Combined Fluoroscopy and CT Guided Radiofrequency Ablation of Thoracic Dorsal Root Ganglia in Severe Thoracic Pain

NCT03533413 | Completed

• 1 other identifier: Raafat-Ehab.combined
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

In the current study, extra-guidance other than conventional fluoroscopy - will be integrated to improve the success of the transforaminal approach to the thoracic dorsal root ganglia (DRG). The investigators hypothesize that joining CT scan with fluoroscopy to guide RF ablation through the transforaminal route may enhance its efficacy and safety in relieving the intractable pain associated with chest malignancies. The current study aimed to compare the results of thermal radiofrequency ablation (TRFA) of the thoracic DRG under combined CT and fluoroscopy guidance with the classic standard fluoroscopy technique.

Conditions

Cancer-related Problem/Condition

Outcome Measures

Primary Outcomes (1)

• pain relief.

  Pain intensity measured by visual analog scale (VAS).It measures the pain intensity and percentage of pain relief.The investigators used 100 mm horizontal scale with left zero end representing no pain and right 100 end representing worst pain.Scores ranging 0-39 reflect mild pain , 40-69 moderate pain and 70-100 severe pain.

  12 weeks follow up

Secondary Outcomes (1)

• patient satisfaction.

  12 weeks

Study Arms (2)

Interventional:Combined CT-fluroscopy

ACTIVE COMPARATOR

Combined CT-fluroscopic radiofrequency ablation of thoracic dorsal root ganglia.

Procedure: combined CT-fluroscopy

Interventional: standard fluroscopy

ACTIVE COMPARATOR

Fluroscopic radiofrequency ablation of thoracic dorsal root ganglia.

Procedure: standard fluroscopy

Interventions

combined CT-fluroscopy PROCEDURE

Radiofrequency ablation of thoracic dorsal root ganglia guided by combined CT-Fluroscopy

Interventional:Combined CT-fluroscopy

standard fluroscopy PROCEDURE

Radiofrequency ablation of thoracic dorsal root ganglia guided by standard fluroscopy only

Interventional: standard fluroscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients aged 18 years or more
• suffering from chronic moderate-to-severe pain ( VAS score ≥ 40 mm)
• due to malignancy involving the chest and pain was refractory to the maximally tolerated dose of opioids for at least four weeks. Malignancies included : lung cancer, pleural mesothelioma, chest wall tumors and metastatic deposits of the chest.

You may not qualify if:

• sepsis, coagulopathy
• malignant epidural invasion
• distorted local anatomy
• severe cardiorespiratory compromise
• neuropsychiatric illness
• history of drug dependence and known allergy to contrast media or the used medications.

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

Department of Anesthesia and Pain medicine.National Cancer Institute

Cairo, 11796, Egypt

Location

Related Publications (1)

• Reyad RM, Ghobrial HZ, Shaker EH, Reyad EM, Shaaban MH, Hashem RH, Darwish WM. Modified technique for thermal radiofrequency ablation of Thoracic dorsal root ganglia under combined fluoroscopy and CT guidance: a randomized clinical trial. BMC Anesthesiol. 2019 Dec 18;19(1):234. doi: 10.1186/s12871-019-0906-4.

  PMID: 31852438 DERIVED

Related Links

• clinical journal of pain

Study Officials

• Ehab H Shaker, MD

  National Cancer Institute- Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia ,critical care and pain medicine

Study Record Dates

• First Submitted: April 22, 2018
• First Posted: May 23, 2018
• Study Start: April 1, 2017
• Primary Completion: October 31, 2017
• Study Completion: November 30, 2017
• Last Updated: May 30, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)