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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.
Cancer-related pain (CRP) is a complex and challenging condition to manage. Pain may be somatic, visceral, or neuropathic in origin, and more than 50% of patients present with a mixed pain pattern at the time of diagnosis. In addition to medical therapies such as opioids and adjuvant analgesics, various interventional procedures are used in the management of CRP. Among these, neurolytic nerve and plexus blocks represent effective options for patients with pain refractory to conservative treatment. Chemical neurolysis, as a minimally invasive neurolytic plexus block technique, provides effective analgesia by targeting both sensory afferent fibers and sympathetic fibers innervating visceral organs. Identifying the most appropriate block according to pain localization plays a crucial role in achieving successful pain control.
Splanchnic nerve neurolysis is an established interventional technique for the management of upper abdominal cancer pain associated with pancreatic, gastric, and hepatic malignancies. Both the paravertebral (PV) and transdiscal (TD) approaches have been shown to effectively reduce cancer-related abdominal pain and significantly improve quality of life in affected patients. However, comparative data between these two techniques remain limited.
The primary aim of this study is to compare the efficacy of paravertebral (PV) and transdiscal (TD) splanchnic nerve neurolysis in patients with severe upper abdominal cancer pain refractory to medical therapy, using the Numerical Rating Scale (NRS) for pain assessment. Secondary aims include evaluating the impact of these techniques on quality of life using the EORTC QLQ-C30 questionnaire, comparing changes in opioid consumption, comparing procedure duration and fluoroscopy imaging time, and determining the incidence of adverse events.
A total of 56 patients, 28 in each group, will be enrolled. Pain intensity will be assessed using the NRS before the procedure and at 3 days, 1 month, and 3 months after the intervention. Quality of life will be evaluated using the EORTC QLQ-C30 questionnaire before the procedure and at 1 and 3 months post-intervention. Procedure-related adverse events will be recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| transdiscal splanchnic neurolysis group | Active Comparator | Transdiscal splanchnic neurolysis for upper gastrointestinal malignancy pain |
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| paravertebral splanchnic neurolysis group | Active Comparator | Paravertebral splanchnic neurolysis for upper gastrointestinal malignancy pain |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transdiscal splanchnic neurolysis | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Change from baseline to post-treatment day 3, and at 1 and 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gokhan Yildiz | Contact | 5059272589 | TR | gkoyldz@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Gokhan Yildiz | Ankara Etlik City Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Etlik City Hospital | Recruiting | Ankara | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D000072716 | Cancer Pain |
| D015746 | Abdominal Pain |
| D010190 | Pancreatic Neoplasms |
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| paravertebral splanchnic neurolysis | Procedure | 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. |
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| Change from baseline to 1st and 3rd month after treatment |
| 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. | During procedure |
| D012817 | Signs and Symptoms, Digestive |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D008107 | Liver Diseases |