Randomized Controlled Clinical Study of Biplanar Ultrasound-guided Puncture of Lumbar Interforamen

Lumbar Disc Herniation Clinical Trial

Official title:

Randomized Controlled Clinical Study to Validate the Clinical Accuracy and Safety of Biplanar Ultrasound-guided Puncture of Lumbar Interforamen in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06315803
• Other study ID #: ChinaPLAGH20230601
• Status: Completed
• Phase: N/A
• Start date: June 23, 2023
• Est. completion date: February 1, 2024

Study information

• Verified date: March 2024
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare Xplane ultrasound with radiography for guidance of lumbar interforamen puncture in patients with lumbar disc herniation. The main question[s] it aims to answer are:

• The feasibility that the Xplane ultrasound assists surgeon in mastering lumbar interforamen puncture faster than radiography.

• The clinical accuracy and safety of the Xplane ultrasound-guidance lumbar interforamen puncture faster.

Participants will undergo lumbar interforamen puncture with guidance of Xplane ultrasound or radiography. If there is a comparison group: Researchers will compare the first success rate, number of punctures, number of radiographies, puncture time and operator confidence score.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 80 Years

Eligibility

Inclusion Criteria:

1. 16 to 80 years of age;

2. symptoms and confirmatory signs of lumbar radiculopathy that persisted for at least 6 weeks;

3. LDH at a corresponding level and side on imaging;

4. surgical candidates for epidural steroid injection (ESI) or percutaneous endoscopic lumbar discectomy (PELD). If the patient underwent ESI and PELD surgery on the same day, we only selected the data for the first one.

Exclusion Criteria:

1. other diseases affecting the spine (tumor, infection, metabolic disease, immune system disease and fractures);

2. body mass index (BMI) greater than 32 kg/m2;

3. pregnancy;

4. refusal to participate;

5. severe mental illnesses in the trial.

Related Conditions & MeSH terms

• Intervertebral Disc Displacement
• Lumbar Disc Herniation

Intervention

Device:
• Real-time 3D Xplane ultrasound
After the puncture needle is in the skin, the longitudinal section of the Xplane mode can be adjusted to keep the needle in the proposed plane.

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Yi Mao	National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

References & Publications (3)

GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for — View Citation

Li YY, Liu YH, Yan L, Xiao J, Li XY, Ma J, Jia LG, Chen R, Zhang C, Yang Z, Zhang MB, Luo YK. Single-plane versus real-time biplane approaches for ultrasound-guided central venous catheterization in critical care patients: a randomized controlled trial. Crit Care. 2023 Sep 23;27(1):366. doi: 10.1186/s13054-023-04635-y. — View Citation

Zhang M, Yan L, Li S, Li Y, Huang P. Ultrasound-guided transforaminal percutaneous endoscopic lumbar discectomy: a new guidance method that reduces radiation doses. Eur Spine J. 2019 Nov;28(11):2543-2550. doi: 10.1007/s00586-019-05980-9. Epub 2019 May 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	visual analog scale of pain	pain scores (1-10) on the visual analog scale for waist and leg	The day before surgery and 1 month after surgery
Other	Oswestry disability index	Oswestry disability index	The day before surgery and 1 month after surgery
Other	modified Macnab criteria type	modified Macnab criteria type (excellent,good,fair,poor)	the last follow-up (at least 1 month after surgery)
Primary	the first success rate	the incidence of success on the first puncture of the target	during operation
Primary	number of punctures	number of punctures of the target	during operation
Primary	number of radiographies	number of radiographies during punctures	during operation
Primary	puncture time	how long hands are in contact with the needle	during operation
Secondary	operator confidence score	operator confidence score	Immediately after puncture
Secondary	operative time	The time between the start of the surgery and the end of the surgery	Immediately after surgery
Secondary	incidence of puncture relevant complications	neurovascular injury, cauda equina syndrome, dural tear, injection, hematoma and organ injury	The patient was examined for neurovascular injury immediately after the puncture. Other complications were observed 1 month after surgery
Secondary	satisfaction of patients	satisfaction of patients(1-5points) from the last follow-up	1 month after surgery