Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Paravertebral Block for Percutaneous Radiofrequency Ablation of Liver Lesions (TPVB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01812577
Recruitment Status : Enrolling by invitation
First Posted : March 18, 2013
Last Update Posted : February 1, 2021
Sponsor:
Information provided by (Responsible Party):
Massimiliano Carassiti, Campus Bio-Medico University

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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. 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.

Condition or disease
Liver Tumor

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Evaluation of the Analgesic Efficacy of the Ultrasound Guided Thoracic Paravertebral Block for Percutaneous Radiofrequency Ablation of Liver Lesions
Study Start Date : December 2012
Actual Primary Completion Date : December 2013
Estimated Study Completion Date : September 2022
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Incidence of complications [ Time Frame: From procedure to 24 hours ]
    We record immediate complication such as PNX, vascular puncture etc, and post-operative complications such as nausea, vomiting, hypotension, etc, in both groups

  2. Consumption of post-operative opioid [ Time Frame: Within 24 post-operative hours ]
    We evaluate if there is differences in consumption of opioid in the two groups


Other Outcome Measures:
  1. Satisfaction of patient and of the operator [ Time Frame: From the procedure to 24 hours later. ]
    We collect data on operator satisfaction during the procedure, and patients satisfaction at 24 hours after procedure


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
In this study 40 patients undergoing elective procedure of radiofrequency ablation of liver lesions are enrolled after written informed consent is obtained.
Criteria

Inclusion Criteria:

  • written consent ASA I-III

Exclusion Criteria:

  • allergy to local anesthetic infection in the site of planned injection
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01812577


Locations
Layout table for location information
Italy
Campus Bio-Medico
Rome, Italy/RM, Italy, 00121
Sponsors and Collaborators
Campus Bio-Medico University
Investigators
Layout table for investigator information
Principal Investigator: Massimiliano Carassiti, MD Campus Bio Medico
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Massimiliano Carassiti, MD, Campus Bio-Medico University
ClinicalTrials.gov Identifier: NCT01812577    
Other Study ID Numbers: CarGal
First Posted: March 18, 2013    Key Record Dates
Last Update Posted: February 1, 2021
Last Verified: January 2021
Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Liver Diseases