Randomized Controlled Clinical Study to Validate the Clinical Accuracy and Safety of Biplanar Ultrasound-guided Puncture of Lumbar Interforamen in Adults
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Lumbar Disc Herniation
- Sponsor
- Yi Mao
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- number of radiographies
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Yi Mao
clinician
Chinese PLA General Hospital
Eligibility Criteria
Inclusion Criteria
- •16 to 80 years of age;
- •symptoms and confirmatory signs of lumbar radiculopathy that persisted for at least 6 weeks;
- •LDH at a corresponding level and side on imaging;
- •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
- •other diseases affecting the spine (tumor, infection, metabolic disease, immune system disease and fractures);
- •body mass index (BMI) greater than 32 kg/m2;
- •refusal to participate;
- •severe mental illnesses in the trial.
Outcomes
Primary Outcomes
number of radiographies
Time Frame: during operation
number of radiographies during punctures
puncture time
Time Frame: during operation
how long hands are in contact with the needle
number of punctures
Time Frame: during operation
number of punctures of the target
the first success rate
Time Frame: during operation
the incidence of success on the first puncture of the target
Secondary Outcomes
- operator confidence score(Immediately after puncture)
- operative time(Immediately after surgery)
- satisfaction of patients(1 month after surgery)
- incidence of puncture relevant complications(The patient was examined for neurovascular injury immediately after the puncture. Other complications were observed 1 month after surgery)