Ultrasound Guided Thoracic Paravertebral Block for Hepatic Tumors Ablation

Liver Cancer Clinical Trial

Official title:

Ultrasound Guided Thoracic Paravertebral Blocks: An Effective Pain Control in Percutaneous Radiofrequency Ablation of Hepatic Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02271646
• Other study ID #: 070/2557(EC2)
• Secondary ID: (IO) R015731063
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: March 2015

Study information

• Verified date: March 2019
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms

Intervention

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)

Locations

Country	Name	City	State
Thailand	Siriraj hospital	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Mahidol University	Siriraj Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain score at recovery room both at rest and movement (cough)	All patients at recovery room has mild pain (pain score	Up to 24 hours
Secondary	Distribution of local anesthetic drugs after performing ultrasound guided TPVB at T5-6, T7-8 and T9-10.	Test with cold sensation.	After performing TPVB at 5, 10, 20 and 30 minutes.