Neurolytic Block Techniques In Abdominal Visceral Cancer Pain

NCT06978673 | Not Yet Recruiting

• 1 other identifier: NP 076-210
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The neurolytic blocks of sympathetic chains are commonly used for the treatment of cancer-related pain. This study aims to compare celiac plexus neurolysis and splanchnic nerve neurolysis for the treatment of abdominal visceral pain and its influence on the quality of life of patients with cancer.

Conditions

Cancer, Malignant Tumors; Abdominal Cancer; Cancer Pain; Visceral Pain; Cancer-related Pain; Pain Management; Celiac Ganglia; Sympathetic Ganglia

Keywords

cancer pain; visceral pain; abdominal cancer; cancer; abdominal pain; cancer-related pain; pain management; neurolytic block; splanchnic nerve block; celiac plexus block; sympathetic neurolysis

Outcome Measures

Primary Outcomes (1)

• PAIN SCORE

  Pain will be assessed using the Numerical Rating Scale (NRS), a scale from 0 to 10 where: 0 indicates no pain and 10 indicates the worst possible pain. Scores are typically categorized as: Mild pain: 0-3 Moderate pain: 4-6 Severe pain: 7-10 Additionally, the Descriptive Verbal Scale will be used, with the following categories: No pain Mild pain Moderate pain Severe pain.

  1st Day Post-procedure; 15th Day Post-procedure; 30th Day Post-procedure; 2nd Month Post-procedure

Secondary Outcomes (2)

• Quality of life assessment.

  1st Day Post-procedure; 15th Day Post-procedure; 30th Day Post-procedure; 2nd Month Post-procedure

• Adverse Events

  1st Day Post-procedure; 15th Day Post-procedure; 30th Day Post-procedure; 2nd Month Post-procedure

Study Arms (2)

CELIAC PLEXUS NEUROLYSIS

ACTIVE COMPARATOR

The patient, under sedation and breathing spontaneously with oxygen support, will be placed in the horizontal prone position. Fluoroscopy will be used to locate the first lumbar vertebra, which will serve as a reference for the puncture site. Two 22G × 15 cm needles will be introduced bilaterally, up to 6 cm from the midline at the level of L1, and directed superiorly toward the transverse process of L1 under coaxial vision. Once they reach the vertebral body bilaterally, the needles will be positioned anterior to the vertebral body of L1, in the retroperitoneal region. The needle stylet will be removed, and the absence of blood, cerebrospinal fluid, or urine returning through the needle will be verified. If none of these signs are present, 2 ml of non-ionic contrast will be administered through the needle to confirm proper positioning in the retroperitoneum. After confirmation, 5 ml of absolute alcohol will be injected bilaterally.

Procedure: Celiac Plexus Neurolysis - 5 ml of absolute alcohol (100%)

SPLANCHNIC NERVE NEUROLYSIS

EXPERIMENTAL

The patient, under spontaneous breathing with oxygen support, will be placed in the horizontal prone position and supported by cushions placed under the iliac crests and chest. With a mark maintained over T11, the fluoroscopy machine will be positioned obliquely (approximately 45º), and the movement of the diaphragm-as well as its relationship with the vertebral body-will be observed during inspiration and expiration. The entry point will be at the junction of the rib and the vertebral body. The needle will be introduced using coaxial visualization to reach the lateral aspect of the vertebral body, near the costovertebral angle. With the fluoroscopy in profile, the needle will be advanced to the anterior third of the vertebral body, and any return of blood or cerebrospinal fluid will be checked. Non-ionic contrast will then be injected to confirm the needle position in both anteroposterior and lateral views. Finally, 5 ml of absolute alcohol will be injected through each needle.

Procedure: Splanchnic nerve neurolysis - 5 ml of absolute alcohol (100%)

Interventions

Splanchnic nerve neurolysis - 5 ml of absolute alcohol (100%) PROCEDURE

Splanchnic neurolysis will be performed with 5 ml of absolute alcohol on each side at the level of the eleventh thoracic vertebra.

Also known as: SPLANCHNIC NERVE BLOCK, SPLANCHNIC NERVE BLOCKADE, SPLANCHNIC BLOCK

SPLANCHNIC NERVE NEUROLYSIS

Celiac Plexus Neurolysis - 5 ml of absolute alcohol (100%) PROCEDURE

Celiac plexus neurolysis will be performed with 5 ml of absolute alcohol on each side at the level of the first lumbar vertebra.

