Aortic Valve StenosisTF-TAVINCT03863899
Analgesia in Patients Undergoing Transfemoral Transcatheter Aortic Valve Implantation (TF-TAVI)
A study testing Nerve block, Local infiltration and TAVI in people with Aortic Valve Stenosis, run by Medical University of Gdansk at 1 site in Poland.
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Nerve block, Local infiltration and TAVI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 2 Jul 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- patients with aortic valve stenosis referred for TF-TAVI
- using a minimalist approach of local anesthesia or nerve block with conscious sedation
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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
- Being tested
- Nerve block, Local infiltration, TAVI, Additional intraoperative analgesia, Additional postoperative analgesia
- Keywords
- Ilioinguinal Iliohypogastric nerve block, local anaesthesia infiltration, ultrasound-guided, pain control
- Medical subject headings
- Aortic Valve Stenosis, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve blockProcedure or surgery
Also called Ultrasound-guided ilioinguinal iliohypogastric nerve block
drug mixture: 10-15 ml 0.5% ropivacaine plus 5 ml 1% lidocaine plus 1 mg dexamethasone plus 50 ug adrenaline
Local infiltrationProcedure or surgery
Also called Local anesthesia infiltration
15-20 ml of mixture of 0.5% bupivacaine and 1% lidocaine (1:1)
TAVIProcedure or surgery
Also called Transaortic valve implantation
Insertion of an aortic valve prothesis through the aorta accessed through femoral artery
Additional intraoperative analgesiaDrug
Also called AIA
Administration of any analgesics during the operation
Additional postoperative analgesiaDrug
Also called APA
Administration of any analgesics within first 24 hours after the operation
| Study group | Role | What they receive |
|---|---|---|
| Nerve block | Experimental | 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) Receives: Procedure: Nerve block; Procedure: TAVI; Drug: Additional intraoperative analgesia; Drug: Additional postoperative analgesia |
| Local infiltration | Active comparator | local anaesthesia infiltration performed by the operator for TAVI insertion with eventual intraoperative additional analgesia (AIA) and/or postoperative analgesia (APA) Receives: Procedure: Local infiltration; Procedure: TAVI; Drug: Additional intraoperative analgesia; Drug: Additional postoperative analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 24 hours
Secondary outcomes (4)
Additional intraoperative analgesia consumption
Fentanyl and paracetamol consumption during the operation.
Measured: 24 hours
Additional postoperative analgesia consumption
Oxycodone and paracetamol consumption in first 24 hours after the operation
Measured: 24 hours
Patient satisfaction with analgesia
Categorical quantification: Yes / No
Measured: 3 days
Intraoperative and postoperative cost calculations
Sum of anesthetics and analgesics administered during operation and within first 24 hours after operation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start2 Jul 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liudmila Hasak, MD, PhD, Medical University of Gdansk
- Investigators
- Romuald Lango, MD, PhD, Study chair, Department of Cardiac Anaesthesiolgy UCC of Gdansk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03863899
- Sponsor's protocol ID
- 305/2018
- Acronym
- TF-TAVI
- Status last verified
- Jan 2020
- First submitted
- 10 Aug 2018
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03863899
- Acronym / sponsor ID
- TF-TAVI / 305/2018
- Conditions
- Aortic Valve Stenosis
- Keywords
- Ilioinguinal Iliohypogastric nerve block, local anaesthesia infiltration, ultrasound-guided, pain control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 5 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nerve block | Experimental | Procedure: Nerve block, Procedure: TAVI, Drug: Additional intraoperative analgesia, Drug: Additional postoperative analgesiaultrasound-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) |
| Local infiltration | Active comparator | Procedure: Local infiltration, Procedure: TAVI, Drug: Additional intraoperative analgesia, Drug: Additional postoperative analgesialocal anaesthesia infiltration performed by the operator for TAVI insertion with eventual intraoperative additional analgesia (AIA) and/or postoperative analgesia (APA) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- patients with aortic valve stenosis referred for TF-TAVI
- using a minimalist approach of local anesthesia or nerve block with conscious sedation
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nerve blockAlso: Ultrasound-guided ilioinguinal iliohypogastric nerve blockdrug mixture: 10-15 ml 0.5% ropivacaine plus 5 ml 1% lidocaine plus 1 mg dexamethasone plus 50 ug adrenaline | Procedure or surgery | Nerve block |
| Local infiltrationAlso: Local anesthesia infiltration15-20 ml of mixture of 0.5% bupivacaine and 1% lidocaine (1:1) | Procedure or surgery | Local infiltration |
| TAVIAlso: Transaortic valve implantationInsertion of an aortic valve prothesis through the aorta accessed through femoral artery | Procedure or surgery | Local infiltration, Nerve block |
| Additional intraoperative analgesiaAlso: AIAAdministration of any analgesics during the operation | Drug | Local infiltration, Nerve block |
| Additional postoperative analgesiaAlso: APAAdministration of any analgesics within first 24 hours after the operation | Drug | Local infiltration, Nerve block |
Primary outcome
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).
4 secondary outcomes
Additional intraoperative analgesia consumption
Time frame: 24 hours
Additional postoperative analgesia consumption
Time frame: 24 hours
Patient satisfaction with analgesia
Time frame: 3 days
Intraoperative and postoperative cost calculations
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Romuald Lango, MD, PhD study chair
Department of Cardiac Anaesthesiolgy UCC of Gdansk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nerve block, Local infiltration and TAVI in people with Aortic Valve Stenosis, run by Medical University of Gdansk at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale (NRS) (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.