Protocol summary

Summary
The Objectives of this study is to evaluate the effect of Endosome and Apotel on postoperative pain in patients with upper limb fracture undergoing general anesthesia. This is a phase III, single center, double-blind, randomized clinical trial in which patients with upper limb fractures referred to the Gorgan 5 Azar Medical Education Center will participate. They will be assigned into two intervention and control groups (sample size=50) through block randomization. Major eligibility criteria include: aged over 15 years, anesthesia risk factors 1 and 2, upper limb fracture. Primary exclusion criteria include patients with uncontrolled diabetes, patients with ischemic heart disease and stroke. After the end of the surgery and in the recovery phase, both groups will receive Patient Controlled Analgesia (PCA). For the control group, the pain pump will contain 2 grams of Apotel, which will be diluted with 100 cc normal saline 0.9 %. For the intervention group, the pain pump will contain 2 grams of Apotel and 8 milligrams of Ondansetron, which will be diluted with 100 cc normal saline 0.9 % and will be delivered at the rate of 4 cc / hr. The pain relief will be evaluated for 24 hours. The main outcome measure in this study will be pain and the main influencing variables will be the type of treatment group (intervention group, control group), gender, age, and smoking.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017062133566N1
Registration date: 2017-08-19, 1396/05/28
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-08-19, 1396/05/28
Registrant information
Name
Fatemeh Mehravar
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 893 7199
Email address
f.mehravar@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Golestan University of Medical Sciences
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of the effect of Ondansetron and Apotel on postoperative pain control in patients with upper limb fracture undergoing general anesthesia
Public title
The effect of Ondansetron in combination with Apotel in pain control
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ASA Class 1; Upper limb fracture; Patients who undergo anesthesia with propofol as an anesthetic inducer; Satisfied to participate in the study; being at the age of 15 and older. Exclusion criteria: ASA grade 3 and 4; uncontrolled diabetes; history of ischemic heart disease (IHD); history of stroke; malignancy; psychiatric problems; Pregnancy; surgery duration greater than 120 minutes; history of substance abuse or drug abuse; Alcohol consumption; history of liver problems; history of Apotel (acetaminophen) sensitivity; history of nausea and vomiting after previous surgical procedure; Patients with long Q-T intervals.
Age
From 15 years old to 90 years old
Gender
Both
Phase
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
Participants in the study by Block Randomization method will be allocated to intervention and control groups.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Golestan University of Medical Sciences.
Street address
Vice chancellor for research, Golestan University of Medical Sciences, Shast kolah Avenue
City
Gorgan
Postal code
49177-61551
Approval date
2017-07-23, 1396/05/01
Ethics committee reference number
IR.GOUMS.REC.1396.127

Health conditions studied

1

Description of health condition studied
Patients with upper limb fractures.
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
pain
Timepoint
24 hours and 48 hours after recovery.
Method of measurement
Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: the pain pump will contain 2 grams of Apotel and 8 milligrams of Ondansetron, which will be diluted with 100 cc normal saline 0.9 % and will be delivered at the rate of 4 cc / hr.
Category
Treatment - Drugs

2

Description
Control group:the pain pump will contain 2 grams of Apotel, which will be diluted with 100 cc normal saline 0.9 % and will be delivered at the rate of 4 cc / hr.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
5Azar Hospital
Full name of responsible person
Dr Salehe Akhoondi
Street address
Beside 5Azar Avenue, Azar 6th, 5Azar Hospital.
City
Gorgan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Golestan University of Medical Sciences
Full name of responsible person
Dr Mohsen Saeedi
Street address
Vice chancellor for research, Golestan University of Medical Sciences, Shast kolah Avenue
City
Gorgan
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, Golestan 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
Golestan University of Medical Sciences
Full name of responsible person
Dr Mohammadhosein Taziki
Position
MD, ENT
Other areas of specialty/work
Street address
Vice chancellor for research, Golestan University of Medical Sciences, Shast kolah Avenue
City
Gorgan
Postal code
Phone
+98 17 3242 1660
Fax
Email
dr.taziki@goums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Golestan University of Medical Sciences.
Full name of responsible person
Dr Seyed Babak Mojaver Aghili
Position
M.D
Other areas of specialty/work
Street address
5 Azar Hospital, next to Azar sheshom, 5 Azar Avenue, Gorgan
City
Gorgan
Postal code
Phone
+98 17 3235 4936
Fax
Email
salehe_akhoondi@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Fatemeh Mehravar
Position
Faculty Member
Other areas of specialty/work
Street address
Vice chancellor for research, Golestan University of Medical Sciences, Shast kolah Avenue
City
Gorgan
Postal code
Phone
+98 17 3235 4936
Fax
Email
mehravar10261@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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