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

Yi Mao76 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Lumbar Disc Herniation Percutaneous Endoscopic Lumbar Discectomy Three-dimension Ultrasound Learning Curves

Eligibility

Sex: ALLMin age: 16 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

the first success rate

the incidence of success on the first puncture of the target

Time frame: during operation

number of punctures

number of punctures of the target

Time frame: during operation

number of radiographies

number of radiographies during punctures

Time frame: during operation

puncture time

how long hands are in contact with the needle

Time frame: during operation

Secondary Outcomes

operator confidence score

Time frame: Immediately after puncture

operative time

The time between the start of the surgery and the end of the surgery

Time frame: Immediately after surgery

incidence of puncture relevant complications

neurovascular injury, cauda equina syndrome, dural tear, injection, hematoma and organ injury

Time frame: The patient was examined for neurovascular injury immediately after the puncture. Other complications were observed 1 month after surgery

satisfaction of patients

satisfaction of patients(1-5points) from the last follow-up

Time frame: 1 month after surgery

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes