Is Thoracic Paravertebral Block a Better Option Than Conscious Sedation for PRFA of Liver Tumors
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 12, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2019
CompletedFirst Submitted
Initial submission to the registry
January 17, 2020
CompletedFirst Posted
Study publicly available on registry
January 27, 2020
CompletedJanuary 27, 2020
January 1, 2020
1.3 years
January 17, 2020
January 22, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (2)
Patients' satisfaction
24 hours post surgery
Surgeon's satisfaction
0 h post surgery (immediately after surgery)
Study Arms (2)
group PVB
EXPERIMENTALstandard analgosedation + paravertebral thoracic blockade with 20 ml 0.25% bupivacaine (Bupivacainum hydrochloricum WZF 0,5%, Polfa warszawa S.A.)
group BB
ACTIVE COMPARATORstandard analgosedation + local anesthesia of the skin and subcutaneous tissue with 5ml 0,5% lignocaine (Lignocainum hydrochlorici, WZF 1%).
Interventions
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.
Local infiltration anaesthesia with 0.5% lignocaine 5ml (Lignocainum hydrochlorici, WZF 1%) was applied to the skin and the potential needle path of ablation.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Anesthesiology and Intensive Care Clinical Ward, Clinical University Hospital
Olsztyn, Warmian-Masurian Voivodeship, 11-041, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ewa Mayzner-Zawadzka, PhD
University of Warmia and Mazury Faculty of Medicine (University Hospital)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 17, 2020
First Posted
January 27, 2020
Study Start
September 9, 2017
Primary Completion
December 12, 2018
Study Completion
August 31, 2019
Last Updated
January 27, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Data will be available within 12 months of study completion
- Access Criteria
- 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.
De-identified study participants data for all primary and secondary outcome measures