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

NCT06315803 | Completed

• 1 other identifier: ChinaPLAGH20230601
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• the first success rate

  the incidence of success on the first puncture of the target

  during operation

• number of punctures

  number of punctures of the target

  during operation

• number of radiographies

  number of radiographies during punctures

  during operation

• puncture time

  how long hands are in contact with the needle

  during operation

Secondary Outcomes (4)

• operator confidence score

  Immediately after puncture

• operative time

  Immediately 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

• satisfaction of patients

  1 month after surgery

Other Outcomes (3)

• visual analog scale of pain

  The day before surgery and 1 month after surgery

• Oswestry disability index

  The day before surgery and 1 month after surgery

• modified Macnab criteria type

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

Study Arms (2)

Xplane ultrasound group

EXPERIMENTAL

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).

Device: Real-time 3D Xplane ultrasound

radiography group

NO INTERVENTION

The lumbar interforamen puncture was performed under the guidance of radiography with Mobile X-ray Image System (Arcadis Orbic 3D, Siemens, Germany) .

Interventions

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.

Xplane ultrasound group

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yi Mao: lead
• National Natural Science Foundation of China: collaborator

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

Related Publications (3)

• Li YY, Liu YH, Yan L, Xiao J, Li XY, Ma J, Jia LG, Chen R, Zhang C, Yang Z, Zhang MB, Luo YK. Single-plane versus real-time biplane approaches for ultrasound-guided central venous catheterization in critical care patients: a randomized controlled trial. Crit Care. 2023 Sep 23;27(1):366. doi: 10.1186/s13054-023-04635-y.

  PMID: 37742018 BACKGROUND

• GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1789-1858. doi: 10.1016/S0140-6736(18)32279-7. Epub 2018 Nov 8.

  PMID: 30496104 RESULT

• Zhang M, Yan L, Li S, Li Y, Huang P. Ultrasound-guided transforaminal percutaneous endoscopic lumbar discectomy: a new guidance method that reduces radiation doses. Eur Spine J. 2019 Nov;28(11):2543-2550. doi: 10.1007/s00586-019-05980-9. Epub 2019 May 13.

  PMID: 31087164 RESULT

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: There are practical differences in operation and blind methods cannot be achieved.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: clinician

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 18, 2024
• Study Start: June 23, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)