The Selective Intraperineural Nerve Root Block Study

NCT07531485 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-04-15

No results posted yet for this study

Summary

Before lumbosacral decompression surgery for radicular pain, selective nerve root block(SNRB) is a common procedure to identify the responsible compressed nerve root(RCNR) and predict surgical outcomes. However, the diagnostic accuracy of conventional SNRB is unsatisfactory, especially in terms of specificity. The main limitation is the uncontrolled distribution of anesthetics during injection: when anesthetics spread to surrounding soft tissues instead of acting directly on the RCNR, false-negative results may occur with persistent radicular pain; when anesthetics diffuse to two or more nerve roots including the RCNR, false-positive results may occur even if a normal nerve root is punctured, leading to misdiagnosis.

This study aims to evaluate the diagnostic accuracy of a novel three-dimensional computed tomography multiplanar volume reconstruction (3D-CT MPVR) guided selective intraperineural nerve root block(SINRB) for identifying the RCNR in patients with lumbosacral radicular pain. The investigators hypothesize that this technique will achieve higher diagnostic specificity and overall accuracy than conventional SNRB, by ensuring anesthetics are delivered directly to the target nerve root. This improvement will help clinicians make more accurate surgical plans, achieve better targeted decompression, and ultimately improve postoperative pain relief and functional recovery for patients.

The main research questions to be addressed in this study are:

* What is the procedural success rate of SINRB?
* Whether SINRB may cause clinically detectable nerve injury?
* Whether sciatica is relieved after SINRB when only the responsible compressed nerve root is blocked?
* Whether sciatica is relieved after SINRB when only a normal unaffected nerve root is blocked?

Participants will:

* Undergo one or two SINRB procedures and a single-level lumbar decompression surgery
* Get assessment of pain, mobility disorder and neurological function

Conditions

  • Radiculopathy Lumbar
  • Radiculopathy Sacral
  • Radiculopathy Multiple Sites
  • Herniated Disc
  • Foraminal Stenosis

Interventions

DIAGNOSTIC_TEST

Selective Intraperineural Nerve Root Block(SINRB)

The patient was placed in a standard prone position. The cutaneous puncture point was confirmed via large C-arm oblique fluoroscopy with the projection angle strictly consistent with the preoperative protocol.All puncture manipulations were completed by an experienced spinal surgeon. Under intermittent fluoroscopic guidance, the puncture trajectory was adjusted to keep the needle parallel to the fluoroscopic beam, followed by slow needle advancement until radiating pain was evoked in the patient. The needle was further advanced approximately 1 mm, and 0.2 mL contrast medium was injected subsequently. The visualization of a linear streak shadow within the nerve root confirmed intraneural positioning. The needle was fixed in situ, and 0.5 mL lidocaine was injected.

PROCEDURE

single-level lumbar decompression surgery

All patients underwent single-level lumbar surgery with either endoscopic or conventional open single nerve root decompression, and postoperative anteroposterior and lateral lumbar radiographs were routinely obtained for imaging evaluation.

Sponsors & Collaborators

  • Xi'an Honghui Hospital

    lead OTHER

Principal Investigators

  • Lingjiang Li, Attending physician · Xi'an Honghui Hospital, Xi'an, Shaanxi Province, China

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-13
Primary Completion
2026-12-01
Completion
2027-01-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07531485 on ClinicalTrials.gov