Ultrasound Guided Thoracic Paravertebral Block for Hepatic Tumors Ablation

NCT02271646 | Completed

• 2 other identifiers: 070/2557(EC2)(IO) R015731063
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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).

Conditions

Liver Cancer

Keywords

paravertebral block; ultrasound guided

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 24 hours

Secondary Outcomes (1)

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

  After performing TPVB at 5, 10, 20 and 30 minutes.

Study Arms (1)

0.5% marcaine 20ml

EXPERIMENTAL

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

Interventions

0.5% marcaine 20ml DRUG

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

0.5% marcaine 20ml

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Patients undergo percutaneous radiofrequency ablation for liver tumors
• ASA classification 1-3

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead
• Siriraj Hospital: collaborator

Study Sites (1)

Siriraj hospital

Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Liver Neoplasms

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Pawinee Pangthipampai, M.D.

  Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2014
• First Posted: October 22, 2014
• Study Start: August 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 12, 2019

Record last verified: 2019-03

Locations

TH (1)