Abdominal Cancer
Conditions
Brief summary
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
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.
Interventions
DEVICERadiofrequency generator device
sympathetic blockade or ablation of thoracic splanchnic nerves
DRUGLidocaine
sympathetic blockade or ablation of thoracic splanchnic nerves
DEVICEC arm fluoroscopic device
sympathetic blockade or ablation of thoracic splanchnic nerves
DRUGEthyl alcohol
sympathetic blockade or ablation of thoracic splanchnic nerves
Sponsors
South Egypt Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain relief | 3 months | Visual analogue pain scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Decrease the need for analgesic drugs | 3 months | Reduction of total oral morphine consumption dose in mg per day |
Countries
Egypt
Contacts
Primary ContactFatma Al Zahraa H Abdel Hameed, Lecturer
Backup ContactAhmed H Othman, Professor
Outcome results
None listed