Clinical trial NCT02692456: Effect of Patient Position on Computerized Tomography Guided Celiac Trunk Neurolysis
Official title: Efficacy of Patient Position After Computerized Tomography Guided Antero-crural Celiac Trunk Neurolysis on Upper Abdominal Malignancy Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Abdominal Malignancy
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2016-02-26
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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

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and tip were confirmed, the stylet was removed and aspiration was performed to ensure that there was no blood is withdrawn.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

Eligibility criteria: 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

Primary outcomes:
measure: Failure rate of patients positioning
timeFrame: For 5 min before needle insertion
Secondary outcomes:
measure: Time to achieve analgesia
timeFrame: for one hour after performing the procedure
measure: Failure of block
timeFrame: For 1 week after performing the procedure
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Cancer Institute
state: DK
Study officials:
affiliation: Lecturer of Anesthesia and Surgical Intensive Care
name: Alaa A Elmaadawy, MD
role: STUDY_DIRECTOR
affiliation: Professor of Anesthesia and Surgical Intensive Care
name: Ghada F EL-Rahmawy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: lecturer of Anesthesia and Surgical Intensive Care
name: Nevert A Abdelghaffar, MD
role: STUDY_CHAIR
References: