Liver Tumor
Conditions
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.
Interventions
None listed
Sponsors
Campus Bio-Medico University
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* written consent ASA I-III
Exclusion criteria
* allergy to local anesthetic infection in the site of planned injection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intensity of postoperative pain after radiofrequency ablation of liver lesion | first 24 post-operative hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of complications | From procedure to 24 hours | We record immediate complication such as PNX, vascular puncture etc, and post-operative complications such as nausea, vomiting, hypotension, etc, in both groups |
| Consumption of post-operative opioid | Within 24 post-operative hours | We evaluate if there is differences in consumption of opioid in the two groups |
Other
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction of patient and of the operator | From the procedure to 24 hours later. | We collect data on operator satisfaction during the procedure, and patients satisfaction at 24 hours after procedure |
Countries
Italy
Outcome results
None listed