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

January 14, 2020 updated by: Liudmila Hasak, MD, PhD, Medical University of Gdansk

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Gdańsk, Poland, 80-211
        • University Clinical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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)
Procedure: Nerve block
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
Procedure: TAVI
Insertion of an aortic valve prothesis through the aorta accessed through femoral artery
Other Names:
  • Transaortic valve implantation
Drug: Additional intraoperative analgesia
Administration of any analgesics during the operation
Other Names:
  • AIA
Drug: Additional postoperative analgesia
Administration of any analgesics within first 24 hours after the operation
Other Names:
  • APA
ACTIVE_COMPARATOR: Local infiltration
local anaesthesia infiltration performed by the operator for TAVI insertion with eventual intraoperative additional analgesia (AIA) and/or postoperative analgesia (APA)
Procedure: TAVI
Insertion of an aortic valve prothesis through the aorta accessed through femoral artery
Other Names:
  • Transaortic valve implantation
Drug: Additional intraoperative analgesia
Administration of any analgesics during the operation
Other Names:
  • AIA
Drug: Additional postoperative analgesia
Administration of any analgesics within first 24 hours after the operation
Other Names:
  • APA
Procedure: Local infiltration
15-20 ml of mixture of 0.5% bupivacaine and 1% lidocaine (1:1)
Other Names:
  • Local anesthesia infiltration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Gdansk

Investigators

  • Study Chair: Romuald Lango, MD, PhD, Department of Cardiac Anaesthesiolgy UCC of Gdansk

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 2, 2018

Primary Completion (ACTUAL)

December 31, 2019

Study Completion (ACTUAL)

December 31, 2019

Study Registration Dates

First Submitted

August 10, 2018

First Submitted That Met QC Criteria

March 3, 2019

First Posted (ACTUAL)

March 5, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 14, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 305/2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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