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The analgesic effect of local Infiltrating anesthesia within vertebra during the percutaneous kyphoplasty

The analgesic effect of local Infiltrating anesthesia within vertebra during the percutaneous kyphoplasty

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023433
Enrollment
Unknown
Registered
2019-05-27
Start date
2019-07-01
Completion date
Unknown
Last updated
2020-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

osteoporostic vertebral compression fracture

Interventions

experimental group:intravertebral infiltration of 0.5% lidocaine before balloon dilation
control group:intervertebral infiltration of 0.9% normal saline before balloon dilation

Sponsors

Affiliated Hospital of Southwest Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
50 Years to 100 Years

Inclusion criteria

Inclusion criteria: (1) history of mild violent trauma, the course of the disease 21d; (2) thoracic and back pain with limited motion range, affecting daily life; (3) MRI showed high signal changes in T2 images of the injured vertebra; (4) bone mineral density showed T value -2.5; (5) patients and their families require surgical treatment.

Exclusion criteria

Exclusion criteria: (1) the patient has no obvious clinical symptoms; (2) osteoporotic blowout fracture with incomplete posterior vertebral wall and obvious space occupying in the vertebral canal; (3) vertebral compression fractures caused by primary or metastatic tumors, tuberculosis and pathology; (4) patients with manifestations of spinal cord or nerve root injury; (5) patients with severe medical diseases cannot bear the operation; (6) patients with coagulation dysfunction or other diseases.

Design outcomes

Primary

MeasureTime frame
preoperative VAS of back pain;VAS of back pain one minute after intralvertebral infiltration;VAS of back pain at the intraballon pressure at 100 PSI after intralvertebral infiltration;VAS of back pain at the intraballon pressure at 200 PSI after intravertebral infiltration;VAS of back pain at the intraballon pressure at the highest PSI after intravertebral infiltration;preoperative ODI;postoperative ODI;preoperative local kyphosis;postoperative kyphosis;

Countries

China

Contacts

Public ContactQing Wang

Department of Spine Surgery, Affiliated Hospital of Southwest Medical University

wqspine2004@163.com+86 13982473000

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026