Effect of preoperative duloxetine administration on decreasing VAS score of women undergoing total abdominal hysterectomy post operatively compared to control group at Moheb Yas hospital in Tehran
Design
This study will be a double-blind randomized clinical trial and patient will randomly divided into control and duloxetine receiving groups,The sample size was 50 individuals based on analysis of variance of repeated measures, with 25 individuals in each group.
Settings and conduct
It's a double blind randomized clinical trial (patient and anesthesiologist Will be unaware of the type of medication received)it will
performed at Moheb Yas Hospital in Tehran,women's candidates for abdominal hysterectomy with inclusion criteria will divide randomly into two groups of duloxetine recipients 2 hours before surgery and the control group who will receive placebo.they undergo general anesthesia, and at the end of the operation, patients with a VAS score greater than 4 receive 2 mg morphine sulfate and then will record PONV and the first time they need the drug and the total amount of the drug received within the first 24 hours after surgery
Participants/Inclusion and exclusion criteria
All 30-60 year old women with ASA class 1-2 who underwent elective abdominal hysterectomy at Tehran Moheb Yas Hospital within the study time and are willing to participate in this study
Those who are allergic to the drug, or have a surgery longer than 3 hours, have a diagnosis of cancer after surgery or discover any other pelvic pathology in operation, need additional surgery, or any technique than pfannenstiel incision will excluded from the study
Intervention groups
Case who will receiving duloxetine 60 mg 2 hours before surgery and control group who will receiving placebo two hours before surgery
Main outcome variables
In need of analgesia,pain intensity, type of drug used, nausea, vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120624010102N2
Registration date:2019-12-10, 1398/09/19
Registration timing:prospective
Last update:2019-12-10, 1398/09/19
Update count:0
Registration date
2019-12-10, 1398/09/19
Registrant information
Name
Ehsan Bastan hagh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4204 6310
Email address
drbastanhagh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-20, 1398/10/30
Expected recruitment end date
2020-08-18, 1399/05/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Duloxetine administeration on postoperative pain after abdominal hysterectomy compared to the placebo
Public title
effect of duloxetine on post operative pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female age 35-65
Elective total abdominal hysterectomy
ASA class 1 & 2
Exclusion criteria:
patient refusal
Any alergic history with Duloxetine or other SNRIs
surgery longer than 3 hours
Postoperative cancer diagnosis or any other pelvic pathology during the operation
Need additional surgery
Any other incision than Pfannenstiel
Age
From 35 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly allocated to 2 groups using balanced block randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
The study medications are prepared by an anesthesiologist who does not otherwise participated in the study and then enveloped and sealed and patient's code are recorded on it.The enveloped will open 2 hours before induction by an anesthesiologist who is blinded to patient's study group and type of solution.All of the nurses and patient's are blinded to the type of solution and to the patient's study group allocation.