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

Osteoporotic Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04108507
• Other study ID #: SAHoWMU-CR2018-08-109
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: October 24, 2020

Study information

• Verified date: October 2020
• Source: Second Affiliated Hospital of Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: October 24, 2020
• Est. primary completion date: October 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Back Pain
• Kyphosis
• Low Back Pain
• Osteoporotic Fracture
• Osteoporotic Fractures

Intervention

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

Locations

Country	Name	City	State
China	The 2nd Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Wenzhou Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

Klazen CA, Lohle PN, de Vries J, Jansen FH, Tielbeek AV, Blonk MC, Venmans A, van Rooij WJ, Schoemaker MC, Juttmann JR, Lo TH, Verhaar HJ, van der Graaf Y, van Everdingen KJ, Muller AF, Elgersma OE, Halkema DR, Fransen H, Janssens X, Buskens E, Mali WP. V — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Residual low back pain 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.	6 months after operation