Neurolytic Block Techniques In Abdominal Visceral Cancer Pain

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstituto do Cancer do Estado de São Paulo

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Procedure/Surgery

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

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

    Procedure/Surgery

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

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: CELIAC PLEXUS NEUROLYSISActive comparator 1 intervention
Group B: SPLANCHNIC NERVE NEUROLYSISExperimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Quality of life assessment.

Quality of life will be assessed using the Brief Pain Inventory - Short Form (SF-36) questionnaire, which evaluates both pain intensity and its impact on daily functioning. The questionnaire covers two main areas: Pain Severity - Patients rate their pain at its: Worst Least Average Current (right now) (using a 0-10 numeric scale, where 0 = no pain and 10 = pain as bad as you can imagine). Pain Interference - Assesses how much pain interferes with: General activity Mood Walking ability Normal work Relationships with others Sleep Enjoyment of life (also rated on a 0-10 scale, where 0 = does not interfere and 10 = completely interferes). Additionally, the questionnaire includes: A pain location diagram Information about current pain medications and their effectiveness Description of pain relief methods.

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

Adverse Events

Adverse events inherent to the studied procedures will be assessed and recorded. These include: Abdominal pain; Diarrhea; Hypotension (low blood pressure); Back pain; Nausea and vomiting; Fever; Bloating or abdominal distention; Delayed gastric emptying; Injury to surrounding structures (e.g., blood vessels or organs); Nerve damage; Impaired digestive function; Local infection at the puncture site; Loss of autonomic function; Pneumothorax.

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

Other outcomes

Sponsors and contacts

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