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
Overview
- Phase
- Not Applicable
- Intervention
- Nerve block
- Conditions
- Aortic Valve Stenosis
- Sponsor
- Medical University of Gdansk
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Numeric Rating Scale (NRS)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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)).
Investigators
Liudmila Hasak, MD, PhD
Principal Investigator
Medical University of Gdansk
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).
Arms & Interventions
Nerve block
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)
Intervention: Nerve block
Nerve block
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)
Intervention: TAVI
Nerve block
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)
Intervention: Additional intraoperative analgesia
Nerve block
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)
Intervention: Additional postoperative analgesia
Local infiltration
local anaesthesia infiltration performed by the operator for TAVI insertion with eventual intraoperative additional analgesia (AIA) and/or postoperative analgesia (APA)
Intervention: Local infiltration
Local infiltration
local anaesthesia infiltration performed by the operator for TAVI insertion with eventual intraoperative additional analgesia (AIA) and/or postoperative analgesia (APA)
Intervention: TAVI
Local infiltration
local anaesthesia infiltration performed by the operator for TAVI insertion with eventual intraoperative additional analgesia (AIA) and/or postoperative analgesia (APA)
Intervention: Additional intraoperative analgesia
Local infiltration
local anaesthesia infiltration performed by the operator for TAVI insertion with eventual intraoperative additional analgesia (AIA) and/or postoperative analgesia (APA)
Intervention: Additional postoperative analgesia
Outcomes
Primary Outcomes
Numeric Rating Scale (NRS)
Time Frame: 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 Outcomes
- Additional intraoperative analgesia consumption(24 hours)
- Additional postoperative analgesia consumption(24 hours)
- Patient satisfaction with analgesia(3 days)
- Intraoperative and postoperative cost calculations(1 year)