Also known as: Celiac plexus block

CELIAC PLEXUS NEUROLYSIS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 years or older Presence of localized visceral pain in the upper abdomen originating from cancer of the stomach, duodenum, distal esophagus, ascending or transverse colon, liver, biliary tract, or pancreas
• Ineffectiveness of analgesic treatment with third-step opioids according to the WHO analgesic ladder, including:
• Opioids (≥ 60 mg/day of morphine equivalents) Antidepressants (tricyclic or dual-action), at any dosage Gabapentinoids, at any dosage Presence of side effects from analgesics that are difficult to manage with medication

You may not qualify if:

• Presence of ascites Presence of deep vein thrombosis Presence of hepatic failure: Child-Pugh class B or C Presence of renal failure: estimated glomerular filtration rate (eGFR) \< 60 ml/min/1.73 m² Use of any anticoagulant medication
• Clinical coagulation disorder, defined as:
• INR \> 1.5 Prothrombin activity \< 70% or prothrombin time \> 13.5 seconds aPTT \> 40 seconds Cardiovascular failure: NYHA class III

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead

Study Sites (1)

Instituto de Cancer Do Estado

São Paulo, São Paulo, 01246-000, Brazil

Location

Related Publications (9)

• Koyyalagunta D, Engle MP, Yu J, Feng L, Novy DM. The Effectiveness of Alcohol Versus Phenol Based Splanchnic Nerve Neurolysis for the Treatment of Intra-Abdominal Cancer Pain. Pain Physician. 2016 May;19(4):281-92.

  PMID: 27228515 BACKGROUND

• Ahmed A, Arora D. Fluoroscopy-guided Neurolytic Splanchnic Nerve Block for Intractable Pain from Upper Abdominal Malignancies in Patients with Distorted Celiac Axis Anatomy: An Effective Alternative to Celiac Plexus Neurolysis - A Retrospective Study. Indian J Palliat Care. 2017 Jul-Sep;23(3):274-281. doi: 10.4103/IJPC.IJPC_28_17.

  PMID: 28827930 BACKGROUND

• Uehara Y, Matsumoto Y, Kosugi T, Sone M, Nakamura N, Mizushima A, Miyashita M, Morita T, Yamaguchi T, Satomi E. Availability of and factors related to interventional procedures for refractory pain in patients with cancer: a nationwide survey. BMC Palliat Care. 2022 Sep 26;21(1):166. doi: 10.1186/s12904-022-01056-6.

  PMID: 36154936 BACKGROUND

• Hochberg U, Ingelmo P, Sole E, Miro J, Rivera G, Perez J. Early Interventional Treatments for Patients with Cancer Pain: A Narrative Review. J Pain Res. 2023 May 18;16:1663-1671. doi: 10.2147/JPR.S405808. eCollection 2023.

  PMID: 37223437 BACKGROUND

• Noble M, Gress FG. Techniques and results of neurolysis for chronic pancreatitis and pancreatic cancer pain. Curr Gastroenterol Rep. 2006 Apr;8(2):99-103. doi: 10.1007/s11894-006-0004-x.

  PMID: 16533471 BACKGROUND

• Comlek S. Pain Control with Splanchnic Neurolysis in Pancreatic Cancer Patients Unresponsive to Celiac Plexus Neurolysis. J Pain Res. 2020 Aug 12;13:2023-2031. doi: 10.2147/JPR.S266689. eCollection 2020.

  PMID: 32848449 BACKGROUND

• Yamamuro M, Kusaka K, Kato M, Takahashi M. Celiac plexus block in cancer pain management. Tohoku J Exp Med. 2000 Sep;192(1):1-18. doi: 10.1620/tjem.192.1.

  PMID: 11128864 BACKGROUND

• Paul A, Borkar A. Fluoroscopy-Guided Splanchnic Nerve Block for Cancer-Associated Pain. Cureus. 2022 Oct 31;14(10):e30944. doi: 10.7759/cureus.30944. eCollection 2022 Oct.

  PMID: 36465781 BACKGROUND

• Lu F, Li X, Song L, Ye L, Wang X, Wang R. Efficacy and Safety of Celiac Plexus Neurolysis Versus Splanchnic Nerve Neurolysis in the Management of Abdominal Cancer Pain: A Meta-analysis of 359 Patients. Pain Physician. 2024 Jan;27(1):1-10.

  PMID: 38285023 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Cancer Pain; Visceral Pain; Agnosia; Abdominal Pain

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nociceptive Pain; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Angela M Sousa, MD. PhD.

  Instituto do Cancer do Estado de São Paulo

  STUDY DIRECTOR

Central Study Contacts

Angela M Sousa, MD. PhD.

CONTACT

+55 1198558-8339; angela.sousa@hc.fm.usp.br

Karenthan A Rodrigues, MD.

CONTACT

+55 1199811-0737; karenthan.abreu@hc.fm.usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator of the Pain Group at the Instituto do Cancer do Estado de São Paulo.

Study Record Dates

• First Submitted: May 10, 2025
• First Posted: May 18, 2025
• Study Start: May 30, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 3, 2025

Record last verified: 2025-05

Locations

BR (1)