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

Not Applicable

• Conditions: Abdominal Cancer
• Interventions: Device: C arm fluoroscopic device; Device: Radiofrequency generator device; Drug: Lidocaine; Drug: Ethyl alcohol

• Registration Number: NCT03063112
• Lead Sponsor: South Egypt Cancer Institute

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.

Study Timeline

• Study Start: 2016-10-01
• Status Verified: 2017-02
• Study First Submitted: 2017-02-10
• Study First Submitted QC: 2017-02-23
• Study First Posted: 2017-02-24
• Last Update Submitted: 2017-02-26
• Last Update Posted: 2017-02-28
• Primary Completion: 2017-04-10
• Study Completion: 2017-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 79

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2 ( alcohol group )	C arm fluoroscopic device	Bilateral thoracic splanchnic nerves block will be performed by ethyl alcohol at one level of vertebraT11 by using of C arm fluoroscopic device.
Group 1( radiofrequency group )	Radiofrequency generator device	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
Group 1( radiofrequency group )	Lidocaine	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
Group 2 ( alcohol group )	Ethyl alcohol	Bilateral thoracic splanchnic nerves block will be performed by ethyl alcohol at one level of vertebraT11 by using of C arm fluoroscopic device.

Primary Outcome Measures

Name	Time	Method
Pain relief	3 months	Visual analogue pain scale

Secondary Outcome Measures

Name	Time	Method
Decrease the need for analgesic drugs	3 months	Reduction of total oral morphine consumption dose in mg per day

Trial Locations

Locations (1)

South Egypt Cancer Institute; 🇪🇬 Assuit, Assuit governrate, Egypt