1)Goals: The aim of this double-blinded RCT is to compare the effect of conventional and pulsed-RF Celiac ganglion neurolysis on relieving pain in patients with abdominal cancer in order to find the most effective method in relieving pain in this group of patients.
2) Designing the study: This neurolytic block would be performed in patients after being randomly allocated into 2 groups. After taking informed consent from all patients, the block would be performed under fluoroscopy; in the conventional group after placing the needle on correct position, continuous RF would be used for two cycles of 90seconds, and in the pulsed-RF group two cycles of pulsed radiofrequency for 15 minutes are used. The visual analogue score, and the amount of daily used analgesic would be measured weekly for 3 consecutive months.
3) Technique: The patients will be randomly divided into two groups of CRF and PRF. In the conventional RF group, two cycles of90 seconds and in the pulsed RF one, two cycles of 15 minutes would be used.
4) Follow up: After the procedure, the pain score according to VAS, and the amount of daily used analgesic are recorded in the questionnaire forms for 3 consecutive months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201306307984N9
Registration date:2013-09-11, 1392/06/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-09-11, 1392/06/20
Registrant information
Name
Farnad Imani
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6651 5758
Email address
farnadimani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Tehran university of medical sciences, Vice-chancellor for research
Expected recruitment start date
2012-05-08, 1391/02/19
Expected recruitment end date
2014-05-09, 1393/02/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Pulsed and Conventional Radiofrequency celiac plexus neurolysis on Abdominal Cancer Pain
Public title
Comparing the effect of Pulsed and Conventional Radiofrequency celiac plexus neurolysis on Abdominal Cancer Pain
Purpose
Treatment
Inclusion/Exclusion criteria
Iinclusion criteria: Age range of 20 to 60 years old ; painful non-operable abdominal cancer
Exclusion criteria: Renal failure; Pregnancy; Allergy to Ropivacaine and Opioid; Significant coexisting disease (CNS or cardiovascular problems)
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran university of medical sciences
Street address
Tehran University of Medical Sciences (TUMS), 4th floor, Corner Ghods St., Keshavarz Blv,Tehran
City
Tehran
Postal code
1417653761
Approval date
2012-05-06, 1391/02/17
Ethics committee reference number
90-01-30-13002-42105
Health conditions studied
1
Description of health condition studied
Abdominal cancers
ICD-10 code
C25.0
ICD-10 code description
Malignant neoplasm of pancreas
Primary outcomes
1
Description
Visual analogue score according to the designed pain ruler
Timepoint
Weekly for 3 consecutive months
Method of measurement
Visual analogue score is measured with a marked ladder from 0 to 10
2
Description
The amount of analgesic used
Timepoint
Weekly for 3 consecutive months
Method of measurement
The percentage of the used analgesic is measured by dividing the amount of analgesic after the block by the amount before the block and then multiplying the result by 100
Secondary outcomes
1
Description
Blood pressure changes
Timepoint
Before the intervention and 3 weeks thereafter
Method of measurement
Measured with digital sphygmomanometer
Intervention groups
1
Description
The patients are first divided into 2 groups each containing 25 persons. In the first group or the PRF group, celiac plexus block would be performed under fluoroscopy and sterile condition after placing the patient on prone position on the OR table. All the patients should have IV line and pulse-oxymetry plus blood pressure and ECG monitoring. The target point is on the anterolateral part of the first lumbar vertebrae. After prep and drape of the skin, a skin wheal would be made by injection of Lidocaine 2 %( 5 ml) into the subcutaneous tissues. The C-arm will be placed in 30 degrees ipsilateral oblique position and the 150 mm RF cannula with 10 mm active tip will be introduced in tunnel vision towards the L1 vertebral body. In the lateral view the needle tip should reach 1-2 centimeter in front of the L1 body. Then 2 ml contrast media (Visipaque 270 mg/dl) would confirm the correct position and 5 ml Ropivacaine 0.5 % ( long-acting local anesthetic) would be injected. Afterwards the Radiofrequency waves in the pulsed mode at 42 degrees and for two cycles of 15 minutes would be started with an interval of 30 seconds between the two.
Category
Treatment - Other
2
Description
In the second group the same method is used except for the final stage for which the conventional mode with RF cycles of 90 degrees and for 90 seconds will be used twice with an interval of 30 seconds. At the end of the procedure, the patients will be transferred to the recovery room and they will be discharged if no complication occurs after2 hours
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat e Rasoul Hospital
Full name of responsible person
Dr Farnad Imani
Street address
Department of anesthesiology and pain Rasoul-Akram Medical Center, 4th floor, number 7, Niyayesh St, Sattar Khan Av
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran university of medical sciences, Vice-chancellor for research
Full name of responsible person
Dr Akhounzadeh
Street address
The Vice-chancellor for research of TUMS, 4th floor, the central building of TUMS, Ghods St., Keshavarz Boulvard, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran university of medical sciences, Vice-chancellor for research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran university of medical sciences
Full name of responsible person
Dr Farnad Imani
Position
Associate professor
Other areas of specialty/work
Street address
Department of anesthesiology and pain Rsoul-Akram Medical Center,4th floor, number 7, Niyayesh St, Sattar Khan Av
City
Tehran
Postal code
1445613131
Phone
+98 21 6435 2107
Fax
Email
farimani@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Farnad Imani
Position
Associate professor
Other areas of specialty/work
Street address
Department of anesthesiology and pain Rsoul-Akram Medical Center,4th floor, number 7, Niyayesh St, Sattar Khan Av
City
Tehran
Postal code
1445613131
Phone
+98 21 6435 2107
Fax
Email
farimani@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Farnad Imani
Position
Associate professor
Other areas of specialty/work
Street address
Department of anesthesiology and pain Rsoul-Akram Medical Center, 4th floor, number 7, Niyayesh St, Sattar Khan Av
City
Tehran
Postal code
1445613131
Phone
+98 21 6435 2107
Fax
Email
farimani@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)