Success of Paravertebral Blocks in Analgesia for Interventional Hepatic Procedures

Liver Neoplasms Clinical Trial

Official title:

Randomised Double Blind Controlled Study of the Effectiveness of Paravertebral Nerve Block in Decreasing Analgesia Requirements and Improving Patient Experience During Interventional Hepatic Procedures.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01711450
• Other study ID #: 12-263-SDR
• Status: Withdrawn
• Phase: N/A
• First received: October 18, 2012
• Last updated: March 22, 2016
• Start date: December 2012
• Est. completion date: June 2013

Study information

• Verified date: March 2016
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

This study is aimed at assessing whether performing a paravertebral block (a type of regional pain relief) can reduce the pain and anxiety patients experience during radiological procedures on the liver.

Description:

Percutaneous procedures of the liver can be very painful and range from bliliary drain insertions to tumor ablation procedures. The study will randomize patients in two groups, one receiving a paravertebral nerve block prior to the procedure and one receiving a sham procedure in which saline will be injected in the paravertebral space. Pain scores and use of IV sedation will be monitored post procedure and both groups will be compared to assess whether paravetebral nerve blocks are effective at reducing pain in patients receiving such procedures.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

• Male or non-pregnant female subjects, between the ages of 18 and 80 at the time of enrollment.

Subjects referred for liver/biliary interventions to the angiography department.

Written informed consent to participate in the study. Ability to comply with the requirements of the study procedures

Exclusion Criteria:

• Subjects who participated in an active stage of any drug, intervention or treatment trial within 30 days of enrollment.

Subjects with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study. Patients will only be excluded on this basis following discussion with another interventional radiologist.

Subjects who are uncooperative or cannot follow instructions. Mental state that may preclude completion of the study procedure or ability to obtain informed consent.

Pregnant or nursing female subjects. Patient who are to undergo liver biopsy or routine biliary tube exchange. Patients with neurological/spinal conditions, or a BMI over 40, that would prevent safe/effective or well-targeted paravertebral blockade.

Patient unable to tolerate the paravertebral block procedure, for example due to inability to lie prone

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Neoplasms

Intervention

Procedure:
• Paravertebral block
Injection of local anaesthesia into paravertebral space to provide analgesia
• Control sham procedure
Injection of Normal saline into the paravertebral space

Locations

Country	Name	City	State
Canada	Montreal General Hospital	Montreal	Quebec
Canada	Royal Victoria Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Richard Lindsay

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose of intravenous sedation required during and after the procedure		1 hour	No
Secondary	Improvement in analogue pain scoring after the procedure		1 hour	No
Secondary	Procedure duration		1 hour	No
Secondary	Complication rate of liver procedure		24 hours	Yes
Secondary	Complication rate of paravertebral block		1 hour	Yes