Analgesia in Patients Undergoing Transfemoral Transcatheter Aortic Valve Implantation (TF-TAVI)

Study Overview
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Brief Summary
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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).

Detailed Description
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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)).

Official Title
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Pain Control With Ultrasound-guided Ilioinguinal Iliohypogastric Nerve Block Compared With Local Anesthesia Infiltration in Patients Undergoing Transfemoral Transcatheter Aortic Valve Implantation (TF-TAVI): a Prospective, Randomized Trial

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Procedure: Nerve block
* Procedure: Local infiltration
* Procedure: TAVI
* Drug: Additional intraoperative analgesia
* Drug: Additional postoperative analgesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with aortic valve stenosis referred for TF-TAVI using a minimalist approach of local anesthesia or nerve block with conscious sedation Exclusion Criteria: patient's refusal to participate 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).

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nerve block<br>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<br>* drug mixture: 10-15 ml 0.5% ropivacaine plus 5 ml 1% lidocaine plus 1 mg dexamethasone plus 50 ug adrenaline<br>* Other names: Ultrasound-guided ilioinguinal iliohypogastric nerve block;Procedure: TAVI<br>* Insertion of an aortic valve prothesis through the aorta accessed through femoral artery<br>* Other names: Transaortic valve implantation;Drug: Additional intraoperative analgesia<br>* Administration of any analgesics during the operation<br>* Other names: AIA;Drug: Additional postoperative analgesia<br>* Administration of any analgesics within first 24 hours after the operation<br>* Other names: APA;|
| Active Comparator: Local infiltration<br>local anaesthesia infiltration performed by the operator for TAVI insertion with eventual intraoperative additional analgesia (AIA) and/or postoperative analgesia (APA) | Procedure: Local infiltration<br>* 15-20 ml of mixture of 0.5% bupivacaine and 1% lidocaine (1:1)<br>* Other names: Local anesthesia infiltration;Procedure: TAVI<br>* Insertion of an aortic valve prothesis through the aorta accessed through femoral artery<br>* Other names: Transaortic valve implantation;Drug: Additional intraoperative analgesia<br>* Administration of any analgesics during the operation<br>* Other names: AIA;Drug: Additional postoperative analgesia<br>* Administration of any analgesics within first 24 hours after the operation<br>* Other names: APA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ilioinguinal Iliohypogastric nerve block, local anaesthesia infiltration, ultrasound-guided, pain control