RecruitingACTRN12615000346572

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

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


Sponsor

Tanta University

Enrollment

30 participants

Start Date

Feb 1, 2015

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether a nerve block procedure (called a celiac plexus block) guided by X-ray (fluoroscopy) can provide long-term pain relief for people with inoperable cancer of the upper digestive system, such as stomach, pancreas, or bile duct cancer. Pain from these cancers can be very severe and difficult to control with opioid medications alone. This nerve block targets the pain signals directly. You may be eligible if: - You are 18 years of age or older - You have been diagnosed with an inoperable upper gastrointestinal tumour (lower oesophagus, stomach, pancreas, or bile duct) - Your pain is severe and uncontrolled (score of 7 or more on a 0–10 pain scale) - You are already on the maximum tolerable dose of opioid pain medication You may NOT be eligible if: - You have a blood clotting disorder - You have a local skin infection at the needle insertion site - You have decompensated heart problems - You have unstable blood pressure or circulation - There is evidence of cancer spread (metastases) on imaging - You have a psychiatric disorder that affects your ability to cooperate - You have already had a previous nerve block that affects the severity of your current pain Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Thirty patients have inoperable upper gastrointestinal tumors including (cancer lower third esophagus, stomach, pancreas, biliary tract). Technique of modified trans-discal neurolytic celiac plexus

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.


Locations(1)

Egypt

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ACTRN12615000346572