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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000346572
• Date of registration: 15/04/2015
• Prospective Registration: No
• Primary sponsor: Tanta University
• 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
• Date of first enrolment: 01/02/2015
• Target sample size: 30
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12615000346572.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial;

Countries of recruitment

Egypt

Contacts

• Name: A/Prof Yasser M. amr

• Name: A/Prof Yasser M. amr

Key inclusion & exclusion criteria

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.

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.


Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Cancer - Other cancer types

upper gastrointestinal cancer pain;
upper gastrointestinal cancer pain

Anaesthesiology - Pain management

Intervention(s)

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

Primary Outcome(s)

Upper gastrointestinal cancer pain as assessed using Visual Analogue Scale (VAS 0 - 10)[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(s)

Opioid consumption during the follow up period by patient self-report and pain physician report[data will be included in statistical analysis every 2 weeks for 4 months and then monthly for one year after the procedure. ]

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 [during the follow up period, i.e. up to 1 year post procedure]

Secondary ID(s)

nil known

Source(s) of Monetary Support

Yasser M. amr

Mohamed Y. Makharita

Ethics review

Status: Approved
Approval date:
Contact:

Faculty of medicine - mansoura university