Paravertebral Block for Percutaneous Radiofrequency Ablation of Liver Lesions

Liver Tumor Clinical Trial

— TPVB  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01812577
• Other study ID #: CarGal
• Status: Enrolling by invitation
• Start date: December 2012
• Est. completion date: September 2022

Study information

• Verified date: January 2021
• Source: Campus Bio-Medico University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: September 2022
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• written consent ASA I-III

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Liver Neoplasms
• Liver Tumor

Locations

Country	Name	City	State
Italy	Campus Bio-Medico	Rome	Italy/RM

Sponsors (1)

Lead Sponsor	Collaborator
Campus Bio-Medico University

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View Citation

Renes 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Satisfaction of patient and of the operator	We collect data on operator satisfaction during the procedure, and patients satisfaction at 24 hours after procedure	From the procedure to 24 hours later.
Primary	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.	first 24 post-operative hours
Secondary	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	From procedure to 24 hours
Secondary	Consumption of post-operative opioid	We evaluate if there is differences in consumption of opioid in the two groups	Within 24 post-operative hours