Radiofrequency and Chemical Neurolysis of Thoracic Splanchnic Nerve for Abdominal Cancer Pain
RF
Comparative Study Between Radiofrequency Thermocoagulation and Chemical Neurolysis of Thoracic Splanchnic Nerve Bilaterally for the Management of Abdominal Cancer Pain
1 other identifier
interventional
79
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 10, 2017
CompletedFirst Posted
Study publicly available on registry
February 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 10, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedFebruary 28, 2017
February 1, 2017
6 months
February 10, 2017
February 26, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Pain relief
Visual analogue pain scale
3 months
Secondary Outcomes (1)
Decrease the need for analgesic drugs
3 months
Study Arms (2)
Group 1( radiofrequency group )
ACTIVE COMPARATORBilateral 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
Group 2 ( alcohol group )
PLACEBO COMPARATORBilateral thoracic splanchnic nerves block will be performed by ethyl alcohol at one level of vertebraT11 by using of C arm fluoroscopic device.
Interventions
sympathetic blockade or ablation of thoracic splanchnic nerves
sympathetic blockade or ablation of thoracic splanchnic nerves
sympathetic blockade or ablation of thoracic splanchnic nerves
sympathetic blockade or ablation of thoracic splanchnic nerves
Eligibility Criteria
You may qualify if:
- 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 .
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
South Egypt Cancer Institute
Asyut, Assuit Governrate, +20, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Samy A Erfan, Professor
Head of the department
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of anasthesia and pain relief
Study Record Dates
First Submitted
February 10, 2017
First Posted
February 24, 2017
Study Start
October 1, 2016
Primary Completion
April 10, 2017
Study Completion
May 1, 2017
Last Updated
February 28, 2017
Record last verified: 2017-02