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Assessment of duloxetine effect on post-operative pain and recovery in patients who undergo abdominal hysterectomy under general anesthesia

Protocol summary

Study aim
the main objective of this study is evaluating the effect of duloxetine on post-operative pain in abdominal hysterectomy.
Design
This is a randomised double blind clinical trial (phase 2-3) with blinded postoperative care and outcome assessment. The number of subjects is 70. The subjects are divided in 2 groups randomly using table of random numbers.
Settings and conduct
This study is performed on patients with hysterectomy surgery in Afzalipoor Hospital of Kerman. The person who perform the intervention is a nurse out of this study which gives the patients drug or placebo, so anesthesiologist, the patient and data collector and analyzer are unaware of used drug.
Participants/Inclusion and exclusion criteria
This study is a clinical trial on patients who are admitted in Afzalipoor Hospital of Kerman for hysterectomy which are given consent to participation. Exclusion criteria are long term usage of opioids a analgesics, taking steroids, age less than 18 and higher than 85, pregnancy, history of heart, hepatic and renal failure, uncontrolled hypertension, endocrine disorders, BMI more than 40.
Intervention groups
Patients in case group receive oral duloxedine 60 mg, 2 hours prior to surgery and patients in control group receive placebo. Anesthesia technique and medication in both groups are identical.
Main outcome variables
In all cases, vital signs, complications of duloxetine and amount of analgesics given to patient are checked prior to anesthesia; just after commence of surgery; at the time of giving isoflurane; during surgery and after operation and recovery time, every 15 minutes. The intensity of pain after anesthesia until discharge from recovery is determined and recorded. evaluation of pain in recovery is performed by means of Visual Analogue Scale (VAS). Patients discharged from recovery If they have scores of 9 or 10 according to aldrete scoring system. The amount of given analgesics in 24 hours is measured and overall patient satisfaction is assessed according to postoperative quality of recovery (QOR) score.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120922010900N5
Registration date: 2018-02-13, 1396/11/24
Registration timing: prospective

Last update: 2018-02-13, 1396/11/24
Update count: 0
Registration date
2018-02-13, 1396/11/24
Registrant information
Name
Hosein Sattari
Name of organization / entity
kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1322 2250
Email address
sattari@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of duloxetine effect on post-operative pain and recovery in patients who undergo abdominal hysterectomy under general anesthesia
Public title
Assessment of duloxetine effect on post-operative pain and recovery in patients who undergo abdominal hysterectomy under general anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients admitted to Afzalipoor Hospital for hysterectomy surgery ASA classification of I (without systemic disease) and II (with controlled systemic disease) informed consent of patient for participation
Exclusion criteria:
long term usage of opioids steroid thrapy age less than 18 and more than 85 year pregnancy heart, hepatic and renal failure uncontrolled hypertension endocrine diseases BMI greater than 40 heart rate less than 50 evidence of heart block in ECG presence of suizure, epilepsy and bipolar disorders surgery lasting more than 3 hours huge bleeding during surgery
Age
From 18 years old to 85 years old
Gender
Female
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Data analyser
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
the simple randomization is used to dividing the patients in 2 groups by means of table of random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
two hours before surgery, oral capsule of duloxetine is given to patients in case group and placebo (similar capsule containing starch) in control group. so, anesthesiologist, the patient and data collector are unaware of the kind of used drug.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical sciences
Street address
Jomhoori boulevard
City
Kerman
Province
Kerman
Postal code
7619813159
Approval date
2017-12-18, 1396/09/27
Ethics committee reference number
IR.KMU.REC.1396.1917

Health conditions studied

1

Description of health condition studied
postoperative pain
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain

Primary outcomes

1

Description
postoperative pain
Timepoint
The level of pain is measured and documented every 15 minutes after patient reorientation, until discharge from recovery room.
Method of measurement
Visual Analogue Scale (VAS) is used for pain assessment

Secondary outcomes

1

Description
Patient satisfaction
Timepoint
24 hours after surgery
Method of measurement
postoperative quality of recovery (QOR) score

2

Description
vital signs
Timepoint
every 15 minutes
Method of measurement
authomathic monitoring system

Intervention groups

1

Description
Intervention group: two hours prior to surgery, patients in this group receive 60 mg oral capsule of duloxetine; brand name of Loxeta, made by Abidi pharmaceutical company.
Category
Treatment - Drugs

2

Description
Control group: in this group, patients receive placebo.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Afzalipoor Hospital
Full name of responsible person
Hossein Sattari
Street address
Imam Khomeini Highway
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 1322 2250
Email
sattari@kmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Hassani
Street address
Tahmasbabad Square, Ebnesina Street
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3223 5011
Email
f_hassani@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Fariba Mansoorinassab
Position
assistant of anesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Afzalipoor Hospital, Zendan Square
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3223 5011
Email
javakrd34@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Hosein Sattari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Afzalipoor Hospital, Imamkhomeiny Highway
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 1322 2250
Fax
+98 34 1322 2763
Email
sattari@kmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fariba Mansoorinassab
Position
assistant of anesthesia
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Afzalipoor Hospital
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 1322 2250
Fax
Email
javakrd34@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
postoperative pain patient satisfaction of recovery
When the data will become available and for how long
data will be available just after publication in journal.
To whom data/document is available
data will be available for people working in academic institutions.
Under which criteria data/document could be used
they can repeat statistical analysis.
From where data/document is obtainable
contact via email address of responsible person
What processes are involved for a request to access data/document
after confirming identity of requested person.
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