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

NCT ID: NCT04773509

Last Updated: 2024-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-24

Study Completion Date

2023-12-24

Brief Summary

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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

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Conditions

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Scoliosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Participant, Investigator, and outcomes assessor are blinded to group assignment.

Study Groups

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PVB group

Patients of the PVB group are performed PVB with 0.2% ropivacaine on both sides

Group Type ACTIVE_COMPARATOR

Paravertebral block

Intervention Type PROCEDURE

Randomly selected patients of the PVB group are performed PVB with 0.2% ropivacaine on both sides.

Control group

PVB are not performed in the control group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Paravertebral block

Randomly selected patients of the PVB group are performed PVB with 0.2% ropivacaine on both sides.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing mechanical correction

Exclusion Criteria

* The subjects who cannot communicate
* The subject is a foreigner or illiterate
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bora Lee

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Locations

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Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2020-1467

Identifier Type: -

Identifier Source: org_study_id

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