Liver Tumor
Conditions
Keywords
Paravertebral block, Anaesthesia, Analgesia, regional anaesthesia, pain, patient satisfaction, patient comfort, operator satisfaction
Brief summary
Percutaneus radiofrequency ablation (RFA) of liver tumors causes acute pain during the periooperative setting. In order to facilitate tumor access, patient should collaborate with a surgeon during the procedurę, therefore should be conscious. This study aims to assess the impact of a single shot thoracic paravertebral block (TPVB) on a patient's haemodynamic stability, patient's and operator's comfort and satisfaction during the operation and analgesia in the post-operative period.
Detailed description
High temperatures used during the percutaneus radiofrequency ablation (PRFA) of liver tumors can cause acute pain in the perioperative setting. In order to facilitate tumor exposure and access, patient should collaborate with a surgeon during the procedurę, therefore should be conscious. It is mandatory to provide an adequate acute postoperative pain control for our patients. This prospective randomized, single center study was approved by the Bioethics Committee at the University of Warmia and Mazury in Olsztyn, (Poland) under the resolution No. 46/2017.
Interventions
PROCEDUREthoracic paravertebral blockade
Anesthesia was performed under the ultrasound guidance: the Th8 spinous process was identified, then a probe was moved lateral to medial until two adjacent transverse processes and the pleura were visible. After anaesthetising the skin with 2ml of 1% lignocaine (Lignocainum hydrochlorici, WZF 1%), the Touhy needle 22G (Smith Medical)was introduced under the real time guidance. Once in the paravertebral space, 20ml of 0,25% bupivacaine (Bupivacainum hydrochloricum WZF 0,5%, Polfa Warsaw SA) was injected with an end point of a characteristic pleural displacement.
PROCEDURElocal anaesthesia
Local infiltration anaesthesia with 0.5% lignocaine 5ml (Lignocainum hydrochlorici, WZF 1%) was applied to the skin and the potential needle path of ablation.
Sponsors
University of Warmia and Mazury
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants were randomly assigned into 2 groups (computerized randomization program). group PVB - patients under paravertebral block anesthesia, group BB - patients under local anesthesia, without paravertebral block.
Intervention model description
30 patients scheduled for an elective Percutaneus Radiofrequency Ablation (PRFA) of a hepatocellular carcinoma were enrolled in the study. Patients were divided in 2 groups: * group PVB - 15 patients under paravertebral block anaesthesia * group BB - 15 patients under local anesthesia, without paravertebral block.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* patients with primary liver tumor (HCC) * patient scheduled for an elective surgery * tumor diameter) \<5 cm two tumors \<3cm * Age \>18 years * Physical State 1,2 or 3 of the American Society of Anesthesiology (ASA)
Exclusion criteria
* ASA IV and V * Thrombocytopenia (\<40x10 \^ 9 / L) * Severe cirrhosis (Child-Pugh C classification) * History of psychiatric/cognitive disease * Patients who do not give informed consent * Patients with contraindications or history of hypersensitivity to local anaesthesia drugs * History of chronic pain, chronic opioid use (\> 3 months)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of PVB on pain intensity | NRS during the procedure and 0,1,3,6,24 hours post surgery | The level of pain will be assessed in all groups (PVB and BB) basing on the NRS scale (NRS 0- no pain, NRS 10 - the worst pain imaginable) Self reported pain intensity in 5 time points based on the numerical rating scale NRS (where 0 is no pain, 10 is the strongest pain). comparison of analgesic drug use in both groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients' satisfaction | 24 hours post surgery | Patients' satisfaction will be assessed in all groups (PVB and BB) basing on a survey |
| Surgeon's satisfaction | 0 h post surgery (immediately after surgery) | Surgeon's satisfaction will be assessed in all groups (PVB and BB) basing on a survey (where 0 is no satisfaction, 10-maximal satisfaction) |
Countries
Poland
Outcome results
None listed