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

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.

Study Overview

• Status: Unknown
• Conditions: Abdominal Cancer
• Intervention / Treatment: Device: Radiofrequency generator device; Drug: Lidocaine; Device: C arm fluoroscopic device; Drug: Ethyl alcohol

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.

• Study Type: Interventional
• Enrollment (Anticipated): 79
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fatma Al Zahraa H Abdel Hameed, Lecturer; Phone Number: 0201063684819; Email: drfatmahamed15@gmail.com
• Study Contact Backup: Name: Ahmed H Othman, Professor; Phone Number: 0201000525368; Email: ahmadhothman@gmail.com

Study Locations

• Egypt
  • Assuit governrate
    • Assuit, Assuit governrate, Egypt, +20
      • Recruiting
      • South Egypt Cancer Institute
      • Contact: Mostafa M Esharkawy, Professor; Phone Number: 0882332016; Email: sru@seci.info
      • Contact: Doaa M Sayed, Professor; Phone Number: 0882086671; Email: seci99999@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Group 1( radiofrequency group ); 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	Device: Radiofrequency generator device; sympathetic blockade or ablation of thoracic splanchnic nerves; Other Names: Physical neurolysis; Drug: Lidocaine; sympathetic blockade or ablation of thoracic splanchnic nerves
PLACEBO_COMPARATOR: Group 2 ( alcohol group ); Bilateral thoracic splanchnic nerves block will be performed by ethyl alcohol at one level of vertebraT11 by using of C arm fluoroscopic device.	Device: C arm fluoroscopic device; sympathetic blockade or ablation of thoracic splanchnic nerves; Drug: Ethyl alcohol; sympathetic blockade or ablation of thoracic splanchnic nerves; Other Names: Chemical neuolysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain relief	Visual analogue pain scale	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease the need for analgesic drugs	Reduction of total oral morphine consumption dose in mg per day	3 months

Collaborators and Investigators

• Sponsor: South Egypt Cancer Institute
• Investigators: Study Director: Samy A Erfan, Professor, Head of the Department

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2016
• Primary Completion (ANTICIPATED): April 10, 2017
• Study Completion (ANTICIPATED): May 1, 2017

Study Registration Dates

• First Submitted: February 10, 2017
• First Submitted That Met QC Criteria: February 23, 2017
• First Posted (ACTUAL): February 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 28, 2017
• Last Update Submitted That Met QC Criteria: February 26, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Pain; Neurologic Manifestations; Abdominal Neoplasms; Cancer Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Ethanol; Lidocaine
• Other Study ID Numbers: Ethical committee 167

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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