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NCT Number: NCT06315803

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

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.

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Key information

Conditions

Lumbar Disc Herniation Bone Diseases Hernia Intervertebral Disc Displacement Learning Curves Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Percutaneous Endoscopic Lumbar Discectomy Spinal Diseases Three-dimension Ultrasound

Age range

16 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;
  • pregnancy;
  • refusal to participate;
  • severe mental illnesses in the trial.

Treatment and study plan

Real-time 3D Xplane ultrasound

Device

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.

Primary outcomes

  1. the first success rate

    Time frame: during operation

    the incidence of success on the first puncture of the target

  2. number of punctures

    Time frame: during operation

    number of punctures of the target

  3. number of radiographies

    Time frame: during operation

    number of radiographies during punctures

  4. puncture time

    Time frame: during operation

    how long hands are in contact with the needle

Secondary outcomes

  1. operator confidence score

    Time frame: Immediately after puncture

    operator confidence score

  2. operative time

    Time frame: Immediately after surgery

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

  3. incidence of puncture relevant complications

    Time frame: 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

  4. satisfaction of patients

    Time frame: 1 month after surgery

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

Other outcomes

  1. visual analog scale of pain

    Time frame: The day before surgery and 1 month after surgery

    pain scores (1-10) on the visual analog scale for waist and leg

  2. Oswestry disability index

    Time frame: The day before surgery and 1 month after surgery

    Oswestry disability index

  3. modified Macnab criteria type

    Time frame: the last follow-up (at least 1 month after surgery)

    modified Macnab criteria type (excellent,good,fair,poor)

Sponsors and collaborators

Lead sponsor

Yi Mao

Other

Collaborators

  • National Natural Science Foundation of China

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 18, 2024
Registry last updated
Mar 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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