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

Aortic Valve Stenosis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03863899
• Other study ID #: 305/2018
• Status: Completed
• Phase: N/A
• Start date: July 2, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2020
• Source: Medical University of Gdansk
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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)).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

Procedure:
• Nerve block
drug mixture: 10-15 ml 0.5% ropivacaine plus 5 ml 1% lidocaine plus 1 mg dexamethasone plus 50 ug adrenaline
• Local infiltration
15-20 ml of mixture of 0.5% bupivacaine and 1% lidocaine (1:1)
• 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
• Additional postoperative analgesia
Administration of any analgesics within first 24 hours after the operation

Locations

Country	Name	City	State
Poland	University Clinical Centre	Gdansk

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Gdansk

Country where clinical trial is conducted

Poland, 

Outcome

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