Success of Paravertebral Blocks in Analgesia for Interventional Hepatic Procedures

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Liver Neoplasms
• Intervention / Treatment: Procedure: Paravertebral block; Procedure: Control sham procedure

Detailed 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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3A 1A1
      • Royal Victoria Hospital
    • Montreal, Quebec, Canada, H3G 1A4
      • Montreal General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Paravertebral block; Paravertebral space will be needled and an anesthetic agent will be injected.	Procedure: Paravertebral block; Injection of local anaesthesia into paravertebral space to provide analgesia
PLACEBO_COMPARATOR: Control sham procedure; Paravertebral space will be needled, but only normal saline injected.	Procedure: Control sham procedure; Injection of Normal saline into the paravertebral space

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Dose of intravenous sedation required during and after the procedure	1 hour

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Richard Lindsay
• Investigators: Principal Investigator: Richard Lindsay, MB Bch, McGill University Health Centre/Research Institute of the McGill University Health Centre; Study Director: Louis Boucher, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (ACTUAL): May 1, 2013
• Study Completion (ACTUAL): June 1, 2013

Study Registration Dates

• First Submitted: October 18, 2012
• First Submitted That Met QC Criteria: October 18, 2012
• First Posted (ESTIMATE): October 22, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): March 23, 2016
• Last Update Submitted That Met QC Criteria: March 22, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms
• Other Study ID Numbers: 12-263-SDR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO