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

Medical University of Gdansk

Status: Completed

Conditions: Aortic Valve Stenosis

Treatments: Procedure: Nerve block; Drug: Additional postoperative analgesia; Procedure: TAVI; Procedure: Local infiltration; Drug: Additional intraoperative analgesia

Study type: Interventional

Funder types: Other

Identifiers

NCT03863899

305/2018

Details and patient eligibility

About

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).

Full description

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)).

Enrollment: 100 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Nerve block

Experimental group

Description:

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)

Treatment:

Drug: Additional intraoperative analgesia

Procedure: TAVI

Drug: Additional postoperative analgesia

Procedure: Nerve block

Local infiltration

Active Comparator group

Description:

local anaesthesia infiltration performed by the operator for TAVI insertion with eventual intraoperative additional analgesia (AIA) and/or postoperative analgesia (APA)

Treatment:

Drug: Additional intraoperative analgesia

Procedure: Local infiltration

Procedure: TAVI

Drug: Additional postoperative analgesia