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

Not Applicable

Completed

• Conditions: Learning Curves; Lumbar Disc Herniation; Percutaneous Endoscopic Lumbar Discectomy; Three-dimension Ultrasound
• Interventions: Device: Real-time 3D Xplane ultrasound

• Registration Number: NCT06315803
• Lead Sponsor: Yi Mao

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-23
• Primary Completion: 2024-02-01
• Study Completion: 2024-02-01
• Status Verified: 2024-03
• Study First Submitted: 2024-03-05
• Study First Submitted QC: 2024-03-11
• Last Update Submitted: 2024-03-11
• Study First Posted: 2024-03-18
• Last Update Posted: 2024-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xplane ultrasound group	Real-time 3D Xplane ultrasound	The lumbar interforamen puncture was performed under the guidance of Xplane ultrasound with a X6-1 volume transducer probe (frequency range 1-6MHz, center frequency 3.2MHz).

Primary Outcome Measures

Name	Time	Method
number of radiographies	during operation	number of radiographies during punctures
puncture time	during operation	how long hands are in contact with the needle
number of punctures	during operation	number of punctures of the target
the first success rate	during operation	the incidence of success on the first puncture of the target

Secondary Outcome Measures

Name	Time	Method
operator confidence score	Immediately after puncture	operator confidence score
operative time	Immediately after surgery	The time between the start of the surgery and the end of the surgery
satisfaction of patients	1 month after surgery	satisfaction of patients(1-5points) from the last follow-up
incidence of puncture relevant complications	The patient was examined for neurovascular injury immediately after the puncture. Other complications were observed 1 month after surgery	neurovascular injury, cauda equina syndrome, dural tear, injection, hematoma and organ injury

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China