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NCT Number: NCT03863899

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

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).

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Key information

Conditions

Aortic Valve Stenosis Agnosia Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Ventricular Outflow Obstruction

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Clinical Centre

Gdansk, 80-211, Poland

About this study

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)).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Nerve Block

Procedure

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

Other names: Ultrasound-guided ilioinguinal iliohypogastric nerve block

local infiltration

Procedure

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

Other names: Local anesthesia infiltration

TAVI

Procedure

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

Other names: Transaortic valve implantation

Additional intraoperative analgesia

Drug

Administration of any analgesics during the operation

Other names: AIA

Additional postoperative analgesia

Drug

Administration of any analgesics within first 24 hours after the operation

Other names: APA

Primary outcomes

  1. Numeric Rating Scale (NRS)

    Time frame: 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 outcomes

  1. Additional intraoperative analgesia consumption

    Time frame: 24 hours

    Fentanyl and paracetamol consumption during the operation.

  2. Additional postoperative analgesia consumption

    Time frame: 24 hours

    Oxycodone and paracetamol consumption in first 24 hours after the operation

  3. Patient satisfaction with analgesia

    Time frame: 3 days

    Categorical quantification: Yes / No

  4. Intraoperative and postoperative cost calculations

    Time frame: 1 year

    Sum of anesthetics and analgesics administered during operation and within first 24 hours after operation

Sponsors and collaborators

Lead sponsor

Medical University of Gdansk

Other

Registry information

Official study title

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

Acronym: TF-TAVI

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 5, 2019
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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