Back to resultsRadiofrequency and Chemical Neurolysis of Thoracic Splanchnic Nerve for Abdominal Cancer Pain (RF)
Primary Purpose
Abdominal Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Radiofrequency generator device
Lidocaine
C arm fluoroscopic device
Ethyl alcohol
Sponsored by
About this trial
This is an interventional supportive care trial for Abdominal Cancer
Eligibility Criteria
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.
Sites / Locations
- South Egypt Cancer InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Group 1( radiofrequency group )
Group 2 ( alcohol group )
Arm 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
Bilateral thoracic splanchnic nerves block will be performed by ethyl alcohol at one level of vertebraT11 by using of C arm fluoroscopic device.
Outcomes
Primary Outcome Measures
Pain relief
Visual analogue pain scale
Secondary Outcome Measures
Decrease the need for analgesic drugs
Reduction of total oral morphine consumption dose in mg per day
Full Information
NCT ID
NCT03063112
First Posted
February 10, 2017
Last Updated
February 26, 2017
Sponsor
South Egypt Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT03063112
Brief Title
Radiofrequency and Chemical Neurolysis of Thoracic Splanchnic Nerve for Abdominal Cancer Pain
Acronym
RF
Official Title
Comparative Study Between Radiofrequency Thermocoagulation and Chemical Neurolysis of Thoracic Splanchnic Nerve Bilaterally for the Management of Abdominal Cancer Pain
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
April 10, 2017 (Anticipated)
Study Completion Date
May 1, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Egypt Cancer Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
79 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1( radiofrequency group )
Arm Type
Active Comparator
Arm 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
Arm Title
Group 2 ( alcohol group )
Arm Type
Placebo Comparator
Arm Description
Bilateral thoracic splanchnic nerves block will be performed by ethyl alcohol at one level of vertebraT11 by using of C arm fluoroscopic device.
Intervention Type
Device
Intervention Name(s)
Radiofrequency generator device
Other Intervention Name(s)
Physical neurolysis
Intervention Description
sympathetic blockade or ablation of thoracic splanchnic nerves
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
sympathetic blockade or ablation of thoracic splanchnic nerves
Intervention Type
Device
Intervention Name(s)
C arm fluoroscopic device
Intervention Description
sympathetic blockade or ablation of thoracic splanchnic nerves
Intervention Type
Drug
Intervention Name(s)
Ethyl alcohol
Other Intervention Name(s)
Chemical neuolysis
Intervention Description
sympathetic blockade or ablation of thoracic splanchnic nerves
Primary Outcome Measure Information:
Title
Pain relief
Description
Visual analogue pain scale
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Decrease the need for analgesic drugs
Description
Reduction of total oral morphine consumption dose in mg per day
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fatma Al Zahraa H Abdel Hameed, Lecturer
Phone
0201063684819
Email
drfatmahamed15@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed H Othman, Professor
Phone
0201000525368
Email
ahmadhothman@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samy A Erfan, Professor
Organizational Affiliation
Head of the department
Official's Role
Study Director
Facility Information:
Facility Name
South Egypt Cancer Institute
City
Assuit
State/Province
Assuit governrate
ZIP/Postal Code
+20
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mostafa M Esharkawy, Professor
Phone
0882332016
Email
sru@seci.info
First Name & Middle Initial & Last Name & Degree
Doaa M Sayed, Professor
Phone
0882086671
Email
seci99999@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Radiofrequency and Chemical Neurolysis of Thoracic Splanchnic Nerve for Abdominal Cancer Pain
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