Effect of Intraoperative Paravertebral Block on Postopera... | NCT04773509

Studies
Effect of Intraoperative Paravertebral Block on Postoperative Pain and Recovery in Patients Undergoing Mechanical Correction for Scoliosis

NCT04773509

Sponsor

Yonsei University

Status

Completed

Last Update Posted

May 9, 2024Actual

Enrollment

32Actual

Phase

Not Applicable

Conditions

Scoliosis

Interventions

Paravertebral block

Countries

South Korea

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

Jul 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 24, 2021Actual

Primary Completion Date

Dec 24, 2023Actual

Completion Date

Dec 24, 2023Actual

First Submitted Date

Feb 24, 2021

First Submission Date that Met QC Criteria

Feb 24, 2021

First Posted Date

Feb 26, 2021Actual

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

May 7, 2024

Last Update Posted Date

May 9, 2024Actual

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

Pain management after scoliosis surgery is challenging for the anesthesiologists. This surgery causes severe postoperative pain and patients undergoing these operations are children or adolescents who are increased pain sensation compared with adults. Therefore, we aim to evaluate whether intraoperative paravertebral block (PVB) decreases postoperative pain in these patients. Thirty-two patients scheduled for mechanical correction due to scoliosis will be divided into PVB (n=16) and control (n=16) groups. Randomly selected patients of the PVB group are performed PVB with 0.2% ropivacaine on both sides. In contrast, PVB are not performed in the control group.

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

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PVB group	Active Comparator	Patients of the PVB group are performed PVB with 0.2% ropivacaine on both sides	Procedure: Paravertebral block
Control group	No Intervention	PVB are not performed in the control group.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Paravertebral block	Procedure	Randomly selected patients of the PVB group are performed PVB with 0.2% ropivacaine on both sides.	PVB group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain score	visual analog scale (VAS) (0-10)	6 hours after the end of surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing mechanical correction

Exclusion Criteria:

The subjects who cannot communicate
The subject is a foreigner or illiterate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bora Lee	Severance Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine		Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012600	Scoliosis

Ancestor Terms

ID	Term
D013121	Spinal Curvatures
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided