- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02271646
Ultrasound Guided Thoracic Paravertebral Block for Hepatic Tumors Ablation
Ultrasound Guided Thoracic Paravertebral Blocks: An Effective Pain Control in Percutaneous Radiofrequency Ablation of Hepatic Tumors
Patients undergo percutaneous radiofrequency ablation of hepatic tumors at Siriraj hospital normally receive only intravenous sedative drugs which sometimes can not provide effective pain control.
TPVB is suitable for unilateral operations. And it is increasing popular nowadays because of using ultrasound guided which make it is more reliable and has less side effects especially the severe one such as pneumothorax. To cover all nerve supply liver, we decided to use right TPVB at T5-6, T7-8, and T9-10.
The aim of this study is to prove that TPVB can provide an effective pain control for patients undergo liver RFA both at rest and movement (cough). We are going to measure the pain score at recovery room and the effective pain control means patients has mild pain (pain score less </= 3 and do not ask for analgesic drugs).
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bangkok, Thailand, 10700
- Siriraj Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age > 18 years
- Patients undergo percutaneous radiofrequency ablation for liver tumors
- ASA classification 1-3
Exclusion Criteria:
- Psychiatric illness
- Chronic abdominal pain > 1 week
- Regular analgesic drugs use
- Infection at back (Block area)
- Severe spinal deformity
- PT > 16 sec, aPTT > 32, platelet < 50,000/cumm
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 0.5% marcaine 20ml
3 levels ultrasound guided thoracic paravertebral blocks at T5-6, T7-8 and T9-10 (total 0.5% marcaine 20ml)
|
3 levels ultrasound guided thoracic paravertebral block at T5-6, T7-8 and T9-10 (total 0.5% marcaine 20ml)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pain score at recovery room both at rest and movement (cough)
Time Frame: Up to 24 hours
|
All patients at recovery room has mild pain (pain score </= 3) and do not need any rescue analgesic drugs.
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Up to 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Distribution of local anesthetic drugs after performing ultrasound guided TPVB at T5-6, T7-8 and T9-10.
Time Frame: After performing TPVB at 5, 10, 20 and 30 minutes.
|
Test with cold sensation.
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After performing TPVB at 5, 10, 20 and 30 minutes.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Pawinee Pangthipampai, M.D., Mahidol University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 070/2557(EC2)
- (IO) R015731063 (Other Grant/Funding Number: Faculty of medicine, Siriraj hospital, Mahidol university)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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