Analgesia in Patients Undergoing Transfemoral Transcatheter Aortic Valve Implantation (TF-TAVI)
NCT ID: NCT03863899
Last Updated: 2020-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2018-07-02
2019-12-31
Brief Summary
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The investigators hypothesized that preoperative ultrasound-guided ilioinguinal and iliohypogastric (ILIH) nerve blocks will produce better intraoperative analgesia and less analgesic requirement postoperatively in comparison to commonly used preoperative local infiltration anaesthesia for patients undergoing transfemoral transcatheter aortic valve implantation (TF-TAVI).
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Detailed Description
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The patients will be randomized to one of the 2 groups:
Group 1 - NERVE BLOCK. Ultrasound-guided ILIH nerve block will be performed by attending anaesthesiologist.
Group 2 - LOCAL INFILTRATION. Local anaesthetic infiltration of the operative area will be performed by operator.
During surgery patients will receive low-dose propofol infusion in order to achieve conscious sedation level, when indicated.
An extra dose of local anaesthetic drug for infiltration of the surgical field or intravenous fentanyl or/and intravenous paracetamol will be given as rescue analgesics in patients reporting pain sensation.
The patients will be observed for 24 hours. The pain at rest will be assessed using numeric rating scale (NRS 0 -10; 0 = no pain: 10 = max pain imaginable).
On the first postoperative day intravenous analgesics will be given on demand (paracetamol 1 g iv (if NRS \<5) and oxycodone 2,5 mg iv (if NRS \> or = 5)).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Nerve block
ultrasound-guided ilioinguinal iliohypogastric nerve block performed by the anaesthesiologist for Transaortic valve implantation (TAVI) insertion with eventual additional intraoperative analgesia (AIA) and/or additional postoperative analgesia (APA)
Nerve block
drug mixture: 10-15 ml 0.5% ropivacaine plus 5 ml 1% lidocaine plus 1 mg dexamethasone plus 50 ug adrenaline
TAVI
Insertion of an aortic valve prothesis through the aorta accessed through femoral artery
Additional intraoperative analgesia
Administration of any analgesics during the operation
Additional postoperative analgesia
Administration of any analgesics within first 24 hours after the operation
Local infiltration
local anaesthesia infiltration performed by the operator for TAVI insertion with eventual intraoperative additional analgesia (AIA) and/or postoperative analgesia (APA)
Local infiltration
15-20 ml of mixture of 0.5% bupivacaine and 1% lidocaine (1:1)
TAVI
Insertion of an aortic valve prothesis through the aorta accessed through femoral artery
Additional intraoperative analgesia
Administration of any analgesics during the operation
Additional postoperative analgesia
Administration of any analgesics within first 24 hours after the operation
Interventions
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Nerve block
drug mixture: 10-15 ml 0.5% ropivacaine plus 5 ml 1% lidocaine plus 1 mg dexamethasone plus 50 ug adrenaline
Local infiltration
15-20 ml of mixture of 0.5% bupivacaine and 1% lidocaine (1:1)
TAVI
Insertion of an aortic valve prothesis through the aorta accessed through femoral artery
Additional intraoperative analgesia
Administration of any analgesics during the operation
Additional postoperative analgesia
Administration of any analgesics within first 24 hours after the operation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* using a minimalist approach of local anesthesia or nerve block with conscious sedation
Exclusion Criteria
* allergy to local anaesthetic
* TF-TAVI requiring general anesthesia or surgical cut-down
* patients with major cognitive impairment and inability to assess their pain level in Numerical Rating Scale (NRS).
65 Years
ALL
No
Sponsors
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Medical University of Gdansk
OTHER
Responsible Party
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Liudmila Hasak, MD, PhD
Principal Investigator
Principal Investigators
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Romuald Lango, MD, PhD
Role: STUDY_CHAIR
Department of Cardiac Anaesthesiolgy UCC of Gdansk
Locations
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University Clinical Centre
Gdansk, , Poland
Countries
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Other Identifiers
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305/2018
Identifier Type: -
Identifier Source: org_study_id
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