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Ultrasound Guided Thoracic Paravertebral Block for Hepatic Tumors Ablation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02271646
Recruitment Status : Completed
First Posted : October 22, 2014
Last Update Posted : March 12, 2019
Sponsor:
Collaborator:
Siriraj Hospital
Information provided by (Responsible Party):
Mahidol University

Brief Summary:

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).


Condition or disease Intervention/treatment Phase
Liver Cancer Drug: 0.5% marcaine 20ml Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Ultrasound Guided Thoracic Paravertebral Blocks: An Effective Pain Control in Percutaneous Radiofrequency Ablation of Hepatic Tumors
Study Start Date : August 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


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)
Drug: 0.5% marcaine 20ml
3 levels ultrasound guided thoracic paravertebral block at T5-6, T7-8 and T9-10 (total 0.5% marcaine 20ml)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02271646


Locations
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Thailand
Siriraj hospital
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Siriraj Hospital
Investigators
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Principal Investigator: Pawinee Pangthipampai, M.D. Mahidol University

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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT02271646     History of Changes
Other Study ID Numbers: 070/2557(EC2)
(IO) R015731063 ( Other Grant/Funding Number: Faculty of medicine, Siriraj hospital, Mahidol university )
First Posted: October 22, 2014    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019

Keywords provided by Mahidol University:
paravertebral block
ultrasound guided

Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents