Effect of Patient Position on Computerized Tomography Guided Celiac Trunk Neurolysis

Upper Abdominal Malignancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02692456
• Other study ID #: R,/ 15.07.07
• Status: Completed
• Phase: N/A
• First received: February 5, 2016
• Last updated: February 22, 2016
• Start date: June 2015
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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

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and tip were confirmed, the stylet was removed and aspiration was performed to ensure that there was no blood is withdrawn.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Neoplasms
• Upper Abdominal Malignancy

Intervention

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
• 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

Locations

Country	Name	City	State
Egypt	Mansoura University Cancer Institute	Mansoura	DK

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Failure rate of patients positioning	Positioning failure means failure to put patient in prone or lateral position	For 5 min before needle insertion	Yes
Secondary	Time to achieve analgesia	Time to achieve pain score less than 3	for one hour after performing the procedure	No
Secondary	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	No