Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201803003212106 Date of Registration: 18/03/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ultrasound Guided Celiac Plexus Neurolysis
Official scientific title Comparison Between Two Volumes Of 70% Alcohol In Single Injection Ultrasound Guided Celiac Plexus Neurolysis
Brief summary describing the background and objectives of the trial Patients with inoperable upper abdominal malignancies can be managed with medical treatment and interventional methods like celiac plexus neurolysis which can help improving the response to the medical treatment.The celiac plexus is a part of the autonomic nervous system that transmits pain from most of the upper abdominal organs. it is located in the retroperitoneal space around the celiac and mesenteric arteries between the 12th thoracic and the 2nd lumbar vertebrae.approaches to block the celiac plexus include Posterior approach in which two needles are inserted one on each side at the level of the first lumbar vertebra with fluoroscopic guidance. These are associated with many complications like paraplegia and serious neurological complications.Ultrasound guided anterior approach gives the operator and the patient many advantages including the ability to identify the true location of the celiac plexus even if it was displaced due to the mass effect. also, the use of the supine position is much more comfortable for the patient,and more importantly the prevention of the neurological and radiation risks.The use of alcohol for neurolysis is evidenced by many studies, however the data regarding the volume of alcohol injected is not consistent.The destructive effect of the alcohol is not limited to the celiac plexus nervous tissue alone, but rather it affects all the soft tissues encountered by the injected volume . Balancing between the neurolytic effect and the destructive effect is the rule of the volume of alcohol used. 1ry objective:To compare the pain relief effect of ultrasound guided percutaneous celiac plexus neurolysis using 20 ml versus 40 ml of 70% alcohol regarding visual analogue scale scores Secondary objectives:1-To compare the total daily opioid consumption between the two study groups for 12 weeks. 2-To compare quality of life using the general functional assessment of cancer therapy scale (FACT-G) between the two groups .
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/04/2018
Actual trial start date
Anticipated date of last follow up 01/10/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 32
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a randomisation table from a statistics book Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group I (CPN 20) 20 mls of 70 %alchohol ,once single injection after fasting for 6 hrs, IV accsess insertion, and doing succssful diagnostic block with bupivacaine ,20 mls of 70 % alchohol will be injected at the point between celiac and superior mesenteric arteries above the aortic wall. 16
Control Group Group II (CPN 40) 40 mls of 70 %alchohol ,once single injection after fasting for 6 hrs, IV accsess insertion, and doing succssful diagnostic block with bupivacaine ,40 mls of 70 % alchohol will be injected at the point between celiac and superior mesenteric arteries above the aortic wall. 16 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.Adult patients of either sex 18 years or older. 2.Patients with the diagnosis of histologically proven or radiologically consistent, surgically unresectable upper abdominal malignancies (including gastric, pancreatic, biliary system). 3.Patients with visual analogue scale (VAS) scores of equal to or more than 4/10 due to cancer related visceral pain in spite of adequate medical management (defined as the highest analgesia possible without intolerable side effects using opioid and non-opioid drugs according to the world health organization analgesic step ladder). 1.Refusal of participation in the study. 2.Patients received celiac or splanchnic blocks previously as a neurolytic management for cancer pain or those who did not respond to the diagnostic anesthetic block. 3.Patients received intrathecal or epidural interventional implantable devices for cancer pain. 4.Patients allergic to local anesthetics used in the diagnostic block. 5.Patients with coagulopathies not correctable with active medical management. 6.Patients with uncontrolled hypotension. 7.Patients suffering from pain not related to the abdominal malignancy such as neuropathic pain or central pain conditions. 8.Patients with documented metastatic lesions in other sites of the body contributing to pain severity. 9.Patients with psychiatric disorders preventing adequate assessment and data collection. 18 Year(s) 70 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/01/2018 research ethics committee ,faculty of medicine ,suez canal university
Ethics Committee Address
Street address City Postal code Country
kilo 4.5,ring road ismailia 41522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome visual analogue scale scores -baseline (before intervention) -20 mins after diagnostic block. -1 hour after the internention(alchohol injection). -24 hours after the intervention. -every week for 12 successive weeks after the intervention.
Secondary Outcome total daily opioid consumption -base line (before intervention). -24 hours after the intervention. -every week for 12 successive weeks after the intervention.
Secondary Outcome quality of life using the general functional assessment of cancer therapy scale (FACT-G) -base line (before intervention). -24 hours after the intervention. -every week for 12 successive weeks after the intervention
Secondary Outcome heamodynamics:heart rate , systolic blood pressure , diastolic blood pressure , mean arterial pressures and pulse oximetry saturation -base line (before intervention). -every 3 minutes during the procedure. -every 2 hours over the next 24 hours
Secondary Outcome Complications of the procedure including hypotension, diarrhea, hematoma, infection, procedure related pain, neurologic complications, and mortality -over the first 24 hours after the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
suez canal university hospital kilo 4.5 , ring road ismailia 41522 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
no funding sources
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor suez canal university hospital kilo 4.5 , ring road ismailia 41522 Egypt Hospital
Primary Sponsor anaethesia dapartement ,faculty of medicine ,suez canal university kilo 4.5 , ring road ismailia 41522 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mostafa Mahmoud Ebrahim eleshrini street ismailia 41511 Egypt
Mohamed Emad El-Din Abdel-Ghaffar eleshrini street ismailia 41511 Egypt
Salah Abdel-Fattah Mohamed Ismail eleshrini street ismailia 41511 Egypt
Reda Abo Al-Magd Ismail eleshrini street ismailia 41511 Egypt
Mohamed Elsayed Ibrahim Abdel-Hamid ard elgameiat ismailia 41511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mostafa Ebrahim m.mahmoud.scuh@gmail.com 002-01098984116 aleshrini street
City Postal code Country Position/Affiliation
ismailia 41511 Egypt assisstant lecturer of anesthesia
Role Name Email Phone Street address
Public Enquiries Reda Ismail dr.rowda@yahoo.com 002-01224997298 eleshrini street
City Postal code Country Position/Affiliation
ismailia 41511 Egypt lecturer of anesthesia and intensive care
Role Name Email Phone Street address
Scientific Enquiries mohamed abuelnaga Mohamed_abuelnga@med.suez.edu.eg 002-01004150671 ard elgameiat
City Postal code Country Position/Affiliation
ismailia 41511 Egypt lecturer of anesthesia and intensive care
Role Name Email Phone Street address
Scientific Enquiries Mohamed Abdel-Ghaffar Mohamed_abdelghafa@med.suez.edu.eg 002-01003179831 eleshrini street
City Postal code Country Position/Affiliation
ismailia 41511 Egypt professor of anesthesia and intensive care
Role Name Email Phone Street address
Scientific Enquiries Salah Ismail salahsenna@hotmail.com 002-01001573722 eleshrini street
City Postal code Country Position/Affiliation
ismailia 41511 Egypt professor of anesthesia and intensive care
REPORTING
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