Analyzing the effect of Zingiber Officinale on reduction of postoperative pain after hernia and hydrocele operation under general anesthesia in patients of the Shahrekord Kashani hospital surgery ward
The aim of this study is to assess the effect of Zingiber Officinale on incision site pain in patients going under hernia or hydrocele surgery under general anesthesia. First, 90 patients meeting inclusion criteria and lacking exclusion criteria will be selected. The main inclusion criteria are the age of 15 to 55 years, not taking ginger on regular bases and not being subject to substance abuse. The main exclusion criteria are taking corticosteroids or NSAID before the study, allergy to ginger, and surgery duration more than 45 minutes. Patients will then be divided randomly into two groups of intervention and control. The intervention group will receive 4 Zintoma capsules containing 250 mg of rhizome powder of Zingiber Officinale with 20 cc drinking water 2 hours prior to the surgery. The control group will receive 4 capsules containing starch powder with the same amount of water. All patients will go under general anesthesia with the same medications and all will receive 20 mg/kg Fentanyl as analgesic after surgery. The pain of the surgery incision will be assessed 30 minutes, 1,2, 6, and 24 hours after surgery using VAS scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017051533978N1
Registration date:2017-10-11, 1396/07/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-11, 1396/07/19
Registrant information
Name
Elham Lalegani
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 913 385 2536
Email address
st-lalegani.s@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
The research center of Shahrekord University of Medical Sciences
Expected recruitment start date
2017-05-15, 1396/02/25
Expected recruitment end date
2017-06-05, 1396/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Analyzing the effect of Zingiber Officinale on reduction of postoperative pain after hernia and hydrocele operation under general anesthesia in patients of the Shahrekord Kashani hospital surgery ward
Public title
Analyzing the effect of Zingiber Officinale on reduction of postoperative pain after hernia and hydrocele operation under general anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Elective hydrocele or hernia surgery; surgery duration less than 45 minutes; patients with ASA class I-III; not taking ginger on regular basis; not taking corticosteroids, no allergy to ginger; no allergy to NSAIDS or Acetaminophen; not taking anticoagulatory agents;
Exclusion criteria:
Surgury duration more than 45 minutes; change in the course of the surgery(complications e.g. bleeding or change of diagnosis e.g. malignancy); no tendency to participate; hematologic or gastrointestinal disorders; substance abuse; any type of fever, infection or disease post surgery.
Age
From 15 years old to 55 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
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 Shahrekord University of Medical Sciences
Street address
Shahrekord University of Medical Sciences, Kashani Blv.
City
Shahrekord
Postal code
Approval date
2017-05-03, 1396/02/13
Ethics committee reference number
IR.SKUMS.REC.1396.39
Health conditions studied
1
Description of health condition studied
Inguinal hernia
ICD-10 code
K40.9
ICD-10 code description
Unilateral or unspecified inguinal hernia, without obstruction or gangrene Inguinal hernia (unilateral) NOS
2
Description of health condition studied
Hydrocele
ICD-10 code
N43.3
ICD-10 code description
Hydrocele, unspecified
Primary outcomes
1
Description
Pain
Timepoint
30 minutes, 1, 2, 6 , and 24 hours after surgery
Method of measurement
VAS questionnaires
Secondary outcomes
empty
Intervention groups
1
Description
Zintoma capsule, 250 mg, Gol darou factory, 4 capsules 30 minutes before surgery
Category
Treatment - Drugs
2
Description
Starch powder capsule, 250 mg, 4 capsules 30 minutes before surgery
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani hospital of Shahrekord
Full name of responsible person
Street address
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research center of Shahrekord University of Medical Sciences
Full name of responsible person
Kamal Solati Phd
Street address
Shahrekord University of Medical Sciences, Kashani Blvd.
City
Shahrekord
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 center of Shahrekord 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
Shahrekord University of Medical Sciences
Full name of responsible person
Elham Lalegani
Position
Medical student
Other areas of specialty/work
Street address
Hajar hospital, Parastar st.
City
Shahrekord
Postal code
Phone
+98 38 3222 0016
Fax
Email
ST-lalegani.s@skums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Ebrahim Pouria Mofrad. MD
Position
Anesthesiologist
Other areas of specialty/work
Street address
Kashani hospital, Parastar st.
City
Shahrekord
Postal code
8168764181
Phone
+98 38 1222 0016
Fax
Email
EBRAHIM_POORYA@YAHOO.COM
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Elham Lalegani
Position
Medical student
Other areas of specialty/work
Street address
Hajar hospital, Parastar st.
City
Shahrekord
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)