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Ultrasound Guided Thoracic Paravertebral Block for Hepatic Tumors Ablation

Primary Purpose

Liver Cancer

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
0.5% marcaine 20ml
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Liver Cancer focused on measuring paravertebral block, ultrasound guided

Eligibility Criteria

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

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

Sites / Locations

  • Siriraj hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

0.5% marcaine 20ml

Arm Description

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

Outcomes

Primary Outcome Measures

pain score at recovery room both at rest and movement (cough)
All patients at recovery room has mild pain (pain score </= 3) and do not need any rescue analgesic drugs.

Secondary Outcome Measures

Distribution of local anesthetic drugs after performing ultrasound guided TPVB at T5-6, T7-8 and T9-10.
Test with cold sensation.

Full Information

First Posted
September 3, 2014
Last Updated
March 10, 2019
Sponsor
Mahidol University
Collaborators
Siriraj Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02271646
Brief Title
Ultrasound Guided Thoracic Paravertebral Block for Hepatic Tumors Ablation
Official Title
Ultrasound Guided Thoracic Paravertebral Blocks: An Effective Pain Control in Percutaneous Radiofrequency Ablation of Hepatic Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
Collaborators
Siriraj Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
Keywords
paravertebral block, ultrasound guided

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.5% marcaine 20ml
Arm Type
Experimental
Arm Description
3 levels ultrasound guided thoracic paravertebral blocks at T5-6, T7-8 and T9-10 (total 0.5% marcaine 20ml)
Intervention Type
Drug
Intervention Name(s)
0.5% marcaine 20ml
Intervention Description
3 levels ultrasound guided thoracic paravertebral block at T5-6, T7-8 and T9-10 (total 0.5% marcaine 20ml)
Primary Outcome Measure Information:
Title
pain score at recovery room both at rest and movement (cough)
Description
All patients at recovery room has mild pain (pain score </= 3) and do not need any rescue analgesic drugs.
Time Frame
Up to 24 hours
Secondary Outcome Measure Information:
Title
Distribution of local anesthetic drugs after performing ultrasound guided TPVB at T5-6, T7-8 and T9-10.
Description
Test with cold sensation.
Time Frame
After performing TPVB at 5, 10, 20 and 30 minutes.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pawinee Pangthipampai, M.D.
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Siriraj hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

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Ultrasound Guided Thoracic Paravertebral Block for Hepatic Tumors Ablation

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