NCT03863899

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Medical University of Gdansk · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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)).

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-07-02
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2019-03-05
• Last updated: 2020-01-18

Locations

1 site across 1 country: Poland