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

NCT ID: NCT03063112

Last Updated: 2017-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-01

Study Completion Date

2017-05-01

Brief Summary

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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

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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.

Conditions

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Abdominal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Radiofrequency generator device

Intervention Type DEVICE

sympathetic blockade or ablation of thoracic splanchnic nerves

Lidocaine

Intervention Type DRUG

sympathetic blockade or ablation of thoracic splanchnic nerves

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.

Group Type PLACEBO_COMPARATOR

C arm fluoroscopic device

Intervention Type DEVICE

sympathetic blockade or ablation of thoracic splanchnic nerves

Ethyl alcohol

Intervention Type DRUG

sympathetic blockade or ablation of thoracic splanchnic nerves

Interventions

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Radiofrequency generator device

sympathetic blockade or ablation of thoracic splanchnic nerves

Intervention Type DEVICE

Lidocaine

sympathetic blockade or ablation of thoracic splanchnic nerves

Intervention Type DRUG

C arm fluoroscopic device

sympathetic blockade or ablation of thoracic splanchnic nerves

Intervention Type DEVICE

Ethyl alcohol

sympathetic blockade or ablation of thoracic splanchnic nerves

Intervention Type DRUG

Other Intervention Names

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Physical neurolysis Chemical neuolysis

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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South Egypt Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Fatma Al Zahraa Hamed Abdel Hameed

Lecturer of anasthesia and pain relief

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Samy A Erfan, Professor

Role: STUDY_DIRECTOR

Head of the department

Locations

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South Egypt Cancer Institute

Asyut, Assuit Governrate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Fatma Al Zahraa H Abdel Hameed, Lecturer

Role: CONTACT

Phone: 0201063684819

Email: [email protected]

Ahmed H Othman, Professor

Role: CONTACT

Phone: 0201000525368

Email: [email protected]

Facility Contacts

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Mostafa M Esharkawy, Professor

Role: primary

Doaa M Sayed, Professor

Role: backup

Other Identifiers

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Ethical committee 167

Identifier Type: -

Identifier Source: org_study_id