Radiofrequency and Chemical Neurolysis of Thoracic Splanchnic Nerve for Abdominal Cancer Pain

Study Overview
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Brief Summary
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The study compares between the efficacy, safety and impact on the quality of life of radiofrequency thermocoagulation and chemical neurolysis of bilateral thoracic splanchnic nerves in the management of refractory pain which developed in patients suffering from upper abdominal cancer.

Detailed Description
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Radiofrequency thermocoagulation of splanchnic nerves was done bilaterally at level of thoracic vertebra T10 and T11 ( there were no enough studies done to test the efficacy, safety and impact on the quality of life of radiofrequency thermocoagulation of splanchnic nerves at level of T10 ). Aim of the Study is to compare between the efficacy, safety and impact on the quality of life of radiofrequency thermocoagulation of bilateral thoracic splanchnic nerves at level T10 and T11 vertebra and chemical neurolytic block of them at level of T11 vertebra only in the management of upper abdominal cancer pain.

Official Title
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Comparative Study Between Radiofrequency Thermocoagulation and Chemical Neurolysis of Thoracic Splanchnic Nerve Bilaterally for the Management of Abdominal Cancer Pain

Conditions
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Abdominal Cancer

Intervention / Treatment
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* Device: Radiofrequency generator device
* Drug: Lidocaine
* Device: C arm fluoroscopic device
* Drug: Ethyl alcohol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients suffering from upper abdominal cancer pain. Visceral pain with visual analogue pain score ≥ 4. Normal coagulation profile. Positive diagnostic test. Written informed consent from the patients . Exclusion Criteria: Patients with organ failure. Coagulation disorders. Local infection at the puncture site or sepsis. Allergy to the contrast dye or alcohol. Severe displacement of intra-abdominal structures. Pregnant women. Documented metastatic lesions. Psychiatric illness affecting cooperation. De-compensated cardiac disorders. Liver and renal dysfunction.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1( radiofrequency group )<br>Bilateral thoracic splanchnic nerves block will be performed by radiofrequency thermocoagulation at two level of vertebra T10 and T11 by using radiofrequency generator device and lidocaine 2% before thermal lesion | Device: Radiofrequency generator device<br>* sympathetic blockade or ablation of thoracic splanchnic nerves<br>* Other names: Physical neurolysis;Drug: Lidocaine<br>* sympathetic blockade or ablation of thoracic splanchnic nerves<br>|
| Placebo Comparator: Group 2 ( alcohol group )<br>Bilateral thoracic splanchnic nerves block will be performed by ethyl alcohol at one level of vertebraT11 by using of C arm fluoroscopic device. | Device: C arm fluoroscopic device<br>* sympathetic blockade or ablation of thoracic splanchnic nerves<br>Drug: Ethyl alcohol<br>* sympathetic blockade or ablation of thoracic splanchnic nerves<br>* Other names: Chemical neuolysis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain relief | Visual analogue pain scale | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease the need for analgesic drugs | Reduction of total oral morphine consumption dose in mg per day | 3 months |