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

NCT04773509 | Completed DMC

• 1 other identifier: 4-2020-1467
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Scoliosis

Outcome Measures

Primary Outcomes (1)

• Pain score

  visual analog scale (VAS) (0-10)

  6 hours after the end of surgery

Study Arms (2)

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

Paravertebral block PROCEDURE

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

PVB group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients undergoing mechanical correction

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, South Korea

Location

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Bora Lee

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participant, Investigator, and outcomes assessor are blinded to group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: February 24, 2021
• First Posted: February 26, 2021
• Study Start: June 24, 2021
• Primary Completion: December 24, 2023
• Study Completion: December 24, 2023
• Last Updated: May 9, 2024

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)