Liver TumorTPVBNCT01812577
Paravertebral Block for Percutaneous Radiofrequency Ablation of Liver Lesions
An observational study of Liver Tumor, run by Campus Bio-Medico University at 1 site in Italy.
Trial summary
Percutaneous radiofrequency ablation of liver lesions causes patients acute pain during and after the procedure. During the procedure patients need deep sedation and cannot be collaborative. Furthermore post-operative analgesia is necessary. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Tumor
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2012to Sep 2022
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In this study 40 patients undergoing elective procedure of radiofrequency ablation of liver lesions are enrolled after written informed consent is obtained.
Who may be able to join
- written consent ASA I-III
Who cannot join
- allergy to local anesthetic infection in the site of planned injection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Analgesic Efficacy of the Ultrasound Guided Thoracic Paravertebral Block for Percutaneous Radiofrequency Ablation of Liver Lesions
Percutaneous radiofrequency ablation of liver lesions causes patients acute pain during and after the procedure. During the procedure patients need deep sedation and cannot be collaborative. Furthermore post-operative analgesia is necessary. The aim of this study is to evaluate if the ultrasound-guided paravertebral block (TPVB)with a single injection can provide anesthesia and post-operative analgesia in these patients.
Read the detailed description
The purpose of this study is to evaluate if single injection TPVB, ultrasound guided, ENS assisted, is advantageous compared to deep sedation (DS)in patients undergoing percutaneous radiofrequency ablation of liver lesions with respect to post-operative analgesia (at rest and in movement)and vomiting. Furthermore we collect data on operator and patient satisfaction.
In this study patients are randomly divided into two groups (20 patient each): TPVB and DS. In TPVB group the block is performed in lateral position at level of T7 with bupivacaine 5mg/ml. In DS group the procedure is conducted under local and intravenous anesthesia, and a post-operative analgesia is assigned. Data on patient, on procedures (duration, number and position of lesions etc.), complications with the anesthesiological technique are collected. The intensity of post-operative pain is assessed at 3-6-12 and 24 hours after procedure in both group using VRS pain scale at rest and in movement. Any concomitant event like nausea, vomiting, respiratory complications etc are recorded.
- Conditions
- Liver Tumor
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Thoracic paravertebral block (TPVB) | Twenty patients receiving thoracic paravertebral block at level of T7, before the interventistic procedure. | |
| Deep Sedation (DS) | Twenty patients receiving local and intravenous anesthesia during the procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of postoperative pain after radiofrequency ablation of liver lesion
Intensity of postoperative pain after radiofrequency ablation of liver lesion is evaluated in both groups using VRS of pain at rest and in movement after 3-6-12-24 hours from procedure.
Measured: first 24 post-operative hours
Secondary outcomes (2)
Incidence of complications
We record immediate complication such as PNX, vascular puncture etc, and post-operative complications such as nausea, vomiting, hypotension, etc, in both groups
Measured: From procedure to 24 hours
Consumption of post-operative opioid
We evaluate if there is differences in consumption of opioid in the two groups
Measured: Within 24 post-operative hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2013
- Study completionSep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Campus Bio-Medico University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimiliano Carassiti, Campus Bio-Medico University
- Investigators
- Massimiliano Carassiti, MD, Principal investigator, Campus Bio Medico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01812577
- Sponsor's protocol ID
- CarGal
- Acronym
- TPVB
- Status last verified
- Aug 2024
- First submitted
- 8 Mar 2013
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hara K, Sakura S, Nomura T, Saito Y. Ultrasound guided thoracic paravertebral block in breast surgery. Anaesthesia. 2009 Feb;64(2):223-5. doi: 10.1111/j.1365-2044.2008.05843.x. No abstract available.
PubMed 19143711Renes SH, Bruhn J, Gielen MJ, Scheffer GJ, van Geffen GJ. In-plane ultrasound-guided thoracic paravertebral block: a preliminary report of 36 cases with radiologic confirmation of catheter position. Reg Anesth Pain Med. 2010 Mar-Apr;35(2):212-6. doi: 10.1097/aap.0b013e3181c75a8b.
