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

Sponsor

Second Affiliated Hospital of Wenzhou Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT04108507

Collaborator

(none)

198

Enrollment

Location

Arms

13.8

Actual Duration (Months)

14.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoporotic Fracture	Procedure: posterior branch block of spinal nerve	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

198 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2019

Actual Primary Completion Date :

Oct 24, 2020

Actual Study Completion Date :

Oct 24, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: posterior branch block of spinal nerve posterior branch block of spinal nerve during Percutaneous kyphoplasty(PKP)operation	Procedure: posterior branch block of spinal nerve posterior branch block of spinal nerve during Percutaneous kyphoplasty(PKP) operation
No Intervention: without posterior branch block of spinal nerve without posterior branch block of spinal nerve during Percutaneous kyphoplasty(PKP) operation

Arm

Intervention/Treatment

Experimental: posterior branch block of spinal nerve

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

Procedure: posterior branch block of spinal nerve

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

No Intervention: without posterior branch block of spinal nerve

without posterior branch block of spinal nerve during Percutaneous kyphoplasty(PKP) operation

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)