Prevention of Residual Low Back Pain After Percutaneous Kyphosis(PKP) Using Posterior Branch Block of Spinal Nerve

Not Applicable

Completed

• Conditions: Osteoporotic Fracture
• Interventions: Procedure: posterior branch block of spinal nerve

• Registration Number: NCT04108507
• Lead Sponsor: Second Affiliated Hospital of Wenzhou Medical University

Brief Summary

The purpose of this study was to block the posterior branch of lumbar spinal nerve during PKP operation and compare it with the patients without spinal nerve block, so as to verify the effect of posterior branch block of spinal nerve in relieving short-term and long-term residual low back pain after operation.

Detailed Description

Patients older than 60 years old who underwent Percutaneous kyphosis(PKP) surgery for osteoporotic fractures were randomly divided into two groups. The lumbar spinal nerve branch was blocked with betamethasone and ropivacaine in the experimental group during PKP operation, while the lumbar spinal nerve branch block was not performed in the control group during PKP operation. The low back pain was evaluated at 1 week, 2 weeks, 1 month, 3 months and 6 months after operation using Visual analogue pain score(VAS)scale.So as to compare the effect of lumbar spinal nerve block on residual pain after PKP.

Study Timeline

• Study Start: 2019-09-01
• Study First Submitted: 2019-09-21
• Study First Submitted QC: 2019-09-27
• Study First Posted: 2019-09-30
• Status Verified: 2020-10
• Primary Completion: 2020-10-24
• Study Completion: 2020-10-24
• Last Update Submitted: 2020-10-24
• Last Update Posted: 2020-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

Inclusion Criteria

• osteoporotic fracture
• acute vertebral compression fracture (within 2 weeks)
• fracture level lower thanT6

Exclusion Criteria

• other types of fractures
• patients younger than 60 years of age,
• with other disease (metabolic bone disease, metastasis, uncor- rectable coagulopathy, spinal infection, severe cardiopulmonary comorbidity, cognitive disorders etc)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
posterior branch block of spinal nerve	posterior branch block of spinal nerve	posterior branch block of spinal nerve during Percutaneous kyphoplasty(PKP)operation

Primary Outcome Measures

Name	Time	Method
Residual low back pain after operation	6 months after operation	Residual low back pain after operation using Visual analogue pain score(VAS) scale, VAS scores range from 0 to 10, more higher score means more severe pain, and residual back pain was defined as a VAS score greater than or equal to 4.

Trial Locations

Locations (1)

The 2nd Affiliated Hospital of Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China