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

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.

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Key information

Conditions

Osteoporotic Fracture Fractures, Bone Osteoporotic Fractures Wounds and Injuries

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The 2nd Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, [email protected], China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

posterior branch block of spinal nerve

Procedure

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

Primary outcomes

Residual low back pain after operation

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Wenzhou Medical University

Other

Registry information

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Sep 30, 2019
Registry last updated: Oct 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed