An interventional study of Nerve block and Local infiltration in Aortic Valve Stenosis, sponsored by Medical University of Gdansk. Completed at 1 site in Poland. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2020-01-18.
Sponsored by Medical University of Gdansk · Not applicable, Interventional, and Treatment
Ilioinguinal and iliohypogastric (ILIH) nerve blocks are frequently performed for analgesia in inguinal surgery.
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).
It is a prospective, randomized trial.
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)).
1,006 studies on the registry are indexed under Aortic Valve Stenosis; 284 are open to participants now.
This study's enrollment of 100 is below the median of 120 across 537 interventional studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →Medical University of Gdansk is the lead sponsor of 133 studies on the registry; 46 are open to participants now.
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Exclusion Criteria:
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)
Procedure: Nerve block · Procedure: TAVI · Drug: Additional intraoperative analgesia · Drug: Additional postoperative analgesia
local anaesthesia infiltration performed by the operator for TAVI insertion with eventual intraoperative additional analgesia (AIA) and/or postoperative analgesia (APA)
Procedure: Local infiltration · Procedure: TAVI · Drug: Additional intraoperative analgesia · Drug: Additional postoperative analgesia
drug mixture: 10-15 ml 0.5% ropivacaine plus 5 ml 1% lidocaine plus 1 mg dexamethasone plus 50 ug adrenaline
Also known as: Ultrasound-guided ilioinguinal iliohypogastric nerve block
15-20 ml of mixture of 0.5% bupivacaine and 1% lidocaine (1:1)
Also known as: Local anesthesia infiltration
Insertion of an aortic valve prothesis through the aorta accessed through femoral artery
Also known as: Transaortic valve implantation
Administration of any analgesics during the operation
Also known as: AIA
Administration of any analgesics within first 24 hours after the operation
Also known as: APA
Numeric Rating Scale (NRS)
The numeric rating scale will be used to determine the intraoperative and postoperative pain intensity levels of the patients. Pain intensity is scored 0-10 (0=no pain, 10=the worst pain imaginable). The pain intensity will be measured at 5 time points intraoperatively (femoral artery cannulation, aortic valve system introduction, aortic valve system removal, vessel closure devices insertion and the end of the operation) and at 2 time intervals postoperatively (0-12 hours and 12-24 hours).
Time frame: 24 hours
Additional intraoperative analgesia consumption
Fentanyl and paracetamol consumption during the operation.
Time frame: 24 hours
Additional postoperative analgesia consumption
Oxycodone and paracetamol consumption in first 24 hours after the operation
Time frame: 24 hours
Patient satisfaction with analgesia
Categorical quantification: Yes / No
Time frame: 3 days
Intraoperative and postoperative cost calculations
Sum of anesthetics and analgesics administered during operation and within first 24 hours after operation
Time frame: 1 year
Ran from Jul 2018 to primary completion in Dec 2019, 17 months.
Of 174 non-industry interventional studies with no phase under Aortic Valve Stenosis, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 79. This study's 17 months is below that.
Counting every sponsor, half of 277 studies reached it within 33 months; a quarter within 19 and three quarters within 72.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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