Contact information
Type
Scientific
Primary contact
Dr Stefano Camerani
ORCID ID
Contact details
Corso Giovecca 203
Ferrara
44121
Italy
s.camerani@ospfe.it
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Recovery after transition analgesia in patients undergoing carotid endarterectomy: comparison between anaesthetic superficial cervical plexus block and intravenous morphine
Acronym
Study hypothesis
The anaesthesia in vascular patients undergoing carotid endarterectomy (CEA) should not only guarantee haemodynamic stability and absence of pain, but also allow early awakening and early neurological assessment.
One of the most used anaesthesia techniques to facilitate early recovery from anaesthesia is total intravenous anaesthesia (TIVA), which is performed using two short half time drugs namely remifentanil and propofol. Nevertheless, this kind of anaesthesia requires transition analgesia, usually with morphine, to guarantee a pain free recovery. Therefore, the advantage taken by the administration of short half life anaesthesia drugs may be lost due to the effect of transition analgesia.
The aim of this study is compare the number of patients with Aldrete Score greater than or equal to 8 in two groups of patients who will receive different technique of analgesia transition: the superficial cervical plexus block with levobupivacaine 7.5% 10 ml, or the intravenous administration of a standard dose of morphine.
Secondary objectives are to compare pain, nausea, vomiting, and shiver in the two groups at fixed points in time in the post-operative period.
Ethics approval
Ethics Committee of the Azienda Ospedaliero-Universitaria di Ferrara, Ferrara, Italy, approved on the 27th July 2009
Study design
Single-centre randomised double blind study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Carotid endarterectomy
Intervention
A random number table will be generated by the computer. Accordingly, a physician not involved in data collection or patient-assessment, will prepare 64 sealed non-transparent envelopes, each reporting a code number and containing a sheet of paper reporting "Morphine" or "Block". The envelopes will be in a free deposit box in the office of the operative suite. The investigator administering morphine or performing the block will be the same and he will know the patient assignment after the induction of anaesthesia. At the end of surgery, the skin where the block was performed will be covered by plaster so the observer of the recovery period, not involved in the anaesthesia or aware of the patient group assignment, could not distinguish the technique used. The physician responsible for randomisation will maintain concealed the codes until the end of the study.
All patients enrolled will receive a standardised general anaesthesia. Anaesthesia monitoring will include electrocardiograms (ECG) (five derivations), invasive blood pressure measurement, saturation of peripheral oxygen (SpO2), train-of-four (TOF), Bispectral Index (BIS). Anaesthesia will be induced thought peripheral vein; after pre-oxygenation with fraction of inspired oxygen (FiO2) 1 through facial mask (3 minutes), remifentanil infusion (0.1 µg/kg/min) will be started and, after 5 minutes, a bolus of propofol (0.2 mg/kg intravenous [iv]) followed by cisatracurium (0.1 mg/kg iv) will be administered. The dosing of drugs will be calculated on the ideal weight (Broca formula): for man = height (cm) - 100; for woman = height (cm) - 104.
After tracheal intubation, patients will be mechanically ventilated with FiO2 0.5 in air, tidal volume 6 - 8 ml/kg, respiratory rate 12/min. General anaesthesia will be maintained with remifentanil and propofol infusion according to the required depth of anaesthesia.
Before starting surgery, the investigator will open the envelop containing the randomisation code, so patients will be assigned to one of the following two groups:
Group B: receive a superficial cervical block with levobupivacaine 7.5% 10 ml after induction of anaesthesia and before the surgical incision
Group M: morphine will be administered 30 minutes before the end of surgery, in a dose of 0.15 mg/kg iv in patients aged less than or equal to 75 age or 0.10 mg/kg in patients over 75 age.
The observer who will perform the post-operative assessment of the patient will not be involved in the anaesthesia or aware of the patient group assignment. About 60 minutes before the end of surgery, acetaminophen 1 g will be administered intravenously in 15 minutes to both groups. At the end of surgical operation, the decurarisation with prostigmine and atropine will be performed according to the TOF value and then the infusion of propofol and remifentanil will be interrupted (time T0).
In the recovery period, Aldrete score will be measured at 0, 5, 10, and 30 minutes after extubation. At the same time, respiratory rate (RR), heart rate (HR), pain (Numerical Rating Scale 0 - 10), nausea (yes or no), vomiting (yes or no), and shivers (yes or no) were recorded. Subsequently (60, 120, and 180 minutes after extubation), SpO2, RR, HR, arterial pressure, pain, nausea, vomiting and shivers will again be assessed. All of the assessments will be performed by an observer not involved in the anaesthesia or aware of the patient group assignment.
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measure
Aldrete score, measured at 0, 5, 10, and 30 minutes
Secondary outcome measures
Measured at 0, 5, 10, 30, 60, 120, and 180 minutes after extubation:
1. Respiratory rate (RR)
2. Heart rate (HR)
3. SpO2
4. Arterial pressure
5. Pain (Numerical Rating Scale 0 - 10)
6. Nausea (yes or no)
7. Vomiting (yes or no)
8. Shivers (yes or no)
Overall trial start date
30/11/2009
Overall trial end date
31/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients aged 18 years or greater, either sex
2. Undergoing elective carotid endarterectomy
3. No contraindication to local anaesthetic block
4. Give informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
32 patients per group (total: 64 patients)
Participant exclusion criteria
1. Aged less than 18 years
2. Refusal
3. Urgent surgery (planned less than 24 hours in advance)
4. Patients with psychiatric pathology or inability to cooperate
5. Presence of contraindication to local anaesthetic block (i.e. allergy)
Recruitment start date
30/11/2009
Recruitment end date
31/12/2010
Locations
Countries of recruitment
Italy
Trial participating centre
Corso Giovecca 203
Ferrara
44121
Italy
Sponsor information
Organisation
University of Ferrara (Italy) - Department of Surgical, Anaesthetic and Radiological Sciences
Sponsor details
Section of Anaesthesiology and Intensive Care Medicine
Via Savonarola 9
Ferrara
44121
Italy
sar@unife.it
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
University/education
Funder name
University of Ferrara (Italy) - Department of Surgical, Anaesthetic and Radiological Sciences
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list