Erector Spinae Block in First Rib Resection: a Monocentri... | NCT04167046

Studies
Erector Spinae Block in First Rib Resection: a Monocentric Before-after Study

NCT04167046

Sponsor

University Hospital, Angers

Status

Unknown status

Last Update Posted

Nov 18, 2019Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Thoracic Surgery

Interventions

Erector spinae block

Countries

France

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

Nov 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2019Estimated

Primary Completion Date

Mar 2021Estimated

Completion Date

Mar 2021Estimated

First Submitted Date

Nov 14, 2019

First Submission Date that Met QC Criteria

Nov 14, 2019

First Posted Date

Nov 18, 2019Actual

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

Nov 14, 2019

Last Update Posted Date

Nov 18, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

First rib resection surgery for thoracic outlet syndrome is associated with an intense postoperative pain. It leads to significant consumption of nonsteroidal anti-inflammatory drugs and opioids, and hospitalization for several days.

In our center, first rib resection surgery was usually performed under general anesthesia combined with diffuse local infiltration of the axillary fossa. Erector spinae block is an interfascial block where a local anesthetic is injected between the erector spinae muscle and the transverse process, in order to obtain a multimetameric analgesia. It has now shown its efficacy and its safety in thoracic and abdominal surgeries by decreasing the morphine consumption and pain scores. Since November 2018, this erector spinae block is systematically performed preoperatively for first rib resection in our center, in association with a general anesthesia. Patient satisfaction seems important but remains to be assessed objectively.

In a before-after study, our goal is to assess the impact of the use of erector spinae block on postoperative pain in the first rib resection surgery.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control		Patients in this group did not receive an erector spinae block. Data are obtained retrospectively (years 2017 and 2018).
Erector spinae block		Patients in this group receive an erector spinae block. Data will be obtained prospectively.	Procedure: Erector spinae block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Erector spinae block	Procedure	Preoperative erector spinae block.	Erector spinae block

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain assessment at H+48	Numerical pain rating scale: 0 (no pain at all) to 10 (worst imaginable pain)	Day 2 after surgery

Secondary Outcomes

Measure	Description	Time Frame
Postoperative pain assessment at other times	Numerical pain rating scale: 0 (no pain at all) to 10 (worst imaginable pain)	Hour 2, Day 1, and Day 3 after surgery
Total consumption of morphine (per and postoperative)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

First rib resection for thoracic outlet syndrome

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

Patients undergoing first rib resection for thoracic outlet syndrome

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Emmanuel Rineau, MD	Contact	+33241353951		erineau@live.fr
Siaudeau Hélène, MD	Contact	+33241353951

Overall Officials

Name	Affiliation	Role
Emmanuel Rineau, MD	University Hospital of Angers, France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Département d'Anesthésie-Réanimation du CHU d'Angers		Angers		49100	France