Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Consumption of post-operative opioid |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
In this study 40 patients undergoing elective procedure of radiofrequency ablation of liver lesions are enrolled after written informed consent is obtained.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Massimiliano Carassiti, MD | Campus Bio Medico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Campus Bio-Medico | Rome | Italy/RM | 00121 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19143711 | Background | 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. | |
| 20301827 | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
Not provided
Not provided
Not provided
We evaluate if there is differences in consumption of opioid in the two groups |
| Within 24 post-operative hours |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |