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

NCT03863899 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-01-18

No results posted yet for this study

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

Interventions

PROCEDURE

Nerve block

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

PROCEDURE

Local infiltration

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

PROCEDURE

TAVI

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

DRUG

Additional intraoperative analgesia

Administration of any analgesics during the operation

DRUG

Additional postoperative analgesia

Administration of any analgesics within first 24 hours after the operation

Sponsors & Collaborators

  • Medical University of Gdansk

    lead OTHER

Principal Investigators

  • Romuald Lango, MD, PhD · Department of Cardiac Anaesthesiolgy UCC of Gdansk

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-02
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03863899 on ClinicalTrials.gov