Effect of Patient Position on Computerized Tomography Guided Celiac Trunk Neurolysis

Efficacy of Patient Position After Computerized Tomography Guided Antero-crural Celiac Trunk Neurolysis on Upper Abdominal Malignancy Pain

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

Study Overview

• Status: Completed
• Conditions: Upper Abdominal Malignancy
• Intervention / Treatment: Device: Double needle celiac neurolysis (DNCN); Device: Single needle celiac neurolysis (SNCN)

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and tip were confirmed, the stylet was removed and aspiration was performed to ensure that there was no blood is withdrawn.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

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • DK
    • Mansoura, DK, Egypt, 050
      • Mansoura University Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); CT guided celiac neurolysis will be performed using 2 needles inserted on each sides of aorta where patient was positioned in prone position
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); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Failure rate of patients positioning	Positioning failure means failure to put patient in prone or lateral position	For 5 min before needle insertion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to achieve analgesia	Time to achieve pain score less than 3	for one hour after performing the procedure
Failure of block	Failure of block is defined as patient having pain visual analogue scale greater than 3	For 1 week after performing the procedure

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Director: Alaa A Elmaadawy, MD, Lecturer of anesthesia and surgical intensive care; Principal Investigator: Ghada F EL-Rahmawy, MD, Professor of Anesthesia and Surgical Intensive Care; Study Chair: Nevert A Abdelghaffar, MD, Lecturer of anesthesia and surgical intensive care

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: February 5, 2016
• First Submitted That Met QC Criteria: February 22, 2016
• First Posted (Estimate): February 26, 2016

Study Record Updates

• Last Update Posted (Estimate): February 26, 2016
• Last Update Submitted That Met QC Criteria: February 22, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: R,∕ 15.07.07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED