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Trial registered on ANZCTR


Registration number
ACTRN12614000410651
Ethics application status
Approved
Date submitted
3/04/2014
Date registered
15/04/2014
Date last updated
27/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Analgesic efficacy of combined celiac and splanchnic nerve blocks in upper gastrointestinal tumours; A preliminary study
Scientific title
Effect of neurolytic celiac block or splanchnic block versus combined splanchnic and celiac blocks with 70% alcohol in patients with upper gastrointestinal tumours on analgesic requirements, postprocedural pain and quality of life
Secondary ID [1] 284391 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients suffer from visceral pain originating from in-operable abdominal cancer which originated from the upper abdominal viscera 291564 0
Condition category
Condition code
Anaesthesiology 291942 291942 0 0
Pain management
Cancer 291943 291943 0 0
Biliary tree (gall bladder and bile duct)
Cancer 291944 291944 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group III: for whom splanchnic using (10 ml of 70% alcohol preceded by 2 ml of 2% lidocaine will be injected in each needle, two needles will be used) and celiac blocks (with 20 ml of 70% alcohol preceded by 2.5 ml of 2% lidocaine will be injected in each needle, two needles will be used or 40 ml of alcohol in single needle approach )after failure of pain control with strong opioid medications and then, analgesic requirements will be managed according to severity of pain and WHO analgesic ladder..
The intervention wil be performed once for each patient.
Follow up will be extended along patients’ survival.
Intervention code [1] 289165 0
Treatment: Drugs
Comparator / control treatment
Group I: for whom celiac block will be performed (with 20 ml of 70% alcohol preceded by 2.5 ml of 2% lidocaine will be injected in each needle, two needles will be used or 40 ml of alcohol in single needle approach )after failure of pain control with strong opioid medications and then, analgesic requirements will be managed according to severity of pain and WHO analgesic ladder.
The intervention wil be performed once for each patient.
Follow up will be extended along patients’ survival.

Group II: for whom splanchnic block using (10 ml of 70% alcohol preceded by 2 ml of 2% lidocaine will be injected in each needle, two needles will be used) will be performed after failure of pain control with strong opioid medications and then, analgesic requirements will be managed according to severity of pain and WHO analgesic ladder.
The intervention wil be performed once for each patient.
Follow up will be extended along patients’ survival.
Control group
Active

Outcomes
Primary outcome [1] 291849 0
Pain intensity was evaluated by visual analogue scale 0 – 10 (where 0 means no pain and 10 means the worst possible pain).
Timepoint [1] 291849 0
At first visit (pre-enrollment), then every 2 weeks for one month and then monthly till patients' death.
Primary outcome [2] 291850 0
Consumption of analgesics will be assessed by revision of participant medical records.
Timepoint [2] 291850 0
At first visit (pre-enrollment), then every 2 weeks for one month and then monthly till patients' death
Secondary outcome [1] 307657 0
Patient satisfaction will be assessed by using quality of life Questionnaire (QLQ- C30),
Timepoint [1] 307657 0
At first visit (pre-enrollment), then every 2 weeks for one month and then monthly till patients' death
Secondary outcome [2] 307658 0
Opioids side effects, including loss of appetite, nausea or vomiting, insomnia, constipation, urinary retention, pruritis will be evaluated. A score of 0–3 for each symptom (0, no symptom; 1, mild whereas no treatment was required; 2, moderate; 3, severe and intolerable) will be determined by each patient.
Timepoint [2] 307658 0
At first visit (pre-enrollment), then every 2 weeks for one month and then monthly till patients' death

