Clinical trial NCT03863899: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Stenosis
Keywords: Ilioinguinal Iliohypogastric nerve block
local anaesthesia infiltration
ultrasound-guided
pain control
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
First posted: 2019-03-05
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)).

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).

Primary outcomes:
measure: Numeric Rating Scale (NRS)
timeFrame: 24 hours
Secondary outcomes:
measure: Additional intraoperative analgesia consumption
timeFrame: 24 hours
measure: Additional postoperative analgesia consumption
timeFrame: 24 hours
measure: Patient satisfaction with analgesia
timeFrame: 3 days
measure: Intraoperative and postoperative cost calculations
timeFrame: 1 year
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: University Clinical Centre
Study officials:
affiliation: Department of Cardiac Anaesthesiolgy UCC of Gdansk
name: Romuald Lango, MD, PhD
role: STUDY_CHAIR
References: