Pain relieving effect of intra-operative chemical splanchnicectomy of celiac ganglions in patients with resectable pancreatic or gastric masses: a randomized clinical trial
The aim of this study is to evaluate the effect of intra-operative chemical splanchnicectomy on pain intensity during first fourth month after surgical resection of gastric and pancreatic masses. Approved diagnosis of resectable pancreatic or gastric neoplasms is the main inclusion criteria. Unresectable masses or history of neo-adjuvant chemotherapy are considered as main exclusion criteria. Sample size is calculated by use of Nomogram and comparison of two means equation. Eighty eight patients will be involved in this study, including 44 cases of gastric cancer and 44 cases of pancreatic cancer, each group will be divided into two subgroups by simple randomization after taking informed consent. For the case subgroups, 20 cc of 99.99% ethanol (of German Merk Company) which is diluted to 50% solution with normal saline will be injected to each of celiac ganglions at both sides of supra-pancreatic aorta. The control subgroups do not received any injection. This study is designed as a double-blinded clinical trial so neither reasearchers nor patients are not aware of injected solution. Before surgery, one, two and four days after surgery, discharge time, one month, two months and four months after surgery, researcher will ask patients to evaluate their pain intensity by the aid of Visual Analogue Scale (VAS) for pain. The result will be analyzed with latest version of SPSS.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015022821269N1
Registration date:2015-10-30, 1394/08/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-10-30, 1394/08/08
Registrant information
Name
Amir Saraee
Name of organization / entity
Firoozgar General Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 2286 4438
Email address
saraee.a@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
This article has registered as a thesis and is financially supported by Gastrointestinal Research Center of Firouzgar General Hospital.
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Pain relieving effect of intra-operative chemical splanchnicectomy of celiac ganglions in patients with resectable pancreatic or gastric masses: a randomized clinical trial
Public title
Effect of intraoperative Ethanol injection to nerve ganglions on pain intensity after surgical resection of gastric and pancreatic masses
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Resectable pancreatic cancer or gastric cancer; Obtaining informed consent for probable alcohol injection during surgery.
Exclusion criteria: Unresectable pancreatic cancer; Unresectable gastric cancer; Patients those who underwent neo-adjuvant chemotherapy; Patients who dissatisfaction with the procedures; Patients who expires before 4 month after operation; Prolonged post-operation hospitalization (more than 15 days) due to surgical complications; Age less than 15 or more than 80 year; History of prolonged consumption of opioids, NSAIDS, analgesic and anti-depressant drugs; Cardiac or pulmonary diseases; Sensitivity to opioid drugs; Psychological disorders; Abnormal arterial blood gas analysis; Happening of surgical complications or any other signs that results in disability to complete pain scale questionnaire (such as loss of consciousness).
Age
From 15 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway.
City
Tehran
Postal code
1449614535
Approval date
2015-04-14, 1394/01/25
Ethics committee reference number
IR.IUMS.REC.1394 24479
Health conditions studied
1
Description of health condition studied
Pain intensity after gastric or pancreatic neoplasm resection
ICD-10 code
R10.1
ICD-10 code description
Pain localized to upper abdomen
2
Description of health condition studied
Resectable malignant neoplasm of head of pancreas
ICD-10 code
C25.0
ICD-10 code description
Malignant neoplasm of head of pancreas
3
Description of health condition studied
Resectable malignant neoplasm of stomach
ICD-10 code
C16
ICD-10 code description
Malignant neoplasm of stomach
Primary outcomes
1
Description
Severity of abdominal pain
Timepoint
Before surgery, one, two and four days after surgery, discharge time, one, two and four months after surgery
Method of measurement
Visual Analogue Scale (VAS) questionnaire
Secondary outcomes
1
Description
Hospitalization time
Timepoint
Discharge time
Method of measurement
Number of days that patient stays at hospital after surgery
2
Description
Gastroparesia
Timepoint
Along first 72 hours after surgery
Method of measurement
Nausea, vomiting and volume of nasogastric tube secretions
3
Description
Arrhythmia or bradycardia
Timepoint
Along 72 hours after surgery
Method of measurement
Electrocardiography and cardiac monitoring
4
Description
Blood pressure
Timepoint
Every 30 minutes along 72 hours after operation
Method of measurement
Systolic and diastolic blood pressure will be measured by stethoscope and aneroid sphygmomanometer
Intervention groups
1
Description
no injection into control group during operation
Category
Placebo
2
Description
Injection of 20cc of prepared ethanol solution to each of celiac ganglions at both sides of supra-pancreatic portion of aorta.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Firouzgar General Hospital
Full name of responsible person
Amir Saraee
Street address
General Surgery Ward, Firouzgar General Hospital, Behafarin Ave. Valiasr Sq.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Masoudreza Sohrabi
Street address
Iran University of Medical Sciences, Shahid Hemmat Expressway.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Iran University of Medical Sciences
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
Firouzgar General Hospital
Full name of responsible person
Amir Saraee
Position
Assistant of General Surgery
Other areas of specialty/work
Street address
General Surgery Ward, Firouzgar General Hospital, Behafarin Avenue, Valiasr Square
City
Tehran
Postal code
Phone
+98 21 2286 4438
Fax
Email
Dr.a.saraee@gmail.com; Saraee.a@tak.iums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Firouzgar General Hospital
Full name of responsible person
Jalal Vahedian
Position
Professor of General Surgery
Other areas of specialty/work
Street address
General Surgery Ward, Firouzgar General Hospital, Behafarin Avenue, Valiasr Square
City
Tehran
Postal code
Phone
+98 22 8214 1377
Fax
Email
Jalvahedian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Firouzgar General Hospital
Full name of responsible person
Amir Saraee
Position
General Surgery assistant
Other areas of specialty/work
Street address
General Surgery Ward, Firouzgar General Hospital, Behafarin Ave. Valiasr Sq.
City
Tehran
Postal code
Phone
+98 21 2286 4438
Fax
Email
Dr.a.saraee@gmail.com; Saraee.a@tak.iums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)