Clinical trial NCT01812577: Paravertebral Block for Percutaneous Radiofrequency Ablation of Liver Lesions
Official title: Evaluation of the Analgesic Efficacy of the Ultrasound Guided Thoracic Paravertebral Block for Percutaneous Radiofrequency Ablation of Liver Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Tumor
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2013-03-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

* written consent ASA I-III

Exclusion Criteria:

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

Primary outcomes:
measure: Intensity of postoperative pain after radiofrequency ablation of liver lesion
timeFrame: first 24 post-operative hours
Secondary outcomes:
measure: Incidence of complications
timeFrame: From procedure to 24 hours
measure: Consumption of post-operative opioid
timeFrame: Within 24 post-operative hours
Other outcomes:
measure: Satisfaction of patient and of the operator
timeFrame: From the procedure to 24 hours later.
Locations:
city: Rome
country: Italy
facility: Campus Bio-Medico
state: Italy/RM
Study officials:
affiliation: Campus Bio Medico
name: Massimiliano Carassiti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1097/aap.0b013e3181c75a8b.