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

Not Applicable

Completed

• Conditions: Aortic Valve Stenosis
• Interventions: Procedure: Nerve block; Procedure: Local infiltration; Procedure: TAVI; Drug: Additional intraoperative analgesia; Drug: Additional postoperative analgesia

• Registration Number: NCT03863899
• Lead Sponsor: Medical University of Gdansk

Brief Summary

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

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 Timeline

• Study Start: 2018-07-02
• Study First Submitted: 2018-08-10
• Study First Submitted QC: 2019-03-03
• Study First Posted: 2019-03-05
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-14
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Local infiltration	Additional intraoperative analgesia	local anaesthesia infiltration performed by the operator for TAVI insertion with eventual intraoperative additional analgesia (AIA) and/or postoperative analgesia (APA)
Local infiltration	Additional postoperative analgesia	local anaesthesia infiltration performed by the operator for TAVI insertion with eventual intraoperative additional analgesia (AIA) and/or postoperative analgesia (APA)
Nerve block	Nerve block	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)
Nerve block	TAVI	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)
Nerve block	Additional intraoperative analgesia	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)
Nerve block	Additional postoperative analgesia	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	Local infiltration	local anaesthesia infiltration performed by the operator for TAVI insertion with eventual intraoperative additional analgesia (AIA) and/or postoperative analgesia (APA)
Local infiltration	TAVI	local anaesthesia infiltration performed by the operator for TAVI insertion with eventual intraoperative additional analgesia (AIA) and/or postoperative analgesia (APA)

Primary Outcome Measures

Name	Time	Method
Numeric Rating Scale (NRS)	24 hours	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).

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction with analgesia	3 days	Categorical quantification: Yes / No
Intraoperative and postoperative cost calculations	1 year	Sum of anesthetics and analgesics administered during operation and within first 24 hours after operation
Additional intraoperative analgesia consumption	24 hours	Fentanyl and paracetamol consumption during the operation.
Additional postoperative analgesia consumption	24 hours	Oxycodone and paracetamol consumption in first 24 hours after the operation

Trial Locations

Locations (1)

University Clinical Centre; 🇵🇱 Gdańsk, Poland