Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201902902555639 Date of Approval: 21/02/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ultrasound guided pulsed radiofrequency for thoracic dorsal root ganglia to control thoracic cage pain of metastatic lung cancer
Official scientific title Ultrasound guided pulsed radiofrequency for thoracic dorsal root ganglia to control thoracic cage pain of metastatic lung cancer
Brief summary describing the background and objectives of the trial Thoracic cage metastasis is one of the most common sites of metastasis in the patients with lung cancer. Pain associated with tumor invasion of rib and intercostal nerve, pathological fracture and pleural irritation is severe and difficult to treat. When an adequate pharmacological medical management fails to provide satisfactory analgesia or when it causes side effects, interventional cancer pain techniques may be considered. The aim of this study is to investigate the effect of ultrasound guided pulsed radiofrequency of thoracic dorsal root ganglion on the pain and functionality of lung cancer patients with thoracic cage metastasis.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 03/03/2019
Actual trial start date 03/03/2019
Anticipated date of last follow up 03/03/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group pulsed radiofrequency plus lidocaine group Radiofrequency session plus 0.5 ml of 2% lidocaine 8 minutes Ultrasound guided pulsed radiofrequency of thoracic dorsal root ganglion for 8 minutes followed by 0.5 ml lidocaine 20% for each affected dermatome 15
Control Group Lidocaine group 0.5 ml of 2% lidocaine Once 0.5 ml lidocaine 20% for each affected dermatome 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
American Society of Anesthesiology Physical Status I, II or III. Patient refusal, uncooperative patient. Concomitant medical or psychiatric illness. Systemic or local infection. Patients with opioid addiction or drug seeking behavior. Bleeding disorders. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/01/2019 Ethical Committee Medical Research Institute University of Alexandria
Ethics Committee Address
Street address City Postal code Country
165 Horreya Avenus, Hadara Alexandria 21561 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Visual analogue scale (VAS) Post-procedure immediately Post-procedure at 1,3,7 days
Secondary Outcome Enhanced patient's quality of life. 2 weeks, 1 month, 2 months and 3 months
Secondary Outcome Improvement of Brief pain inventory scale. 2 weeks, 1 month, 2 months and 3 months
Secondary Outcome Decrease analgesic consumption 2 weeks, 1 month, 2 months and 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Anesthesia and Pain Management Medical Research Institute Alexandria University 165 Elhoryea Street Elhadara Alexandria 21561 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dina Kamel Abdel Maksoud 165 Horreya Aenus Hadara Alexandria 21561 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Anesthesia and Pain Management Medical Research Institute Alexandria University 165 Horreya Avenus Hadara Alexandria 21561 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Nagwa Ahmed Megahed 165 Horreya Avenus Hadara Alexandria 21561 Egypt
Sahar Ahmed ElKaradawy 165 Horreya Avenus Hadara Alexandria 21561 Egypt
Dina Nabil Abbas Al Kasr Al Aini, Fom Al Khalig WA Deir an Nahas, Misr Al Qadimah Cairo 11562 Egypt
Nancy Mohamed Ali Elsekily Fahmy Abdel Magid St EL HADARA Qesm Bab Sharqi Alexandria 21561 Egypt
Assem Yousef Rostom Acacia St, Abis, Qism Moharram Bek, Alexandria 21643 Egypt
Dina Kamel Abdel Maksoud 165 Horreya Avenus Hadara Alexandria 21561 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dina Kamel Dinakamel_83@yahoo.com 002012224266735 165 Horreya Avenus Hadara
City Postal code Country Position/Affiliation
Alexandria 21561 Egypt Specialist of anesthesia Damanhour Medical National Institute
Role Name Email Phone Street address
Scientific Enquiries sahar Elkaradawy Sahar.Elkaradwy.Ana@gmail.com 00201067940614 165 Horreya Avenus Hadara
City Postal code Country Position/Affiliation
Alexandria 21561 Egypt Professor of Anesthesia and Pain Management Medical Research Institute University of Alexandria
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information