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

May 7, 2024 updated by: Yonsei University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • 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

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine

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

Ages Eligible for Study

10 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients undergoing mechanical correction

Exclusion Criteria:

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

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PVB group
Patients of the PVB group are performed PVB with 0.2% ropivacaine on both sides
Procedure: Paravertebral block
Randomly selected patients of the PVB group are performed PVB with 0.2% ropivacaine on both sides.
No Intervention: Control group
PVB are not performed in the control group.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Bora Lee, Severance Hospital

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)

June 24, 2021

Primary Completion (Actual)

December 24, 2023

Study Completion (Actual)

December 24, 2023

Study Registration Dates

First Submitted

February 24, 2021

First Submitted That Met QC Criteria

February 24, 2021

First Posted (Actual)

February 26, 2021

Study Record Updates

Last Update Posted (Actual)

May 9, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2020-1467

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

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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