Success of Paravertebral Blocks in Analgesia for Interventional Hepatic Procedures

NCT01711450 | Withdrawn

• 1 other identifier: 12-263-SDR
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Liver Neoplasms

Outcome Measures

Primary Outcomes (1)

• Dose of intravenous sedation required during and after the procedure

  1 hour

Secondary Outcomes (4)

• Improvement in analogue pain scoring after the procedure

  1 hour

• Procedure duration

  1 hour

• Complication rate of liver procedure

  24 hours

• Complication rate of paravertebral block

  1 hour

Study Arms (2)

Paravertebral block

EXPERIMENTAL

Paravertebral space will be needled and an anesthetic agent will be injected.

Procedure: Paravertebral block

Control sham procedure

PLACEBO COMPARATOR

Paravertebral space will be needled, but only normal saline injected.

Procedure: Control sham procedure

Interventions

Paravertebral block PROCEDURE

Injection of local anaesthesia into paravertebral space to provide analgesia

Paravertebral block

Control sham procedure PROCEDURE

Injection of Normal saline into the paravertebral space

Control sham procedure

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Richard Lindsay: lead

Study Sites (2)

Royal Victoria Hospital

Montreal, Quebec, H3A 1A1, Canada

Location

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Richard Lindsay, MB Bch

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

• Louis Boucher, MD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 18, 2012
• First Posted: October 22, 2012
• Study Start: December 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: June 1, 2013
• Last Updated: March 23, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)