Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000346572
Ethics application status
Approved
Date submitted
2/12/2014
Date registered
15/04/2015
Date last updated
23/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of fluoroscopic guided single needle trans-discal approach for celiac plexus block in patients with upper gastrointestinal tumours on pain relief; one year follow up
Scientific title
Safety and efficacy of fluoroscopic guided modified single needle trans-discal approach for neurolytic retrocrural celiac plexus block in patients with inoperable upper gastrointestinal cancer pain
Secondary ID [1] 285774 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
upper gastrointestinal cancer pain 293656 0
Condition category
Condition code
Anaesthesiology 293954 293954 0 0
Pain management
Cancer 294250 294250 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Thirty patients have inoperable upper gastrointestinal tumors including (cancer lower third esophagus, stomach, pancreas, biliary tract).
Technique of modified trans-discal neurolytic celiac plexus block procedure it will be undertaken in each patient on a single occasion only:
Step1. Position and monitor the patient
Place the patient prone on the table. Place a pillow under the abdomen to flex the thoraco-lumbar spine. The patient’s head is turned to the side, and the arms are permitted to hang freely off each side of the table.
Oxygen is provided by nasal cannula.
Monitoring of vital signs is mandatory heart rate, blood pressure, oxygen saturation.
The area extended from inferior border of the scapula to iliac creast will be sterilized by bovine iodine and trapped in sterile fashion.
Step2. Equipment and drugs for the technique
10 ml syringe for local anesthetic 2 % xylocaine.
10 ml syringes for neurolytic agent (alchole 70%).
One 15 cm, 22 gauge CHIBA needle for Celiac block.
5 ml syringe for the contrast material ( omnipaque 300mg/ml).
1% xylocaine for skin infiltration.
Step3. Visualization
The body of T12 and L1vertebra will be identified in the postero-anterior view of fluoroscopy keeping a mark on space between T12-L1, then, in a caudo-cephalic direction to achieve alignment of the vertebral body of L12- L1 disc space.
Rotate fluoroscope to an oblique position ipsilateral (20 - 40 degree) guided by entrance of facetal line between T12 and L1 toward midline.
Step 4 . Direction of the needle
Skin infiltration will be made just lateral to superior articular process of T12.
Needle insertion at this point till feeling gritty sensation of disc enterance. Then, turn C- arm to lateral position to evaluate passage of the needle through disc space. While advancing the needle, loss of resistance will be confirmed using saline till penetrating the disc. Now position the C -arm for the postero-anterior view again to verify the midline position of the needle with the vertebral body.
Aspirate for blood. If the aspiration test is positive, withdraw and redirect the needle.
Step 5 . Confirm the position of the needle
Inject 5 ml of (omnipaque 300mg/ml). On the postero-anterior view the contrast material will spread adhering to the T12, L1 vertebral body. A smooth contoured image will appear in the lateral view; the tip on the lateral view should stay retrocrural to the aorta.
Step 6 . Celiac block
Inject 3ml of xylocaine 2% via CHIBA needle.
Inject 40 ml of 70% alcohol via needle and then, inject 1ml of 0.9% of normal saline during needle withdrawal to avoid track formation.
Intervention code [1] 290733 0
Treatment: Drugs
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293727 0
Upper gastrointestinal cancer pain as assessed using Visual Analogue Scale (VAS 0 - 10)
Timepoint [1] 293727 0
patients will be evaluated personally in pain clinic every two weeks and by telephone every week (to evaluate patient generally and if there is any need for early date as incidence of severe pain, change character of pain or side effects). Pain intensity will be determined by asking the patients to record the scale (VAS) daily on a paper given to them from the clinic and the observer will calculate the average weekly. However, data will be included in statistical analysis at preprocedure, then every 2 weeks for 4 months and then monthly for one year
Secondary outcome [1] 311682 0
Opioid consumption during the follow up period by patient self-report and pain physician report
Timepoint [1] 311682 0
data will be included in statistical analysis every 2 weeks for 4 months and then monthly for one year after the procedure.
Secondary outcome [2] 311683 0
opioids side effects, including loss of appetite, nausea or vomiting, insomnia, constipation, urinary retention, pruritis will be evaluated and subjectively determined by each patient. Incidence of side effects as will be informed by the patient and if it will be find moderate to severe degree and require medications, changing opioid regimen or tapering the dose down, it will be reported in the results
Timepoint [2] 311683 0
during the follow up period, i.e. up to 1 year post procedure

