Paravertebral Block for Percutaneous Radiofrequency Ablation of Liver Lesions

NCT01812577 | Completed DMC

• 1 other identifier: CarGal
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Tumor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Incidence of complications

  From procedure to 24 hours

• Consumption of post-operative opioid

  Within 24 post-operative hours

Other Outcomes (1)

• Satisfaction of patient and of the operator

  From the procedure to 24 hours later.

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• written consent ASA I-III

You may not qualify if:

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

Sponsors & Collaborators

• Campus Bio-Medico University: lead

Study Sites (1)

Campus Bio-Medico

Rome, Italy/RM, 00121, Italy

Location

Related 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. No abstract available.

  PMID: 19143711 BACKGROUND

• 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.

  PMID: 20301827 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Massimiliano Carassiti, MD

  Campus Bio Medico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 8, 2013
• First Posted: March 18, 2013
• Study Start: December 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: September 1, 2022
• Last Updated: August 23, 2024

Record last verified: 2024-08

Locations

IT (1)