral morphine equivalents in milligrams.

A log-rank test will be performed to compare a probability of NPRS equal or less than 3 during follow-up time, with results described as Kaplan-Meier curves.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/09/2022
Actual
Date of last participant enrolment
Anticipated
15/01/2023
Actual
Date of last data collection
Anticipated
16/01/2023
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 24922 0
Croatia
State/province [1] 24922 0
Zagreb

Funding & Sponsors
Funding source category [1] 311894 0
Hospital
Name [1] 311894 0
University Hospital Centre Sestre Milosrdnice
Country [1] 311894 0
Croatia
Primary sponsor type
Hospital
Name
University Hospital Centre Sestre Milosrdnice
Address
Vinogradska cesta 29, 10000 Zagreb
Country
Croatia
Secondary sponsor category [1] 313374 0
None
Name [1] 313374 0
none
Address [1] 313374 0
Country [1] 313374 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311329 0
University Hospital Centre Sestre Milosrdnice Ethical Committee
Ethics committee address [1] 311329 0
Ethics committee country [1] 311329 0
Croatia
Date submitted for ethics approval [1] 311329 0
10/07/2022
Approval date [1] 311329 0
18/07/2022
Ethics approval number [1] 311329 0
251-29-11-21-06

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120734 0
Dr Anamarija Kruc
Address 120734 0
University Hospital Centre Sestre Milosrdnice
Vinogradska cesta 29, 10 000 Zagreb
Country 120734 0
Croatia
Phone 120734 0
+389989589972
Fax 120734 0
Email 120734 0
[email protected]
Contact person for public queries
Name 120735 0
Tomislav Radocaj
Address 120735 0
University Hospital Centre Sestre Milosrdnice
Vinogradska cesta 29, 10 000 Zagreb
Country 120735 0
Croatia
Phone 120735 0
+385911262586
Fax 120735 0
Email 120735 0
[email protected]
Contact person for scientific queries
Name 120736 0
Lada Lijovic
Address 120736 0
University Hospital Centre Sestre Milosrdnice
Vinogradska cesta 29, 10 000 Zagreb
Country 120736 0
Croatia
Phone 120736 0
+385958950953
Fax 120736 0
Email 120736 0
[email protected]

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
No additional documents have been identified.