Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03063112
Other study ID # Ethical committee 167
Secondary ID
Status Recruiting
Phase N/A
First received February 10, 2017
Last updated February 26, 2017
Start date October 1, 2016
Est. completion date May 1, 2017

Study information

Verified date February 2017
Source South Egypt Cancer Institute
Contact Fatma Al Zahraa H Abdel Hameed, Lecturer
Phone 0201063684819
Email drfatmahamed15@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 79
Est. completion date May 1, 2017
Est. primary completion date April 10, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
Radiofrequency generator device
sympathetic blockade or ablation of thoracic splanchnic nerves
Drug:
Lidocaine
sympathetic blockade or ablation of thoracic splanchnic nerves
Device:
C arm fluoroscopic device
sympathetic blockade or ablation of thoracic splanchnic nerves
Drug:
Ethyl alcohol
sympathetic blockade or ablation of thoracic splanchnic nerves

Locations

Country Name City State
Egypt South Egypt Cancer Institute Assuit Assuit governrate

Sponsors (1)

Lead Sponsor Collaborator
South Egypt Cancer Institute

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain relief Visual analogue pain scale 3 months
Secondary Decrease the need for analgesic drugs Reduction of total oral morphine consumption dose in mg per day 3 months
See also
  Status Clinical Trial Phase
Recruiting NCT03144622 - 18F-FSPG PET/CT Imaging in Patients With Cancers
Completed NCT04553471 - Palliative Lattice Stereotactic Body Radiotherapy (SBRT) for Patients With Sarcoma, Thoracic, Abdominal, and Pelvic Cancers N/A
Completed NCT02566096 - Efficacy of Transverses Abdominis -Plane Block With Bupivacaine Versus Bupivacaine With Morphine Postoperatively Phase 4
Recruiting NCT05533424 - Ultrasound Guided Quadratus Lumborum Block Versus Transversus Abdominis Plane Block as Postoperative Analgesia in Patients Undergoing Abdominal Cancer Surgery. Phase 3
Completed NCT04729634 - Survey Of Mobilisation and Breathing Exercises After Thoracic and Abdominal Surgery N/A
Completed NCT04152564 - Cardio-pulmonary and Analgesic Effects of Pre-peritoneal VS Epidural Infusion of L-bupivacaine on Abd. Cancer Patients N/A
Completed NCT03555266 - NSS-2 BRIDGE Device in Post-Operative Pain Management N/A
Active, not recruiting NCT00493688 - A Study to Determine Whether Perioperative Energy Dynamics Correlates With Postoperative Outcomes
Withdrawn NCT04114422 - A Seven-day Preoperative Exercise Training Program in People With Abdominal Cancer N/A
Recruiting NCT04199754 - IV Contrast-Enhanced Cone Beam Computed Tomography (CBCT) in Radiotherapy Early Phase 1
Completed NCT02998736 - Trial of Perioperative Tadalafil and Influenza Vaccination in Cancer Patients Undergoing Major Surgical Resection of a Primary Abdominal Malignancy Phase 1
Completed NCT00780611 - Investigating the Improvement in 4D CT Images Using AV Biofeedback
Completed NCT00415675 - Respiratory Tumor and Normal Tissue Motion N/A
Not yet recruiting NCT05903430 - A Feasibility Study of MRI Guided Stereotactic Ablative Radiotherapy (MIDSECTION)
Completed NCT03751384 - Improvement of Compliance for High Doses of EPA Amongst Patients With Colorectal Cancer N/A
Recruiting NCT05219058 - Reconstruction in Extended MArgin Cancer Surgery
Completed NCT03102619 - Wireless Assessment of Respiratory and Circulatory Distress; A Pilot Study N/A
Not yet recruiting NCT06265948 - Comparsion Between Intravenous Infusion of Ketofol and Inhalational Anasthetics in Abdominal Cancer Surgeries for Post Operative Analgesia
Completed NCT05524454 - Evaluation of a Cone-beam CT Scanner for Image Guided Radiotherapy N/A
Completed NCT04316871 - Dosage of Epidural Morphine in Elderly Patients Phase 4