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

Primary Purpose

Osteoporotic Fracture

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
posterior branch block of spinal nerve
Sponsored by
Second Affiliated Hospital of Wenzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporotic Fracture focused on measuring Percutaneous kyphoplasty（PKP）, nerve block, posterior branch of spinal nerve

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • The 2nd Affiliated Hospital of Wenzhou Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

posterior branch block of spinal nerve

without posterior branch block of spinal nerve

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 21, 2019
Last Updated
October 24, 2020
Sponsor
Second Affiliated Hospital of Wenzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04108507
Brief Title
Prevention of Residual Low Back Pain After Percutaneous Kyphosis(PKP) Using Posterior Branch Block of Spinal Nerve
Official Title
Prevention of Residual Low Back Pain After Percutaneous Kyphosis(PKP) Using Posterior Branch Block of Spinal Nerve
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
October 24, 2020 (Actual)
Study Completion Date
October 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Second Affiliated Hospital of Wenzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporotic Fracture
Keywords
Percutaneous kyphoplasty（PKP）, nerve block, posterior branch of spinal nerve

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
198 (Actual)

8. Arms, Groups, and Interventions

Arm Title
posterior branch block of spinal nerve
Arm Type
Experimental
Arm Description
posterior branch block of spinal nerve during Percutaneous kyphoplasty(PKP)operation
Arm Title
without posterior branch block of spinal nerve
Arm Type
No Intervention
Arm Description
without posterior branch block of spinal nerve during Percutaneous kyphoplasty(PKP) operation
Intervention Type
Procedure
Intervention Name(s)
posterior branch block of spinal nerve
Intervention Description
posterior branch block of spinal nerve during Percutaneous kyphoplasty(PKP) operation
Primary Outcome Measure Information:
Title
Residual low back pain after operation
Description
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.
Time Frame
6 months after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
The 2nd Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
feykjkcy@163.com
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20701962
Citation
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. Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial. Lancet. 2010 Sep 25;376(9746):1085-92. doi: 10.1016/S0140-6736(10)60954-3. Epub 2010 Aug 9.
Results Reference
result

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

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