The Selective Intraperineural Nerve Root Block Study

Официальное название

Feasibility, Safety and Diagnostic Accuracy of Selective Intraperineural Nerve Root Block for Identifying Compressed Nerve Root in Lumbosacral Radicular Pain. A Prospective Cohort Study

Обзор

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

Подробное описание

\[Background\] It has been reported that approximately 85% of sciatica cases result from nerve root compression secondary to lumbar disc herniation or lumbar spinal stenosis, a clinical entity defined as radicular pain that manifests as radiating pain involving the buttocks and lower extremities. For patients with an inadequate response to conservative management, surgical decompression of the compressed nerve root serves as a conventional and highly effective therapeutic option. Furthermore, if the pain generator can be confirmed to arise from a single nerve root, targeted single-level decompression of that individual nerve root is generally sufficient for pain relief. However, limitations of conventional imaging examinations coupled with overlapping innervation territories of multiple lumbosacral nerve roots often make accurate identification of the symptomatic compressed nerve root challenging in certain patient populations. Misidentification of the pathological nerve root may consequently lead to surgical failure. To address this clinical dilemma, diagnostic selective nerve root block (SNRB) is regarded as the most valuable adjunct modality. In routine clinical practice, complete pain remission following SNRB indicates that the nerve root infiltrated by local anesthetics is the primary pain source.

Regrettably, prior relevant studies have demonstrated that conventional SNRB exhibits relatively low overall diagnostic accuracy, failing to achieve satisfactory sensitivity and specificity simultaneously. Uncontrolled diffusion of injectable agents is recognized as the predominant contributor to such poor diagnostic performance. Specifically, unintended anesthetic contamination of adjacent unaffected nerve roots may trigger false-positive outcomes, while insufficient delivery of local anesthetics to the targeted nerve root can result in false-negative findings. At present, no techniques or strategies for precisely regulating drug distribution during SNRB procedures have been reported in the existing literature.

Interestingly, during the nerve root fluorography in some patients in our team, when linear striation opacities are visualized within the nerve root, which indicates occurrence of intraperineural, the contrast medium typically diffuses only inside and around the targeted nerve root. This phenomenon can also be observed in the illustrative images from a previous study on therapeutic SNRB, yet it seems to have attracted little attention from researchers. Additionally, the findings of this study demonstrated that intraperineural injection occurred in approximately 30% of patients undergoing therapeutic SNRB with accidental intraperineural injection, and no cases of neurological injury were documented during follow-up. Therefore, it is reasonable to hypothesize that intraperineural injection is a safe, feasible approach that enables precise distribution of agents to the targeted nerve root.

Using the postoperative efficacy of single-segment single-nerve-root decompression as the gold standard for identifying the compressed nerve root, the present study aimed to investigate the diagnostic accuracy, safety, and technical feasibility of selective intraperineural nerve root block (SINRB) in patients with radicular pain. A double-blind approach was implemented, with participants and assessors masked to the nerve root status (responsible vs. non-responsible) during evaluations. Meanwhile, to improve the success rate of intraperineural injection, to the best of our knowledge, the present study is the first to adopt three-dimensional computed tomography multiplanar volume reconstruction (3D-CT MPVR) imaging to visualize the anatomical course of the nerve root within the intervertebral foramen.

\[Sample Size Estimation\] To ensure adequate statistical power for accurately evaluating the diagnostic accuracy of selective intraperineural nerve root block (SINRB) in identifying the responsible compressed nerve root (RCNR) in patients with radicular pain, sample size calculation was performed based on diagnostic test design principles, incorporating the following key parameters: (from preliminary pilot data) an expected sensitivity of 95%, specificity of 96%, 95% confidence level, ±5% margin of error, and a 10% allowance for potential missing data or patient dropout. Using the single-proportion estimation method, the required numbers of positive and negative events were calculated separately for sensitivity and specificity. The sample size required for sensitivity was 80 cases, and for specificity was 66 cases. Accordingly, we plan to enroll 66 patients with single-level lesions (anticipated to yield one positive and one negative result each) and 14 patients with multi-level lesions (anticipated to yield one positive result each). This sample size sufficiently meets the statistical power requirements for the primary study objective-evaluating the sensitivity and specificity of SINRB for RCNR identification-ensuring the scientific rigor, stability, and generalizability of the study findings.

Вмешательства

• Диагностический тест 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
• Процедура 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.

Первичные конечные точки

• The change from baseline in standing impairment [Срок оценки: Baseline, 5mins after SINRB, the second day after ambulation, and 1 month postoperatively]
• Change from baseline in walking impairment [Срок оценки: Baseline, 5mins after SINRB, the second day after ambulation, and 1 month postoperatively]
• Change from baseline in straight leg raising impairment [Срок оценки: Baseline, 5mins after SINRB, the second day after ambulation, and 1 month postoperatively]
• Subjective pain relief [Срок оценки: 5mins after SINRB, the second day after ambulation, and 1 month postoperatively]

Вторичные конечные точки (5)

• Result of SINRB [Срок оценки: 5mins after SINRB]
• Overall clinical assessment after lumbar spine surgery [Срок оценки: the second day after ambulation, and 1 month postoperatively]
• The occurrence of complications [Срок оценки: 24hs after SINRB]
• Changes in neurological function before and after SINRB [Срок оценки: 24hs after SINRB]
• Success rate of SINRB procedure [Срок оценки: immediately post-SINRB]

Критерии участия

Критерии включения

• Unilateral sciatica >1 month with activity/daily life impairment.
• Suspected L5/S1 root compression at L4-5/L5-S1 with unconfirmed pain correlation, including disc herniation (MSU 1-B/1-A/2-A), lateral recess/foraminal stenosis (Lee grade 2/3), atypical sciatica, or imaging-exam inconsistency.
• Candidates for single-segment, single-root lumbar decompression, electing surgery after informed consent.

Критерии исключения

• No significant pre-SINRB/surgery pain, or weakness/numbness as primary symptom.
• Unidentifiable responsible compressed nerve root (RCNR) per surgery.
• Suspected compression of the same nerve root at more than one segment.
• Pregnancy, active malignancy, or surgical contraindications.
• Inability to cooperate with assessment due to comorbidities or dysfunction.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Китай · 1 центр

• Xi'an Honghui Hospital (North Campus) — Сиань

Публикации

• Sala-Blanch X, Lopez AM, Pomes J, Valls-Sole J, Garcia AI, Hadzic A. No clinical or electrophysiologic evidence of nerve injury after intraneural injection during sciatic popliteal block. Anesthesiology. 2011 Sep;115(3):589-95. doi: 10.1097/ALN.0b013e3182276d10. PMID 21862889
• Beynon R, Elwenspoek MMC, Sheppard A, Higgins JN, Kolias AG, Laing RJ, Whiting P, Hollingworth W. The utility of diagnostic selective nerve root blocks in the management of patients with lumbar radiculopathy: a systematic review. BMJ Open. 2019 Apr 20;9(4):e025790. doi: 10.1136/bmjopen-2018-025790. PMID 31005925
• Pfirrmann CW, Oberholzer PA, Zanetti M, Boos N, Trudell DJ, Resnick D, Hodler J. Selective nerve root blocks for the treatment of sciatica: evaluation of injection site and effectiveness--a study with patients and cadavers. Radiology. 2001 Dec;221(3):704-11. doi: 10.1148/radiol.2213001635. PMID 11719666

Идентификаторы

NCT: NCT07531485 · 2025--KY-085-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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