Success of Paravertebral Blocks in Analgesia for Interventional Hepatic Procedures

NCT ID: NCT01711450

Last Updated: 2016-03-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2013-06-30

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.

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.

Conditions

Liver Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Paravertebral block

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

Group Type: EXPERIMENTAL

Paravertebral block

Intervention Type: PROCEDURE

Injection of local anaesthesia into paravertebral space to provide analgesia

Control sham procedure

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

Group Type: PLACEBO_COMPARATOR

Control sham procedure

Intervention Type: PROCEDURE

Injection of Normal saline into the paravertebral space

Interventions

Paravertebral block

Injection of local anaesthesia into paravertebral space to provide analgesia

Intervention Type: PROCEDURE

Control sham procedure

Injection of Normal saline into the paravertebral space

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Richard Lindsay

OTHER

Sponsor Role: lead

Responsible Party

Richard Lindsay

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Richard Lindsay, MB Bch

Role: PRINCIPAL_INVESTIGATOR

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

Louis Boucher, MD

Role: STUDY_DIRECTOR

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

Locations

Royal Victoria Hospital

Montreal, Quebec, Canada

Montreal General Hospital

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

12-263-SDR

Identifier Type: -

Identifier Source: org_study_id