Eligibility
Key inclusion criteria
1- Thirty patients have inoperable upper gastrointestinal tumors including (cancer lower third esophagus, stomach, pancreas, biliary tract).
2- With uncontrolled visceral pain (Visual analogue scale greater than or equal to 7/10).
3- With maximum tolerable dose of opioids.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1-Patients have coagulopathy.
2- Patients have local infection at the area of needle insertion.
3- Decompensate cardiac disorders.
4- Hemodynamic instability.
5- Radiological evident metastatic lesions.
6- Psychiatric disorders affecting cooperation.
7- Has undergone previous blocks affecting severity of the present pain.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
The chi-square test and Fisher's exact test will be used for qualitative parameters. Data shown as means +/- SD will be analyzed by Student's t test. Mean values will be rounded off to the nearest whole number. Statistical analysis will base on intention to treat analysis by substituting the missing data due to patients' death by the last reported data. A significant difference was accepted when P < 0.05.
This study will be a preliminary one to test the validity of the technique. The number of participants needed to achieve study objectives was determined, based on previous clinical study of the author which supported that 30 patients is enough to detect statistical significant difference in visual analogue scale
Amr YM, Makharita MY. Comparative study between 2 protocols for management of severe pain in patients with unresectable pancreatic cancer: one-year follow-up. Clin J Pain. 2013 Sep;29:807-13.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2015
Actual
1/02/2015
Date of last participant enrolment
Anticipated
30/03/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 6505 0
Egypt
State/province [1] 6505 0

Funding & Sponsors
Funding source category [1] 290338 0
Self funded/Unfunded
Name [1] 290338 0
Yasser M. amr
Country [1] 290338 0
Egypt
Funding source category [2] 290586 0
Self funded/Unfunded
Name [2] 290586 0
Mohamed Y. Makharita
Country [2] 290586 0
Egypt
Primary sponsor type
University
Name
Tanta University
Address
Faculty of Medicine, Tanta University, Tanta city- EL BAHR street- Egypt. Zip code : 31527
Country
Egypt
Secondary sponsor category [1] 289057 0
None
Name [1] 289057 0
Address [1] 289057 0
Country [1] 289057 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292043 0
Faculty of medicine - mansoura university
Ethics committee address [1] 292043 0
Faculty Of Medicine - El Mansoura University - 60 El Gomhoureya St.
El Mansoura, El Dakahleya
Post code 35516
Ethics committee country [1] 292043 0
Egypt
Date submitted for ethics approval [1] 292043 0
14/11/2014
Approval date [1] 292043 0
01/12/2014
Ethics approval number [1] 292043 0
R/100

Summary
Brief summary
This study will be performed to evaluate modified single needle transdiscal approach to perform fluoroscopic guided retro-crural celiac plexus block regarding safety and efficacy for one year after interventional procedure for patients with upper gastrointestinal (GIT) tumors.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53210 0
A/Prof Yasser M. amr
Address 53210 0
El BAHR street, Tanta, Gharbia, Faculty of Medicine, Tanta University, 31527 Egypt
Country 53210 0
Egypt
Phone 53210 0
+201224462887
Fax 53210 0
Email 53210 0
yasser.amr@gmail.com
Contact person for public queries
Name 53211 0
A/Prof Yasser M. amr
Address 53211 0
El BAHR street, Tanta, Gharbia, Faculty of Medicine, Tanta University, 31527 Egypt
Country 53211 0
Egypt
Phone 53211 0
+201224462887
Fax 53211 0
Email 53211 0
yasser.amr@gmail.com
Contact person for scientific queries
Name 53212 0
A/Prof Yasser M. amr
Address 53212 0
El BAHR street, Tanta, Gharbia, Faculty of Medicine, Tanta University, 31527 Egypt
Country 53212 0
Egypt
Phone 53212 0
+201224462887
Fax 53212 0
Email 53212 0
yasser.amr@gmail.com

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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