Is Thoracic Paravertebral Block a Better Option Than Conscious Sedation for Percutaneous Radiofrequency Ablation of Liver Tumors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Effectiveness of PVB on pain intensity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (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.
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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)
Arms & Interventions
group PVB
standard analgosedation + paravertebral thoracic blockade with 20 ml 0.25% bupivacaine (Bupivacainum hydrochloricum WZF 0,5%, Polfa warszawa S.A.)
Intervention: thoracic paravertebral blockade (Procedure)
group BB
standard analgosedation + local anesthesia of the skin and subcutaneous tissue with 5ml 0,5% lignocaine (Lignocainum hydrochlorici, WZF 1%).
Intervention: local anaesthesia (Procedure)
Outcomes
Primary Outcomes
Effectiveness of PVB on pain intensity
Time Frame: 0,1,3,6,24 hours post surgery
The level of pain will be assessed in all groups (PVB and BB) basing on analgesic drugs consumption
Effectiveness of PVB on pain intensity
Time Frame: 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 Outcomes
- Patients' satisfaction(24 hours post surgery)
- Surgeon's satisfaction(0 h post surgery (immediately after surgery))
Investigators
Malgorzata Braczkowska
Principal Investigator
University of Warmia and Mazury