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

NCT04108507 | Completed

• 1 other identifier: SAHoWMU-CR2018-08-109
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporotic Fracture

Keywords

Percutaneous kyphoplasty（PKP）; nerve block; posterior branch of spinal nerve

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

posterior branch block of spinal nerve

EXPERIMENTAL

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

Procedure: posterior branch block of spinal nerve

without posterior branch block of spinal nerve

NO INTERVENTION

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

Interventions

posterior branch block of spinal nerve PROCEDURE

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

posterior branch block of spinal nerve

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• osteoporotic fracture
• acute vertebral compression fracture (within 2 weeks)
• fracture level lower thanT6

You may not qualify if:

• 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)

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

The 2nd Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, feykjkcy@163.com, China

Location

Related 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. 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.

  PMID: 20701962 RESULT

MeSH Terms

Conditions

Osteoporotic Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of Spinal surgery

Study Record Dates

• First Submitted: September 21, 2019
• First Posted: September 30, 2019
• Study Start: September 1, 2019
• Primary Completion: October 24, 2020
• Study Completion: October 24, 2020
• Last Updated: October 27, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)