Learning Curves, Lumbar Disc Herniation, Percutaneous Endoscopic Lumbar Discectomy, Three-dimension Ultrasound
Conditions
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.
Interventions
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.
Sponsors
National Natural Science Foundation of China
Yi Mao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Masking description
There are practical differences in operation and blind methods cannot be achieved.
Eligibility
Sex/Gender
ALL
Age
16 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of radiographies | during operation | number of radiographies during punctures |
| number of punctures | during operation | number of punctures of the target |
| puncture time | during operation | how long hands are in contact with the needle |
| the first success rate | during operation | the incidence of success on the first puncture of the target |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| operative time | Immediately after surgery | The time between the start of the surgery and the end of the surgery |
| operator confidence score | Immediately after puncture | operator confidence score |
| satisfaction of patients | 1 month after surgery | satisfaction of patients(1-5points) from the last follow-up |
Other
| Measure | Time frame | Description |
|---|---|---|
| visual analog scale of pain | The day before surgery and 1 month after surgery | pain scores (1-10) on the visual analog scale for waist and leg |
| modified Macnab criteria type | the last follow-up (at least 1 month after surgery) | modified Macnab criteria type (excellent,good,fair,poor) |
| Oswestry disability index | The day before surgery and 1 month after surgery | Oswestry disability index |
Countries
China
Outcome results
None listed