Liver TumorNCT04241887
Is Thoracic Paravertebral Block a Better Option Than Conscious Sedation for PRFA of Liver Tumors
A study testing thoracic paravertebral blockade and local anaesthesia in people with Liver Tumor, run by University of Warmia and Mazury at 1 site in Poland.
Trial summary
Percutaneus radiofrequency ablation (RFA) of liver tumors causes acute pain during the periooperative setting. In order to facilitate tumor access, patient should collaborate with a surgeon during the procedurę, therefore should be conscious. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Liver Tumor
- What is being tested?
- thoracic paravertebral blockade and local anaesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePoland
- Study dates
- 9 Sep 2017to 31 Aug 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with primary liver tumor (HCC)
- patient scheduled for an elective surgery
- tumor diameter) <5 cm two tumors <3cm
- Age >18 years
- Physical State 1,2 or 3 of the American Society of Anesthesiology (ASA)
Who cannot join
- ASA IV and V
- Thrombocytopenia (<40x10 ^ 9 / L)
- Severe cirrhosis (Child-Pugh C classification)
- History of psychiatric/cognitive disease
- Patients who do not give informed consent
- Patients with contraindications or history of hypersensitivity to local anaesthesia drugs
- History of chronic pain, chronic opioid use (> 3 months)
Trial locations and contacts
1 site in 1 country.
Poland1 site
Anesthesiology and Intensive Care Clinical Ward, Clinical University Hospital
Olsztyn, Warmian-Masurian Voivodeship, 11-041
About this study
Official title: Is Thoracic Paravertebral Block a Better Option Than Conscious Sedation for Percutaneous Radiofrequency Ablation of Liver Tumors
Percutaneus radiofrequency ablation (RFA) of liver tumors causes acute pain during the periooperative setting. In order to facilitate tumor access, patient should collaborate with a surgeon during the procedurę, therefore should be conscious.
This study aims to assess the impact of a single shot thoracic paravertebral block (TPVB) on a patient's haemodynamic stability, patient's and operator's comfort and satisfaction during the operation and analgesia in the post-operative period.
Read the detailed description
High temperatures used during the percutaneus radiofrequency ablation (PRFA) of liver tumors can cause acute pain in the perioperative setting. In order to facilitate tumor exposure and access, patient should collaborate with a surgeon during the procedurę, therefore should be conscious. It is mandatory to provide an adequate acute postoperative pain control for our patients.
This prospective randomized, single center study was approved by the Bioethics Committee at the University of Warmia and Mazury in Olsztyn, (Poland) under the resolution No. 46/2017.
- Conditions
- Liver Tumor
- Being tested
- thoracic paravertebral blockade, local anaesthesia
- Keywords
- Paravertebral block, Anaesthesia, Analgesia, regional anaesthesia, pain, patient satisfaction, patient comfort, operator satisfaction
- Medical subject headings
- Carcinoma, Hepatocellular, Agnosia, Pain, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thoracic paravertebral blockadeProcedure or surgery
Anesthesia was performed under the ultrasound guidance: the Th8 spinous process was identified, then a probe was moved lateral to medial until two adjacent transverse processes and the pleura were visible. After anaesthetising the skin with 2ml of 1% lignocaine (Lignocainum hydrochlorici, WZF 1%), the Touhy needle 22G (Smith Medical)was introduced under the real time guidance. Once in the paravertebral space, 20ml of 0,25% bupivacaine (Bupivacainum hydrochloricum WZF 0,5%, Polfa Warsaw SA) was injected with an end point of a characteristic pleural displacement.
local anaesthesiaProcedure or surgery
Local infiltration anaesthesia with 0.5% lignocaine 5ml (Lignocainum hydrochlorici, WZF 1%) was applied to the skin and the potential needle path of ablation.
| Study group | Role | What they receive |
|---|---|---|
| group PVB | Experimental | standard analgosedation + paravertebral thoracic blockade with 20 ml 0.25% bupivacaine (Bupivacainum hydrochloricum WZF 0,5%, Polfa warszawa S.A.) Receives: Procedure: thoracic paravertebral blockade |
| group BB | Active comparator | standard analgosedation + local anesthesia of the skin and subcutaneous tissue with 5ml 0,5% lignocaine (Lignocainum hydrochlorici, WZF 1%). Receives: Procedure: local anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of PVB on pain intensity
The level of pain will be assessed in all groups (PVB and BB) basing on the NRS scale (NRS 0- no pain, NRS 10 - the worst pain imaginable) Self reported pain intensity in 5 time points based on the numerical rating scale NRS (where 0 is no pain, 10 is the strongest pain).
comparison of analgesic drug use in both groups
Measured: NRS during the procedure and 0,1,3,6,24 hours post surgery
Effectiveness of PVB on pain intensity
The level of pain will be assessed in all groups (PVB and BB) basing on analgesic drugs consumption
Measured: 0,1,3,6,24 hours post surgery
Secondary outcomes (2)
Patients' satisfaction
Patients' satisfaction will be assessed in all groups (PVB and BB) basing on a survey
Measured: 24 hours post surgery
Surgeon's satisfaction
Surgeon's satisfaction will be assessed in all groups (PVB and BB) basing on a survey (where 0 is no satisfaction, 10-maximal satisfaction)
Measured: 0 h post surgery (immediately after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start9 Sep 2017
- Primary completion12 Dec 2018
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TumorStudies of the same condition, open and under way.
