Paravertebral Block for Percutaneous Radiofrequency Ablation of Liver Lesions

NCT ID: NCT01812577

Last Updated: 2024-08-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2022-09-30

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.

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Thoracic paravertebral block (TPVB)

Twenty patients receiving thoracic paravertebral block at level of T7, before the interventistic procedure.

No interventions assigned to this group

Deep Sedation (DS)

Twenty patients receiving local and intravenous anesthesia during the procedure.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• written consent ASA I-III

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Campus Bio-Medico University

OTHER

Sponsor Role: lead

Responsible Party

Massimiliano Carassiti

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Massimiliano Carassiti, MD

Role: PRINCIPAL_INVESTIGATOR

Campus Bio Medico

Locations

Campus Bio-Medico

Rome, Italy/RM, Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 19143711 (View on PubMed)

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. doi: 10.1097/aap.0b013e3181c75a8b.

Reference Type: BACKGROUND

PMID: 20301827 (View on PubMed)

Other Identifiers

CarGal

Identifier Type: -

Identifier Source: org_study_id