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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)).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nerve block | Experimental | 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) |
|
| Local infiltration | Active Comparator | local anaesthesia infiltration performed by the operator for TAVI insertion with eventual intraoperative additional analgesia (AIA) and/or postoperative analgesia (APA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nerve block | Procedure | drug mixture: 10-15 ml 0.5% ropivacaine plus 5 ml 1% lidocaine plus 1 mg dexamethasone plus 50 ug adrenaline |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Additional intraoperative analgesia consumption | Fentanyl and paracetamol consumption during the operation. | 24 hours |
| Additional postoperative analgesia consumption | Oxycodone and paracetamol consumption in first 24 hours after the operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Romuald Lango, MD, PhD | Department of Cardiac Anaesthesiolgy UCC of Gdansk | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Clinical Centre | Gdansk | 80-211 | Poland |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D009407 | Nerve Block |
| D000772 | Anesthesia, Local |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D003714 | Denervation |
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| Local infiltration | Procedure | 15-20 ml of mixture of 0.5% bupivacaine and 1% lidocaine (1:1) |
|
|
| TAVI | Procedure | Insertion of an aortic valve prothesis through the aorta accessed through femoral artery |
|
|
| Additional intraoperative analgesia | Drug | Administration of any analgesics during the operation |
|
|
| Additional postoperative analgesia | Drug | Administration of any analgesics within first 24 hours after the operation |
|
|
| 24 hours |
| Patient satisfaction with analgesia | Categorical quantification: Yes / No | 3 days |
| Intraoperative and postoperative cost calculations | Sum of anesthetics and analgesics administered during operation and within first 24 hours after operation | 1 year |
| D014694 |
| Ventricular Outflow Obstruction |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019635 |
| Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |