ClinicalTrials.gg
CompletedNCT02692456Updated Feb 26, 2016

Effect of Patient Position on Computerized Tomography Guided Celiac Trunk Neurolysis

An interventional study of Double needle celiac neurolysis (DNCN) and Single needle celiac neurolysis (SNCN) in Upper Abdominal Malignancy, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-26.

Sponsored by Mansoura University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Computerized tomography-guided Celiac plexus neurolysis has become a popular technique. As, it has Cross-section imaging system to avoids anatomic structures injury, it has high density resolution that clearly display the retro-peritoneal anatomic structures ,it allow an optimal puncture site selection and measured the angle and depth of the needle insertion accurately with display the range of the neurolytic agent diffusion

Read the detailed description

The aim of this study was to evaluate analgesic efficacy of a computerized tomography guided left lateral antero-crural approach near the origin of celiac trunk with patients position on their right side immediately after the procedure using a single needle injection technique for upper abdominal malignancy compared with the classic 2 needle posterior antero-crural injection technique and possible complications.

All patients will take thin computerized tomography section in the axial plane to detect the site of celiac plexus and coronal plane for correct site for needle placement.

Computerized tomography slices thickness will be from 3 mm at 5mm interval through all the abdominal and lower thoracic area. The celiac and superior mesenteric arteries will be identified after contrast injection.

When an ideal needle position and tip were confirmed, the stylet was removed and aspiration was performed to ensure that there was no blood is withdrawn.

A volume of 3 ml of lidocaine mixed with contrast was injected to confirm the position, after injection another cut has been taken to show the spread of contrast freely in the retro-peritoneal space around the celiac plexus and the aorta. After confirmation, that contrast was injected to surround the artery and make sure that there was no dorsal spread to avoid injury to somatic nerves. Also to make sure that there was no spread to the renal pelvis , injection of phenol 10% mixed with contrast through needle

02

Conditions studied

  • Upper Abdominal Malignancy
03

In context

Lead sponsor

Mansoura University is the lead sponsor of 1,115 studies on the registry; 184 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with gastric carcinoma
  • Patients with hepato-biliary-pancreatic cancer
  • Patients with colonic malignancy
  • Patients with peritoneal metastasis
  • Patients with extensive hepatic metastasis
  • Patients having intractable pain to opioids and other analgesics.
  • Patients experienced adverse effects to opioids or other analgesics.
  • Patients experienced improved intractable pain after diagnostic celiac plexus block

Exclusion criteria

Exclusion Criteria:

  • Patient's refusal
  • Patients with bleeding tendency
  • Patients with coagulopathy
  • Patients who were benefited from oral analgesics with no serious side effects
  • Patients with significant cardiac diseases
  • Patients with organ failure
  • Patients with distant vertebral metastasis
  • Evidence of local infection at the puncture site
  • Patients who did not experience improved pain after receiving a diagnostic celiac plexus block
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
34 participants (actual)

Study arms

  • Active comparator
    Double needle celiac neurolysis (DNCN)

    Patients were subjected to CT guided celiac neurolysis using 2 needle antero-crural technique on each side with patient in prone position and both needles will be lateral to the aorta

    Device: Double needle celiac neurolysis (DNCN)

  • Placebo comparator
    Single needle celiac neurolysis (SNCN)

    Patients were subjected to CT guided celiac neurolysis using a single needle antero-crural approach from left side to be just in the front of the aorta near the origin of celiac trunk with patient in lateral position with his left side up then after the injection the patient were kept to his right side up for more homogenous spread of the dye.

    Device: Single needle celiac neurolysis (SNCN)

Interventions

  • DeviceDouble needle celiac neurolysis (DNCN)

    CT guided celiac neurolysis will be performed using 2 needles inserted on each sides of aorta where patient was positioned in prone position

  • DeviceSingle needle celiac neurolysis (SNCN)

    CT guided celiac neurolysis will be performed through advancing a single needle to justfront of the aorta near the origin of celiac trunk where patient placed in lateral position

06

What researchers measure

Primary outcomes

  1. Failure rate of patients positioning

    Positioning failure means failure to put patient in prone or lateral position

    Time frame: For 5 min before needle insertion

Secondary outcomes

  1. Time to achieve analgesia

    Time to achieve pain score less than 3

    Time frame: for one hour after performing the procedure

  2. Failure of block

    Failure of block is defined as patient having pain visual analogue scale greater than 3

    Time frame: For 1 week after performing the procedure

07

Study locations

1 site
  • Mansoura University Cancer Institute
    Al Mansurah, DK 050, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2015, a primary completion of Dec 2015 and a completion of Dec 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 5, 2016
First posted
Feb 26, 2016
Start
Jun 2015
Primary completionActual
Dec 2015
CompletionActual
Dec 2015
Last update
Feb 26, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 26, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02692456
Responsible party
Sponsor
First posted
Feb 26, 2016
Start date
Jun 2015
Primary completion
Dec 2015
Completion
Dec 2015
Last update
Feb 26, 2016

Study contacts

Alaa A Elmaadawy, MD
study director · Lecturer of Anesthesia and Surgical Intensive Care
Ghada F EL-Rahmawy, MD
principal investigator · Professor of Anesthesia and Surgical Intensive Care
Nevert A Abdelghaffar, MD
study chair · lecturer of Anesthesia and Surgical Intensive Care

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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