Health TrialsbyHealthPanel

Transdiscal vs Paravertebral Neurolytic Splanchnic Nerve Block for Upper Abdominal Cancer Pain

ConditionCancer Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnkara Etlik City Hospital

About this trial

This study aims to compare the efficacy of fluoroscopy-guided paravertebral (PV) and transdiscal (TD) approaches for splanchnic nerve neurolysis in patients with upper abdominal cancer-related pain (e.g., gastric, pancreatic, and hepatic malignancies). Treatment response will be assessed using the Numerical Rating Scale (NRS), and the impact of both techniques on quality of life will be evaluated with the EORTC QLQ-C30 questionnaire.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Severe abdominal pain (NRS > 6) due to upper intra-abdominal organ malignancies (such as gastric, pancreatic, or hepatic cancer).

Failure of pain control with conservative treatment modalities.

Disqualifiers

Presence of local anatomical variations

Localized or systemic infection involving the procedural site

Pregnancy

Coagulopathy

Trial design

Design model

Parallel

Treatments tested in this trial

  • transdiscal splanchnic neurolysis

    Procedure/Surgery

    With the patient in the prone position, the T11-T12 vertebral levels were identified under anteroposterior fluoroscopic guidance, and the C-arm was adjusted to align the superior and inferior endplates of the T11-T12 intervertebral disc. The fluoroscope was then rotated obliquely to position the tip of the T12 superior articular process at the midpoint of the T11 vertebral body. After local anesthesia with 2 mL of 1% lidocaine, a spinal needle was advanced to the target point. The ideal final needle position was at the center of the intervertebral disc on the anteroposterior view and at the anterior border of the vertebral body on the lateral view. Correct needle placement was confirmed fluoroscopically, followed by injection of 1-2 mL of nonionic contrast to verify appropriate retrocrural spread. After a successful test dose with 10 mL of 1% lidocaine resulting in \>50% pain relief, 10 mL of 96% alcohol was slowly injected for neurolysis.

  • paravertebral splanchnic neurolysis

    Procedure/Surgery

    Under C-arm fluoroscopic guidance, the inferior border of the T11 vertebral body was used as a reference, and the fluoroscope was adjusted to a 15-20° craniocaudal and approximately 15-20° oblique angle. The needle entry point was selected slightly inferior to the T11 transverse process, and after local anesthesia with 2 mL of 1% lidocaine, the spinal needle was advanced along the lateral aspect of the vertebral body. On lateral fluoroscopic view, the needle tip was positioned at the anterior two-thirds of the vertebral body. Correct needle placement was confirmed fluoroscopically, followed by negative aspiration and injection of 1-2 mL of nonionic contrast to verify appropriate retrocrural spread. After a successful test dose with 5 mL of 1% lidocaine resulting in \>50% pain relief, 5 mL of 96% alcohol was slowly injected for neurolysis. The same procedure was repeated contralaterally, resulting in a total of 10 mL of 96% alcohol.

Treatment groups

56 Participants
are divided into 2 treatment groups
Group A: transdiscal splanchnic neurolysis groupActive comparator 1 intervention
Group B: paravertebral splanchnic neurolysis groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Numerical rating scale (NRS)

NRS is a scale that can be used measuring pain. Scores range from 0 (no pain) to 10 (the worst pain)

Time frame
Change from baseline to post-treatment day 3, and at 1 and 3 months.

Secondary outcomes

1

EORTC QLQ-C30 questionnaire

The EORTC QLQ-C30 questionnaire is used to assess health-related quality of life in patients with cancer. It consists of 30 items comprising five functional scales (physical, role, emotional, cognitive, and social functioning), three symptom scales (fatigue, pain, and nausea/vomiting), a global health status/quality of life scale, and several single-item symptom measures. Scores are linearly transformed to a 0-100 scale. Higher scores on functional and global health scales indicate better quality of life, whereas higher scores on symptom scales indicate greater symptom burden.

Time frame
Change from baseline to 1st and 3rd month after treatment
2

Fluoroscopy imaging time

Fluoroscopy imaging time is used as a secondary outcome to evaluate procedural exposure. It is defined as the total duration of active fluoroscopic imaging, measured in seconds, from the first fluoroscopic image acquisition to the final image obtained during the procedure.

Time frame
During procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ankara Etlik City Hospital

Lead sponsor

Source ClinicalTrials.gov
Apply now