Aortic Valve Stenosis
Conditions
Keywords
Ilioinguinal Iliohypogastric nerve block, local anaesthesia infiltration, ultrasound-guided, pain control
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)).
Interventions
PROCEDURENerve block
drug mixture: 10-15 ml 0.5% ropivacaine plus 5 ml 1% lidocaine plus 1 mg dexamethasone plus 50 ug adrenaline
PROCEDURELocal infiltration
15-20 ml of mixture of 0.5% bupivacaine and 1% lidocaine (1:1)
PROCEDURETAVI
Insertion of an aortic valve prothesis through the aorta accessed through femoral artery
DRUGAdditional intraoperative analgesia
Administration of any analgesics during the operation
DRUGAdditional postoperative analgesia
Administration of any analgesics within first 24 hours after the operation
Sponsors
Medical University of Gdansk
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Scale (NRS) | 24 hours | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative and postoperative cost calculations | 1 year | Sum of anesthetics and analgesics administered during operation and within first 24 hours after operation |
| Additional intraoperative analgesia consumption | 24 hours | Fentanyl and paracetamol consumption during the operation. |
| Additional postoperative analgesia consumption | 24 hours | Oxycodone and paracetamol consumption in first 24 hours after the operation |
| Patient satisfaction with analgesia | 3 days | Categorical quantification: Yes / No |
Countries
Poland
Outcome results
None listed