- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07445386
Transdiscal vs Paravertebral Neurolytic Splanchnic Nerve Block for Upper Abdominal Cancer Pain
Comparison of Transdiscal and Paravertebral Approaches for Neurolytic Splanchnic Nerve Block in the Treatment of Upper Abdominal Cancer Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gokhan Yildiz
- Phone Number: TR 5059272589
- Email: gkoyldz@gmail.com
Study Locations
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-
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Ankara, Turkey (Türkiye)
- Recruiting
- Ankara Etlik City Hospital
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Contact:
- Gokhan Yildiz
- Phone Number: TR 5059272589
- Email: gkoyldz@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Presence of local anatomical variations
- Localized or systemic infection involving the procedural site
- Pregnancy
- Coagulopathy
- Presence of unstable psychiatric disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: transdiscal splanchnic neurolysis group
Transdiscal splanchnic neurolysis for upper gastrointestinal malignancy pain
|
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.
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|
Active Comparator: paravertebral splanchnic neurolysis group
Paravertebral splanchnic neurolysis for upper gastrointestinal malignancy pain
|
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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numerical rating scale (NRS)
Time Frame: Change from baseline to post-treatment day 3, and at 1 and 3 months.
|
NRS is a scale that can be used measuring pain.
Scores range from 0 (no pain) to 10 (the worst pain)
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Change from baseline to post-treatment day 3, and at 1 and 3 months.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
EORTC QLQ-C30 questionnaire
Time Frame: Change from baseline to 1st and 3rd month after treatment
|
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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Change from baseline to 1st and 3rd month after treatment
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Fluoroscopy imaging time
Time Frame: During procedure
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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.
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During procedure
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gokhan Yildiz, Ankara Etlik City Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Endocrine System Diseases
- Neoplasms by Site
- Neoplasms
- Signs and Symptoms, Digestive
- Digestive System Neoplasms
- Digestive System Diseases
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Liver Diseases
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Cancer Pain
- Abdominal Pain
- Pancreatic Neoplasms
- Liver Neoplasms
Other Study ID Numbers
- Transdiscal vs Paravert SNB
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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