Efficacy of Erector Spinae Plane Block for Postoperative... | NCT03454191

Studies
Efficacy of Erector Spinae Plane Block for Postoperative Analgesia in Adult Patients Undergoing Thoracoscopy

NCT03454191

Sponsor

Eric Albrecht

Status

Terminated

Last Update Posted

Aug 22, 2024Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Pain, Postoperative

Interventions

Erector spinae plane block
No injection

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Recruitment stopped due to lack of research assistant

Expanded Access Info

Start Date

Feb 1, 2018Actual

Primary Completion Date

Oct 1, 2023Actual

Completion Date

Oct 1, 2023Actual

First Submitted Date

Feb 27, 2018

First Submission Date that Met QC Criteria

Feb 27, 2018

First Posted Date

Mar 5, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 20, 2024

Last Update Posted Date

Aug 22, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Eric Albrecht, Program director of regional anaesthesia, Centre Hospitalier Universitaire VaudoisSponsor-Investigator

Lead Sponsor

Eric AlbrechtOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The erector spinae plane block has been recently described as an effective analgesic postoperative pain treatment in case reports. It consists of injecting local anaesthetics below the erector spinae muscle, at the level of the transverse processes, in order to anaesthetize the thoracic roots coming out from the spinal cord. However, the analgesic efficacy has never been demonstrated in a randomized controlled trial. Therefore, the objective of this study is to investigate the analgesic benefit of this block on patients scheduled for thoracoscopy.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Erector spinae plane block	Experimental		Procedure: Erector spinae plane block
Placebo	Placebo Comparator		Procedure: No injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Erector spinae plane block	Procedure	Injection of local anaesthetics below the erector spinae muscle after induction of anaesthesia	Erector spinae plane block

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
IV morphine consumption	mg	24 postoperative hours

Secondary Outcomes

Measure	Description	Time Frame
IV morphine consumption	mg	2 postoperative hours
IV morphine consumption	mg	48 postoperative hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients scheduled for thoracoscopy
physical status I-III

Exclusion Criteria:

allergy to local anaesthetics
other contraindications to peripheral nerve blocks
patients suffering from chronic pain condition

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne		Lausanne	Canton of Vaud	1011	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided