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

South Egypt Cancer Institute

Status: Unknown

Conditions: Abdominal Cancer

Treatments: Drug: Lidocaine; Device: C arm fluoroscopic device; Drug: Ethyl alcohol; Device: Radiofrequency generator device

Study type: Interventional

Funder types: Other

Identifiers

NCT03063112

Ethical committee 167

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 79 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients suffering from upper abdominal cancer pain.
2. Visceral pain with visual analogue pain score ≥ 4.
3. Normal coagulation profile.
4. Positive diagnostic test.
5. Written informed consent from the patients .

Exclusion criteria

1. Patients with organ failure.
2. Coagulation disorders.
3. Local infection at the puncture site or sepsis.
4. Allergy to the contrast dye or alcohol.
5. Severe displacement of intra-abdominal structures.
6. Pregnant women.
7. Documented metastatic lesions.
8. Psychiatric illness affecting cooperation.
9. De-compensated cardiac disorders.
10. Liver and renal dysfunction.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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79 participants in 2 patient groups, including a placebo group

Group 1( radiofrequency group )

Active Comparator group

Description:

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

Treatment:

Device: Radiofrequency generator device

Drug: Lidocaine

Group 2 ( alcohol group )

Placebo Comparator group

Description:

Bilateral thoracic splanchnic nerves block will be performed by ethyl alcohol at one level of vertebraT11 by using of C arm fluoroscopic device.

Treatment:

Device: C arm fluoroscopic device

Drug: Ethyl alcohol