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

Abdominal Cancer Clinical Trial

— RF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03063112
• Other study ID #: Ethical committee 167
• Status: Recruiting
• Phase: N/A
• First received: February 10, 2017
• Last updated: February 26, 2017
• Start date: October 1, 2016
• Est. completion date: May 1, 2017

Study information

• Verified date: February 2017
• Source: South Egypt Cancer Institute
• Contact: Fatma Al Zahraa H Abdel Hameed, Lecturer
• Phone: 0201063684819
• Email: drfatmahamed15[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 79
• Est. completion date: May 1, 2017
• Est. primary completion date: April 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Cancer
• Abdominal Neoplasms

Intervention

Device:
• Radiofrequency generator device
sympathetic blockade or ablation of thoracic splanchnic nerves

Drug:
• Lidocaine
sympathetic blockade or ablation of thoracic splanchnic nerves

Device:
• C arm fluoroscopic device
sympathetic blockade or ablation of thoracic splanchnic nerves

Drug:
• Ethyl alcohol
sympathetic blockade or ablation of thoracic splanchnic nerves

Locations

Country	Name	City	State
Egypt	South Egypt Cancer Institute	Assuit	Assuit governrate

Sponsors (1)

Lead Sponsor	Collaborator
South Egypt Cancer Institute

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain relief	Visual analogue pain scale	3 months
Secondary	Decrease the need for analgesic drugs	Reduction of total oral morphine consumption dose in mg per day	3 months