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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 procedurÄ™, 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.
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 procedurÄ™, 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group PVB | Experimental | standard analgosedation + paravertebral thoracic blockade with 20 ml 0.25% bupivacaine (Bupivacainum hydrochloricum WZF 0,5%, Polfa warszawa S.A.) |
|
| group BB | Active Comparator | standard analgosedation + local anesthesia of the skin and subcutaneous tissue with 5ml 0,5% lignocaine (Lignocainum hydrochlorici, WZF 1%). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| thoracic paravertebral blockade | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of PVB on pain intensity | 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 | NRS during the procedure and 0,1,3,6,24 hours post surgery |
| Effectiveness of PVB on pain intensity | The level of pain will be assessed in all groups (PVB and BB) basing on analgesic drugs consumption | 0,1,3,6,24 hours post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Patients' satisfaction | Patients' satisfaction will be assessed in all groups (PVB and BB) basing on a survey | 24 hours post surgery |
| Surgeon's satisfaction | Surgeon's satisfaction will be assessed in all groups (PVB and BB) basing on a survey (where 0 is no satisfaction, 10-maximal satisfaction) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ewa Mayzner-Zawadzka, PhD | University of Warmia and Mazury Faculty of Medicine (University Hospital) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anesthesiology and Intensive Care Clinical Ward, Clinical University Hospital | Olsztyn | Warmian-Masurian Voivodeship | 11-041 | Poland |
De-identified study participants data for all primary and secondary outcome measures
Data will be available within 12 months of study completion
Data will be made available for researchers who provide a methodologically sound proposal. Proposals should be directed to m.braczkowska@gmail.com . Data access requests will be reviewed by an External Independent Review Panel. To gain access, data requestors will need to sign a data access agreement.
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D000377 | Agnosia |
| D010146 | Pain |
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000772 | Anesthesia, Local |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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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:
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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.
|
| local anaesthesia | Procedure | Local infiltration anaesthesia with 0.5% lignocaine 5ml (Lignocainum hydrochlorici, WZF 1%) was applied to the skin and the potential needle path of ablation. |
|
| 0 h post surgery (immediately after surgery) |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |