Brief Title
Analgesia in Patients Undergoing Transfemoral Transcatheter Aortic Valve Implantation (TF-TAVI)
Official 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
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 Type
Interventional
Primary Outcome
Numeric Rating Scale (NRS)
Secondary Outcome
Additional intraoperative analgesia consumption
Condition
Aortic Valve Stenosis
Intervention
Nerve block
Study Arms / Comparison Groups
Nerve block
Description: 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)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
100
Start Date
July 2, 2018
Completion Date
December 31, 2019
Primary Completion Date
December 31, 2019
Eligibility Criteria
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).
Gender
All
Ages
65 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Romuald Lango, MD, PhD, ,
Location Countries
Poland
Location Countries
Poland
Administrative Informations
NCT ID
NCT03863899
Organization ID
305/2018
Responsible Party
Principal Investigator
Study Sponsor
Medical University of Gdansk
Study Sponsor
Romuald Lango, MD, PhD, Study Chair, Department of Cardiac Anaesthesiolgy UCC of Gdansk
Verification Date
January 2020