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Success of Paravertebral Blocks in Analgesia for Interventional Hepatic Procedures

Primary Purpose

Liver Neoplasms

Status

Withdrawn

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Paravertebral block

Control sham procedure

About this trial

This is an interventional treatment trial for Liver Neoplasms

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Royal Victoria Hospital
Montreal General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Paravertebral block

Control sham procedure

Arm Description

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

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

Outcomes

Primary Outcome Measures

Dose of intravenous sedation required during and after the procedure

Secondary Outcome Measures

Improvement in analogue pain scoring after the procedure

Procedure duration

Complication rate of liver procedure

Complication rate of paravertebral block

Full Information

NCT ID

NCT01711450

First Posted

October 18, 2012

Last Updated

March 22, 2016

Sponsor

Richard Lindsay

1. Study Identification

Unique Protocol Identification Number

NCT01711450

Brief Title

Success of Paravertebral Blocks in Analgesia for Interventional Hepatic Procedures

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.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Withdrawn

Why Stopped

Institutional Ethics Board concern regarding sham procedure, requiring modifications that are not feasible within the man-power limitations of our institution.

Study Start Date

December 2012 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Richard Lindsay

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Neoplasms

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Paravertebral block

Arm Type

Experimental

Arm Description

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

Arm Title

Control sham procedure

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Paravertebral block

Intervention Description

Injection of local anaesthesia into paravertebral space to provide analgesia

Intervention Type

Procedure

Intervention Name(s)

Control sham procedure

Intervention Description

Injection of Normal saline into the paravertebral space

Primary Outcome Measure Information:

Title

Dose of intravenous sedation required during and after the procedure

Time Frame

1 hour

Secondary Outcome Measure Information:

Title

Improvement in analogue pain scoring after the procedure

Time Frame

1 hour

Title

Procedure duration

Time Frame

1 hour

Title

Complication rate of liver procedure

Time Frame

24 hours

Title

Complication rate of paravertebral block

Time Frame

1 hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

95 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard Lindsay, MB Bch

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Louis Boucher, MD

Organizational Affiliation

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

Official's Role

Study Director

Facility Information:

Facility Name

Royal Victoria Hospital

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3A 1A1

Country

Canada

Facility Name

Montreal General Hospital

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3G 1A4

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Success of Paravertebral Blocks in Analgesia for Interventional Hepatic Procedures

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