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

Medical University of Gdansk100 enrolled

Overview

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)).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Aortic Valve Stenosis

Interventions

Nerve blockPROCEDURE

drug mixture: 10-15 ml 0.5% ropivacaine plus 5 ml 1% lidocaine plus 1 mg dexamethasone plus 50 ug adrenaline

Local infiltrationPROCEDURE

15-20 ml of mixture of 0.5% bupivacaine and 1% lidocaine (1:1)

TAVIPROCEDURE

Insertion of an aortic valve prothesis through the aorta accessed through femoral artery

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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).

Locations (1)

University Clinical Centre

Gdansk, Poland

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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