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Is Thoracic Paravertebral Block a Better Option Than Conscious Sedation for PRFA of Liver Tumors

Primary Purpose

Liver Tumor

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
thoracic paravertebral blockade
local anaesthesia
Sponsored by
University of Warmia and Mazury
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Tumor focused on measuring Paravertebral block, Anaesthesia, Analgesia, regional anaesthesia, pain, patient satisfaction, patient comfort, operator satisfaction

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Anesthesiology and Intensive Care Clinical Ward, Clinical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

group PVB

group BB

Arm Description

standard analgosedation + paravertebral thoracic blockade with 20 ml 0.25% bupivacaine (Bupivacainum hydrochloricum WZF 0,5%, Polfa warszawa S.A.)

standard analgosedation + local anesthesia of the skin and subcutaneous tissue with 5ml 0,5% lignocaine (Lignocainum hydrochlorici, WZF 1%).

Outcomes

Primary Outcome Measures

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
Effectiveness of PVB on pain intensity
The level of pain will be assessed in all groups (PVB and BB) basing on analgesic drugs consumption

Secondary Outcome Measures

Patients' satisfaction
Patients' satisfaction will be assessed in all groups (PVB and BB) basing on a survey
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)

Full Information

First Posted
January 17, 2020
Last Updated
January 22, 2020
Sponsor
University of Warmia and Mazury
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1. Study Identification

Unique Protocol Identification Number
NCT04241887
Brief Title
Is Thoracic Paravertebral Block a Better Option Than Conscious Sedation for PRFA of Liver Tumors
Official Title
Is Thoracic Paravertebral Block a Better Option Than Conscious Sedation for Percutaneous Radiofrequency Ablation of Liver Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 9, 2017 (Actual)
Primary Completion Date
December 12, 2018 (Actual)
Study Completion Date
August 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Warmia and Mazury

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Tumor
Keywords
Paravertebral block, Anaesthesia, Analgesia, regional anaesthesia, pain, patient satisfaction, patient comfort, operator satisfaction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
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.
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group PVB
Arm Type
Experimental
Arm Description
standard analgosedation + paravertebral thoracic blockade with 20 ml 0.25% bupivacaine (Bupivacainum hydrochloricum WZF 0,5%, Polfa warszawa S.A.)
Arm Title
group BB
Arm Type
Active Comparator
Arm Description
standard analgosedation + local anesthesia of the skin and subcutaneous tissue with 5ml 0,5% lignocaine (Lignocainum hydrochlorici, WZF 1%).
Intervention Type
Procedure
Intervention Name(s)
thoracic paravertebral blockade
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
local anaesthesia
Intervention Description
Local infiltration anaesthesia with 0.5% lignocaine 5ml (Lignocainum hydrochlorici, WZF 1%) was applied to the skin and the potential needle path of ablation.
Primary Outcome Measure Information:
Title
Effectiveness of PVB on pain intensity
Description
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
Time Frame
NRS during the procedure and 0,1,3,6,24 hours post surgery
Title
Effectiveness of PVB on pain intensity
Description
The level of pain will be assessed in all groups (PVB and BB) basing on analgesic drugs consumption
Time Frame
0,1,3,6,24 hours post surgery
Secondary Outcome Measure Information:
Title
Patients' satisfaction
Description
Patients' satisfaction will be assessed in all groups (PVB and BB) basing on a survey
Time Frame
24 hours post surgery
Title
Surgeon's satisfaction
Description
Surgeon's satisfaction will be assessed in all groups (PVB and BB) basing on a survey (where 0 is no satisfaction, 10-maximal satisfaction)
Time Frame
0 h post surgery (immediately after surgery)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ewa Mayzner-Zawadzka, PhD
Organizational Affiliation
University of Warmia and Mazury Faculty of Medicine (University Hospital)
Official's Role
Study Chair
Facility Information:
Facility Name
Anesthesiology and Intensive Care Clinical Ward, Clinical University Hospital
City
Olsztyn
State/Province
Warmian-masurian
ZIP/Postal Code
11-041
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified study participants data for all primary and secondary outcome measures
IPD Sharing Time Frame
Data will be available within 12 months of study completion
IPD Sharing 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.

Learn more about this trial

Is Thoracic Paravertebral Block a Better Option Than Conscious Sedation for PRFA of Liver Tumors

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