Eligibility
Key inclusion criteria
Patients suffer from visceral pain originating from in-operable abdominal cancer (originated from the upper abdominal viscera, from the stomach to the proximal transverse colon) reporting VAS equal to or greater than 7 after failure of strong opioids analgesics (3rd step of WHO analgesic ladder
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients have INR >1.5 or platelet count <50,000,infection at the site of needle entry, persistent hypotension, ascites or whom receive previous neurolytic block or have psychiatric illness or whom declines to participate will be excluded from the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A blinded pain physician who will determine if a subject is eligible for inclusion in the trial
Allocation will be concealed by
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Comparison of opioids consumption, pain intensity and QLQ-C30 scores will be made using the Student t test. Chi-square test will be used for comparison between reported side effects, number of patients used opioids between groups. Cumulative survival will be estimated using the Kaplan-Meier method with Log- Rank. Signifcance will be considered if P<0.05. All analyses will be performed using an intention-to-treat approach based on initial randomization by compensation missing data due patients' death in calculation by the last reported data value.
This study is a preliminary study, not powered and sample size determination based on previous clinical studies which had enrolled lesser number (1,2) of patients than 20 patients.
1-Arai YC, Nishihara M, Kobayashi K, Kanazawa T, Hayashi N, Tohyama Y, Nishida K, Arakawa M, Suzuki C, Kinoshita A, Kondo M, Matsubara S, Yokoe N, Hayashi R, Ohta A, Sato J, Ushida T. Neurolytic celiac plexus block reduces occurrence and duration of terminal delirium in patients with pancreatic cancer. J Anesth. 2013;27 :88-92

2- Julia K. LeBlanc, Susan Rawl, Michelle Juan, et al., “Endoscopic Ultrasound-Guided Celiac Plexus Neurolysis in Pancreatic Cancer: A Prospective Pilot Study of Safety Using 10 mL versus 20 mL Alcohol,” Diagnostic and Therapeutic Endoscopy, vol. 2013, Article ID 327036, 6 pages, 2013. doi:10.1155/2013/327036.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/05/2014
Actual
5/05/2014
Date of last participant enrolment
Anticipated
Actual
3/01/2016
Date of last data collection
Anticipated
Actual
5/02/2017
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 5960 0
Egypt
State/province [1] 5960 0
Mansoura
Country [2] 5973 0
Egypt
State/province [2] 5973 0
Gharbia

Funding & Sponsors
Funding source category [1] 289033 0
Self funded/Unfunded
Name [1] 289033 0
Country [1] 289033 0
Primary sponsor type
Individual
Name
Mohamed Y. Makharita
Address
Departments of Anesthesiology and Surgical Intensive Care, Faculty Of Medicine. El Mansoura University. 60 El Gomhoureya St. El Mansoura, El Dakahleya Post code: 35516.
Country
Egypt
Secondary sponsor category [1] 287705 0
Individual
Name [1] 287705 0
Yasser M. amr
Address [1] 287705 0
Departments of Anesthesiology and Surgical Intensive Care, Faculty of Medicine, Tanta University. El-Geish street, Tanta. 31527.
Country [1] 287705 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290834 0
medical research ethical committe- Mansoura university
Ethics committee address [1] 290834 0
Ethics committee country [1] 290834 0
Egypt
Date submitted for ethics approval [1] 290834 0
24/02/2014
Approval date [1] 290834 0
24/03/2014
Ethics approval number [1] 290834 0
R/83

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47502 0
A/Prof Mohamed Y. Makharita
Address 47502 0
Faculty Of Medicine - El Mansoura University - 60 El Gomhoureya St.
El Mansoura, El Dakahleya
Post code 35516
Country 47502 0
Egypt
Phone 47502 0
+20507929966
Fax 47502 0
Email 47502 0
[email protected]
Contact person for public queries
Name 47503 0
Yasser M. amr
Address 47503 0
Departments of Anesthesiology and Surgical Intensive Care, Faculty of Medicine, Tanta University. El-Geish street, Tanta. 31527.





Country: Egypt
Country 47503 0
Egypt
Phone 47503 0
+201224462887
Fax 47503 0
Email 47503 0
[email protected]
Contact person for scientific queries
Name 47504 0
Yasser M. amr
Address 47504 0
Departments of Anesthesiology and Surgical Intensive Care, Faculty of Medicine, Tanta University. El-Geish street, Tanta. 31527.



Country: Egypt
Country 47504 0
Egypt
Phone 47504 0
+201224462887
Fax 47504 0
Email 47504 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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