The aim of this study was to determine the effect of mint extract on reducing the severity of postoperative pain in cholecystectomy
Design
This is a double-blind clinical trial carried out in Emdad hospital of Sabzevar City. This study conducted on a total of 107 patients (47 placebo and 60 drug patients), who were candidate for cholecystectomy. Drug and placebo (40 drops three times every 20 minutes) were administered to patients suffering from postoperative pain after the recovery or stimulation of the gag reflex and onset of pain. The effect of mint extract on pain intensity was evaluated using the visual analog scale
Settings and conduct
This is a double-blind clinical trial conducted in Emdad Hospital in Sabzevar city on 107 patients undergoing open cholecystectomy.
Participants/Inclusion and exclusion criteria
The personal satisfaction to participate in the study
Not having any mental or other illnesses
Intervention groups
Intervention group: 60 people are in the intervention group. Mint extract (40 drops three times every 20 minutes) was administered to patients suffering from postoperative pain after the recovery or stimulation of the gag reflex and onset of pain. The effect of mint extract on pain intensity was evaluated using the visual analog scale. Control group: 60 people are in the control group. Placebo (40 drops three times every 20 minutes) was administered to patients suffering from postoperative pain after the recovery or stimulation of the gag reflux and onset of pain. The pain intensity is evaluated using visual pain scale.
Main outcome variables
The severity and duration of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170404033202N8
Registration date:2018-01-12, 1396/10/22
Registration timing:prospective
Last update:2018-01-12, 1396/10/22
Update count:0
Registration date
2018-01-12, 1396/10/22
Registrant information
Name
Atefeh Asadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4422 9180
Email address
a.asadi.mm.1384@gmail.com
Recruitment status
Recruitment complete
Funding source
Investigation
Expected recruitment start date
2018-02-19, 1396/11/30
Expected recruitment end date
2018-05-21, 1397/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Peppermint Extract with Placebo on Reducing Postoperative Pain During Elective Cholecystectomy
Public title
Effect of mint extract on pain relief after elective cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Have personal consent
Weight between 40 and 120 kg
Age between 75 and 25 years
Elective surgery
Exclusion criteria:
Physical and mental illness
Use opioid or alcohol
History of surgery less than 3 years ago
Receive fentanyl more than 2 micrograms per kilogram body weight before surgery or antiemetic as a precursor.
Age
From 25 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
107
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients, researcher and analysist are not aware of the contents of the capsules.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Central Office of the University of Medical Sciences - Asadabadi Street
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617684155
Approval date
2017-09-23, 1396/07/01
Ethics committee reference number
IR.Medsab.Rec.1395.146
Health conditions studied
1
Description of health condition studied
Pain after elective cholecystectomy
ICD-10 code
K90-93
ICD-10 code description
K91.5 Postcholecystectomy syndrome
Primary outcomes
1
Description
Severity of pain
Timepoint
1 hour after the onset of the medication
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 60 people are in the intervention group. Mint extract (40 drops three times every 20 minutes) was administered to patients suffering from postoperative pain after the recovery or stimulation of the gag reflex and onset of pain. The effect of mint extract on pain intensity was evaluated using the visual analog scale.
Category
Treatment - Drugs
2
Description
Control group: 60 people are in the control group. Placebo (40 drops three times every 20 minutes) was administered to patients suffering from postoperative pain after the recovery or stimulation of the gag reflux and onset of pain. The pain intensity is evaluated using visual pain scale.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emdad Shahid Beheshti hospital in Sabzevar
Full name of responsible person
Mohammad Nematshahi
Street address
Emdad Shahid Beheshti hospital, Kooshk Street
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617684155
Phone
+98 51 4422 9180
Email
9157638703mn@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Fereshteh GHorat
Street address
Pardiss University, Koosar Street, Touhid Blvd
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617684155
Phone
+98 51 4401 1035
Email
ghorat.f@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Atefeh Asadi
Position
G.P.
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Department of Health, Talghani Street
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617684155
Phone
+98 51 4422 9180
Fax
Email
aa.9157638703@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mohammad Nematshahi
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Central building of the University, Asadabadi Street
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617684155
Phone
+98 51 4422 9180
Fax
Email
9151737407mn@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Atefeh Asadi
Position
G.P.
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Department of Health, Talghani Street
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617684155
Phone
+98 51 4422 9180
Fax
Email
9157638703mn@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available