PubMed 20301827
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Analgesic Efficacy of the Ultrasound Guided Thoracic Paravertebral Block for Percutaneous Radiofrequency Ablation of Liver Lesions
- ClinicalTrials.gov ID
- NCT01812577
- Acronym / sponsor ID
- TPVB / CarGal
- Conditions
- Liver Tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Campus Bio-Medico UniversityUniversity, hospital or other
- Study start
- Dec 2012 (actual)
- Primary completion
- Dec 2013 (actual)
- Study completion
- Sep 2022 (actual)
- First posted
- 18 Mar 2013 (estimated)
- 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.
Percutaneous radiofrequency ablation of liver lesions causes patients acute pain during and after the procedure. During the procedure patients need deep sedation and cannot be collaborative. Furthermore post-operative analgesia is necessary. The aim of this study is to evaluate if the ultrasound-guided paravertebral block (TPVB)with a single injection can provide anesthesia and post-operative analgesia in these patients.
Detailed description
The purpose of this study is to evaluate if single injection TPVB, ultrasound guided, ENS assisted, is advantageous compared to deep sedation (DS)in patients undergoing percutaneous radiofrequency ablation of liver lesions with respect to post-operative analgesia (at rest and in movement)and vomiting. Furthermore we collect data on operator and patient satisfaction.
In this study patients are randomly divided into two groups (20 patient each): TPVB and DS. In TPVB group the block is performed in lateral position at level of T7 with bupivacaine 5mg/ml. In DS group the procedure is conducted under local and intravenous anesthesia, and a post-operative analgesia is assigned. Data on patient, on procedures (duration, number and position of lesions etc.), complications with the anesthesiological technique are collected. The intensity of post-operative pain is assessed at 3-6-12 and 24 hours after procedure in both group using VRS pain scale at rest and in movement. Any concomitant event like nausea, vomiting, respiratory complications etc are recorded.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracic paravertebral block (TPVB) | – | –Twenty patients receiving thoracic paravertebral block at level of T7, before the interventistic procedure. |
| Deep Sedation (DS) | – | –Twenty patients receiving local and intravenous anesthesia during the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In this study 40 patients undergoing elective procedure of radiofrequency ablation of liver lesions are enrolled after written informed consent is obtained.
Key inclusion criteria (1 listed)
- written consent ASA I-III
Key exclusion criteria (1 listed)
- allergy to local anesthetic infection in the site of planned injection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intensity of postoperative pain after radiofrequency ablation of liver lesion
Time frame: first 24 post-operative hours
Intensity of postoperative pain after radiofrequency ablation of liver lesion is evaluated in both groups using VRS of pain at rest and in movement after 3-6-12-24 hours from procedure.
2 secondary outcomes
Incidence of complications
Time frame: From procedure to 24 hours
Consumption of post-operative opioid
Time frame: Within 24 post-operative hours
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 23 Aug 2024.
- Background: PubMed 19143711Hara K, Sakura S, Nomura T, Saito Y. Ultrasound guided thoracic paravertebral block in breast surgery. Anaesthesia. 2009 Feb;64(2):223-5. doi: 10.1111/j.1365-2044.2008.05843.x. No abstract available.
- Background: PubMed 20301827Renes SH, Bruhn J, Gielen MJ, Scheffer GJ, van Geffen GJ. In-plane ultrasound-guided thoracic paravertebral block: a preliminary report of 36 cases with radiologic confirmation of catheter position. Reg Anesth Pain Med. 2010 Mar-Apr;35(2):212-6. doi: 10.1097/aap.0b013e3181c75a8b.
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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.
Massimiliano Carassiti, MD principal investigator
Campus Bio Medico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Tumor, run by Campus Bio-Medico University at 1 site in Italy.
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 1 inclusion and 1 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 23 Aug 2024. 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 Italy. 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?
Intensity of postoperative pain after radiofrequency ablation of liver lesion (time frame: first 24 post-operative hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01812577, which also lists 2 linked publications.
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 23 Aug 2024.