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

NCT03863899 | Completed DMC

• 1 other identifier: 305/2018
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Aortic Valve Stenosis

Keywords

Ilioinguinal Iliohypogastric nerve block; local anaesthesia infiltration; ultrasound-guided; pain control

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Additional intraoperative analgesia consumption

  24 hours

• Additional postoperative analgesia consumption

  24 hours

• Patient satisfaction with analgesia

  3 days

• Intraoperative and postoperative cost calculations

  1 year

Study Arms (2)

Nerve block

EXPERIMENTAL

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; Procedure: TAVI; Drug: Additional intraoperative analgesia; Drug: Additional postoperative analgesia

Local infiltration

ACTIVE COMPARATOR

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

Procedure: Local infiltration; Procedure: TAVI; Drug: Additional intraoperative analgesia; Drug: Additional postoperative analgesia

Interventions

Nerve block PROCEDURE

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

Also known as: Ultrasound-guided ilioinguinal iliohypogastric nerve block

Nerve block

Local infiltration PROCEDURE

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

Also known as: Local anesthesia infiltration

Local infiltration

TAVI PROCEDURE

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

Also known as: Transaortic valve implantation

Local infiltration; Nerve block

Additional intraoperative analgesia DRUG

Administration of any analgesics during the operation

Also known as: AIA

Local infiltration; Nerve block

Additional postoperative analgesia DRUG

Administration of any analgesics within first 24 hours after the operation

Also known as: APA

Local infiltration; Nerve block

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• patients with aortic valve stenosis referred for TF-TAVI
• using a minimalist approach of local anesthesia or nerve block with conscious sedation

You may not qualify if:

• 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).

Sponsors & Collaborators

• Medical University of Gdansk: lead

Study Sites (1)

University Clinical Centre

Gdansk, 80-211, Poland

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Agnosia

Interventions

Nerve Block; Anesthesia, Local

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative

Study Officials

• Romuald Lango, MD, PhD

  Department of Cardiac Anaesthesiolgy UCC of Gdansk

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 10, 2018
• First Posted: March 5, 2019
• Study Start: July 2, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

PL (1)