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Evaluation of the Analgesic Efficacy of the Ultrasound Guided Thoracic Paravertebral Block for Percutaneous Radiofrequency Ablation of Liver Lesions


N/A
18 Years
N/A
Open (Enrolling)
Both
Liver Tumor.

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Trial Information

Evaluation of the Analgesic Efficacy of the Ultrasound Guided Thoracic Paravertebral Block for Percutaneous Radiofrequency Ablation of Liver Lesions


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.


Inclusion Criteria:



- written consent ASA I-III

Exclusion Criteria:

- allergy to local anesthetic infection in the site of planned injection

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

Intensity of postoperative pain after radiofrequency ablation of liver lesion

Outcome Description:

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.

Outcome Time Frame:

first 24 post-operative hours

Safety Issue:

Yes

Principal Investigator

Massimiliano Carassiti, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Campus Bio Medico

Authority:

Italy: Ethics Committee

Study ID:

CarGal

NCT ID:

NCT01812577

Start Date:

December 2012

Completion Date:

December 2013

Related Keywords:

  • Liver Tumor.
  • Liver Neoplasms

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