- 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
- Model description
- 30 patients scheduled for an elective Percutaneus Radiofrequency Ablation (PRFA) of a hepatocellular carcinoma were enrolled in the study. Patients were divided in 2 groups: * group PVB - 15 patients under paravertebral block anaesthesia * group BB - 15 patients under local anesthesia, without paravertebral block.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Warmia and Mazury
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Malgorzata Braczkowska, University of Warmia and Mazury
- Investigators
- Ewa Mayzner-Zawadzka, PhD, Study chair, University of Warmia and Mazury Faculty of Medicine (University Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04241887
- Sponsor's protocol ID
- UWarmiaMazury-2
- Status last verified
- Jan 2020
- First submitted
- 17 Jan 2020
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified study participants data for all primary and secondary outcome measures
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Thoracic Paravertebral Block a Better Option Than Conscious Sedation for Percutaneous Radiofrequency Ablation of Liver Tumors
- ClinicalTrials.gov ID
- NCT04241887
- Acronym / sponsor ID
- UWarmiaMazury-2
- Conditions
- Liver Tumor
- Keywords
- Paravertebral block, Anaesthesia, Analgesia, regional anaesthesia, pain, patient satisfaction, patient comfort, operator satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Warmia and MazuryUniversity, hospital or other
- Study start
- 9 Sep 2017 (actual)
- Primary completion
- 12 Dec 2018 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 27 Jan 2020 (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.
Percutaneus radiofrequency ablation (RFA) of liver tumors causes acute pain during the periooperative setting. In order to facilitate tumor access, patient should collaborate with a surgeon during the procedurę, therefore should be conscious.
This study aims to assess the impact of a single shot thoracic paravertebral block (TPVB) on a patient's haemodynamic stability, patient's and operator's comfort and satisfaction during the operation and analgesia in the post-operative period.
Detailed description
High temperatures used during the percutaneus radiofrequency ablation (PRFA) of liver tumors can cause acute pain in the perioperative setting. In order to facilitate tumor exposure and access, patient should collaborate with a surgeon during the procedurę, therefore should be conscious. It is mandatory to provide an adequate acute postoperative pain control for our patients.
This prospective randomized, single center study was approved by the Bioethics Committee at the University of Warmia and Mazury in Olsztyn, (Poland) under the resolution No. 46/2017.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 30 patients scheduled for an elective Percutaneus Radiofrequency Ablation (PRFA) of a hepatocellular carcinoma were enrolled in the study. Patients were divided in 2 groups: * group PVB - 15 patients under paravertebral block anaesthesia * group BB - 15 patients under local anesthesia, without paravertebral block.
| Arm | Type | Receives |
|---|---|---|
| group PVB | Experimental | Procedure: thoracic paravertebral blockadestandard analgosedation + paravertebral thoracic blockade with 20 ml 0.25% bupivacaine (Bupivacainum hydrochloricum WZF 0,5%, Polfa warszawa S.A.) |
| group BB | Active comparator | Procedure: local anaesthesiastandard analgosedation + local anesthesia of the skin and subcutaneous tissue with 5ml 0,5% lignocaine (Lignocainum hydrochlorici, WZF 1%). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients with primary liver tumor (HCC)
- patient scheduled for an elective surgery
- tumor diameter) <5 cm two tumors <3cm
- Age >18 years
- Physical State 1,2 or 3 of the American Society of Anesthesiology (ASA)
Key exclusion criteria (7 listed)
- ASA IV and V
- Thrombocytopenia (<40x10 ^ 9 / L)
- Severe cirrhosis (Child-Pugh C classification)
- History of psychiatric/cognitive disease
- Patients who do not give informed consent
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 |
|---|---|---|
| thoracic paravertebral blockadeAnesthesia was performed under the ultrasound guidance: the Th8 spinous process was identified, then a probe was moved lateral to medial until two adjacent transverse processes and the pleura were visible. After anaesthetising the skin with 2ml of 1% lignocaine (Lignocainum hydrochlorici, WZF 1%), the Touhy needle 22G (Smith Medical)was introduced under the real time guidance. Once in the paravertebral space, 20ml of 0,25% bupivacaine (Bupivacainum hydrochloricum WZF 0,5%, Polfa Warsaw SA) was injected with an end point of a characteristic pleural displacement. | Procedure or surgery | group PVB |
| local anaesthesiaLocal infiltration anaesthesia with 0.5% lignocaine 5ml (Lignocainum hydrochlorici, WZF 1%) was applied to the skin and the potential needle path of ablation. | Procedure or surgery | group BB |
Primary outcome
Effectiveness of PVB on pain intensity
Time frame: NRS during the procedure and 0,1,3,6,24 hours post surgery
The level of pain will be assessed in all groups (PVB and BB) basing on the NRS scale (NRS 0- no pain, NRS 10 - the worst pain imaginable) Self reported pain intensity in 5 time points based on the numerical rating scale NRS (where 0 is no pain, 10 is the strongest pain). comparison of analgesic drug use in both groups
Effectiveness of PVB on pain intensity
Time frame: 0,1,3,6,24 hours post surgery
The level of pain will be assessed in all groups (PVB and BB) basing on analgesic drugs consumption
2 secondary outcomes
Patients' satisfaction
Time frame: 24 hours post surgery
Surgeon's satisfaction
Time frame: 0 h post surgery (immediately after surgery)
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 27 Jan 2020.
- Individual participant dataSharing planned: Yes. De-identified study participants data for all primary and secondary outcome measures
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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.
Ewa Mayzner-Zawadzka, PhD study chair
University of Warmia and Mazury Faculty of Medicine (University Hospital)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thoracic paravertebral blockade and local anaesthesia in people with Liver Tumor, run by University of Warmia and Mazury 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 5 inclusion and 7 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 27 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?
Effectiveness of PVB on pain intensity (time frame: NRS during the procedure and 0,1,3,6,24 hours post surgery). The study lists 2 primary outcomes in all. 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 27 Jan 2020.