Clincosm LogoSign in Get a demo

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

Sponsor
Yonsei University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04773509
Collaborator
(none)
32
Enrollment
1
Location
2
Arms
19.3
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Paravertebral block
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Participant, Investigator, and outcomes assessor are blinded to group assignment.
Primary Purpose:
Treatment
Official Title:
Effect of Intraoperative Paravertebral Block on Postoperative Pain and Recovery in Patients Undergoing Mechanical Correction for Scoliosis
Actual Study Start Date :
Jun 24, 2021
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Pain score [6 hours after the end of surgery]

    visual analog scale (VAS) (0-10)

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients undergoing mechanical correction
Exclusion Criteria:

  • The subjects who cannot communicate

  • The subject is a foreigner or illiterate

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine Seoul Korea, Republic of

Sponsors and Collaborators

  • Yonsei University

Investigators

  • Principal Investigator: Bora Lee, Severance Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yonsei University
ClinicalTrials.gov Identifier:
NCT04773509
Other Study ID Numbers:
  • 4-2020-1467
First Posted:
Feb 26, 2021
Last Update Posted:
Jul 20, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Scoliosis
Pain, Postoperative

Study Results

No Results Posted as of Jul 20, 2021