Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04204720
Other study ID # 2018-06-007
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2018
Est. completion date December 15, 2019

Study information

Verified date December 2019
Source Kyungpook National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Caudal epidural injection (CEI) is effective for spinal pain. However, intravascular injection may occur during CEI, which can lead to hematoma, neurologic deficit and local anesthetics systemic toxicity. Whitacre type needle has been reported to be effective for reducing intravascular injection during transforaminal epidural injection. In this study, we compared the Chiba needle and Whitacre needle on incidence of intravascular injection during CEI.


Description:

A total of 164 caudal epidural injections were performed in patients with disc herniation or spinal stenosis on lumbosacral region. Patients were randomly allocated to Group Whitacre (n=82) and Group Chiba (n=82). Patients in Group Whitacre received caudal epidural injection using Whitacre type needle and those in Group Chiba received the procedure using Chiba type needle. Intravascular injection was assessed with blood aspiration and angiography during real-time fluoroscopy.


Recruitment information / eligibility

Status Completed
Enrollment 164
Est. completion date December 15, 2019
Est. primary completion date December 15, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- patients with low back pain and/or leg radicular pain under diagnoses as disc herniation or spinal stenosis

Exclusion Criteria:

- allergy to local anesthetics or contrast medium, coagulopathy, local infection at the injection site, and systemic infection

Study Design


Intervention

Device:
needle (Chiba)
intravascular injection using chiba needle during caudal epidural block
needle (Whitacre)
intravascular injection using whitacre needle during caudal epidural block

Locations

Country Name City State
Korea, Republic of Kyungpook National University Hospital Daegu

Sponsors (1)

Lead Sponsor Collaborator
Kyungpook National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary incidence of intravascular injection incidence of intravascular injection during caudal block 5 minute
See also
  Status Clinical Trial Phase
Recruiting NCT02555280 - Coflex PS3 Actual Conditions for Use Study N/A
Completed NCT05548608 - Lumbar Proprioception in Patients With Lumbar Spinal Stenosis
Completed NCT05619848 - Effect of Paravertebral Muscle Fat Infiltration on Rocuronium Use in Lumbar Surgery Early Phase 1
Recruiting NCT04401735 - Effects and Safety of Epidural PDRN vs. Placebo Phase 4
Recruiting NCT03105167 - Cortical Bone Trajectory Screws vs. Traditional Pedicle Screws Fixation N/A
Completed NCT03495661 - Decompression vs Physical Training for the Treatment of Lumbar Spinal Stenosis N/A
Not yet recruiting NCT06367855 - Efficacy and Safety of Preemptive Intravenous Dexamethasone in MIS-TLIF : Double Blinded, Randomized Control Trial Phase 4
Recruiting NCT05253326 - The Effect of Progressive Muscle Relaxation Exercises on Pain and Disability After Spinal Surgery N/A
Completed NCT04058171 - Validation of a Treadmill Walking Test to Discriminate Neurogenic Claudication From Vascular Claudication
Withdrawn NCT02982291 - Focused Spinal Stenosis Rehabilitation Program for Lumbar Spinal Stenosis N/A
Completed NCT03863769 - Chiropractic Distraction Spinal Manipulation- Lumbar Stenosis Study
Completed NCT03538093 - Lumbar Stabilization Exercises in Adult Patients With Lumbar Arthrodesis Surgery N/A
Not yet recruiting NCT04447950 - Randomized Control Trial of Quadratus Lumborum Block for Lumbar Spine Decompression and Fusion Surgery N/A
Completed NCT04443738 - Long Term Follow up of Spinal Stenosis Inpatients Treated With Korean Integrative Medicine Treatment.
Not yet recruiting NCT05297513 - Efficacy of ActiveMatrix on Spinal SSI Rate Phase 4
Active, not recruiting NCT04492774 - Degenerative Lumbar Stenosis Conservative Treatment Phase 4
Not yet recruiting NCT03584074 - Clinical Trial of Pregabalin and COX2 in Spinal Stenosis Phase 4
Completed NCT06393959 - Relief of Lumbar Spinal Stenosis Symptoms N/A
Completed NCT05161130 - Predicting Outcomes After Lumbar Fusion for Degenerative Disease
Completed NCT03884283 - Prospective, Multi-center Study to Assess Posterolateral Fusion Using FIBERGRAFT N/A