Back to resultsEffect of Intraoperative Paravertebral Block on Postoperative Pain and Recovery in Patients Undergoing Mechanical Correction for Scoliosis
Primary Purpose
Scoliosis
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Paravertebral block
Sponsored by
About this trial
This is an interventional treatment trial for Scoliosis
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing mechanical correction
Exclusion Criteria:
- The subjects who cannot communicate
- The subject is a foreigner or illiterate
Sites / Locations
- Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
PVB group
Control group
Arm Description
Patients of the PVB group are performed PVB with 0.2% ropivacaine on both sides
PVB are not performed in the control group.
Outcomes
Primary Outcome Measures
Pain score
visual analog scale (VAS) (0-10)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04773509
Brief Title
Effect of Intraoperative Paravertebral Block on Postoperative Pain and Recovery in Patients Undergoing Mechanical Correction for Scoliosis
Official Title
Effect of Intraoperative Paravertebral Block on Postoperative Pain and Recovery in Patients Undergoing Mechanical Correction for Scoliosis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 24, 2021 (Actual)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
February 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Participant, Investigator, and outcomes assessor are blinded to group assignment.
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PVB group
Arm Type
Active Comparator
Arm Description
Patients of the PVB group are performed PVB with 0.2% ropivacaine on both sides
Arm Title
Control group
Arm Type
No Intervention
Arm Description
PVB are not performed in the control group.
Intervention Type
Procedure
Intervention Name(s)
Paravertebral block
Intervention Description
Randomly selected patients of the PVB group are performed PVB with 0.2% ropivacaine on both sides.
Primary Outcome Measure Information:
Title
Pain score
Description
visual analog scale (VAS) (0-10)
Time Frame
6 hours after the end of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing mechanical correction
Exclusion Criteria:
The subjects who cannot communicate
The subject is a foreigner or illiterate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bora Lee
Phone
82-2-2224-3919
Email
dreamkaist@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bora Lee
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bora Lee
Phone
82-2-2224-3919
Email
dreamkaist@yuhs.ac
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Intraoperative Paravertebral Block on Postoperative Pain and Recovery in Patients Undergoing Mechanical Correction for Scoliosis
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