Analgesic Efficacy of Single-shot Erector Spinae Block for Thoracic Surgery (AnESTh)

May 10, 2021 updated by: Jason Wilson, University of British Columbia
The erector spinae plane (ESP) block is a novel regional anesthetic technique for the treatment of thoracic, cervical, and abdominal pain. This pilot study aims to investigate the post-operative analgesic effectiveness of ultrasound guided single-shot ESP blocks for patients undergoing minimally invasive thoracoscopic wedge resections of the lung in comparison to those receiving conventional parental opioid analgesia alone. This will be achieved through the use of objective measures including quality the 40 point Quality of Recovery assessment (QoR-40) on postoperative day (POD) 1, visual-analogue pain scale (VAS) in the post-anesthetic care unit (PACU) and at POD 1, and oral morphine-equivalent (OME) opioid consumption in the PACU and at 24 hours post-operatively.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Purpose To investigate the postoperative analgesic effectiveness of the ultrasound-guided ESP block compared to a placebo injection for patients undergoing thoracoscopic wedge resection of the lung.

Hypothesis Thoracoscopic surgery patients who receive an ESP block in addition to current standard of care, consisting of parenteral and enteral opioids and surgical wound infiltration, will have a clinically significant improvement in their QoR-40 at POD 1 and lower pain levels, as measured by VAS in the PACU on arrival and one hour after, and on POD 1, and OME opioid consumption in the PACU and at 24 hours post-operatively, in comparison to those patients who receive the current standard of care along with a placebo injection.

Justification The ESP block is a novel regional anesthetic technique that has shown efficacy in the management of thoracic pain as published in numerous case reports and observational case series. To date, no randomized control trials exist of its efficacy in comparison to conventional parental opioid analgesic management. Thoracoscopic wedge resections of the lung are procedures not usually treated with regional analgesia techniques, but given the moderate pain experienced by many patients, this surgical population will serve as a proof-of-concept for the potential of improved post-operative analgesic and recovery profiles. Proof of analgesic efficacy in this setting may allow a future head-to-head comparison with more invasive analgesic techniques currently used for thoracic surgery such as epidural and paravertebral catheterizations.

In undertaking this aim, we will measure a number of different metrics. The 40-item Quality of Recovery Score (QoR-40) will be our primary objective as it provides a patient-centered global measure of overall health in the postoperative period. It has been tested for validity and reliability, and has undergone quantification for the minimal clinically important difference. Other traditional metrics of analgesic performance including the VAS and 24-hour post-op OME opioid consumption will also be monitored as secondary objectives.

Objectives

Primary Objective:

• Quality-of-Recovery 40 scale at POD 1.

Secondary Objectives:

  • Cumulative OME opioid consumption intra-operatively and through PACU, and at 24 hours post operatively.
  • Visual analog pain scale assessments post-operatively in PACU on arrival, after 1 hour, and at POD 1.

Research Design The study will be a prospective, single center, randomized, placebo-controlled pilot study requiring 2 patient visits for assessment in the PACU and on POD 1. One interim analysis for safety monitoring will be undertaken.

Sample Size Calculation and Statistical Methods No prior studies have been conducted to calculate an exact sample size calculation. Based on similar work, we will power this study on an expected difference of at least 10 points on the QoR-40 and a SD of 15 when comparing the block to placebo. This is a clinically meaningful difference. Assuming an alpha level of 0.05 and a power of 0.80, our sample size is 74. With a 10% dropout rate we will require recruitment of 82 patients. All outcomes will be analysed with the independent student t-test.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1L8
        • UBC/Medicine, Faculty of/Anesthesiology, Pharmacology & Therapeutics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-75 years of age
  • Presenting for elective thoracoscopic wedge resection
  • Proficient in the use of the English language
  • Able to provide informed consent
  • Expected stay > 24 hrs in hospital

Exclusion Criteria:

  • ASA greater than, or equal to 4
  • Expected post-operative endotracheal intubation
  • High likelihood of conversion to open thoracotomy
  • A diagnosis of a chronic pain condition
  • Depression or other psychiatric diagnosis
  • Dementia
  • Pregnancy
  • Preoperative opioid use >30mg of oral morphine equivalents per day
  • Known alcohol or recreational drug abuse
  • Contraindication to local anesthetic use including allergy or sensitivity to ropivacaine or other amide-type local anesthetics
  • Contraindication to the ESP block or regional anesthetic technique including: allergy or sensitivity to ultrasound gel; previous spine instrumentation; previous rib surgery; injured, diseased, or infected skin overlying the area to be blocked
  • Perioperative use, or planned use, of alternative regional anesthetic technique (not including surgical local anesthetic infiltration)
  • Perioperative ketamine and lidocaine infusion use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment
Patients in the experimental arm will receive an ESP block prior to induction of general anesthetic for their thoracoscopic wedge resection
Procedure: ESP block
An ESP block will be performed prior to surgery for postoperative pain control
Placebo Comparator: Placebo
Patients allocated to the placebo-control arm will receive a placebo injection of normal saline in a fashion almost identical to that of the ESP block.
Procedure: Placebo
A sham ESP block will be performed before surgery in the placebo group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Quality-of-Recovery 40 (QoR-40) scale at POD 1.
Time Frame: Postoperative day 1. Will be completed on the ward 24hrs after surgery
The QoR-40 is a widely used and extensively validated measure of quality of recovery
Postoperative day 1. Will be completed on the ward 24hrs after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Morphine usage
Time Frame: 30 minutes post-operatively in the PACU and 24hr after surgery.
Cumulative morphine-equivalent opioid consumption intra-operatively, in PACU (post-anesthetic care unit) and at 24 hours.
30 minutes post-operatively in the PACU and 24hr after surgery.
Visual analog pain scale (VAS) assessments post-operatively in PACU, and at POD 1.
Time Frame: 30 minutes post-operatively in the PACU and 24hrs after surgery
Patients will rate their pain on a scale from 0-10 as per standard VAS pain scoring systems.
30 minutes post-operatively in the PACU and 24hrs after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of British Columbia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jason M Wilson, MD PhD, University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 3, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 12, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 1, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H18-00029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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