Investigation of intraperitoneal dexamethasone administration on reducing the severity of pain and reducing the frequency of drug administration after gynecological laparoscopic surgery
Design
A clinical trial with a control group, with parallel, two-way, blind, randomized groups, was performed on 70 patients who were divided into two equal groups of drugs and placebo according to the table of random numbers
Settings and conduct
Candidates for laparoscopic gynecological surgery at Shahid Sadoughi Hospital, entered the study in two groups. Patients were divided into two equal groups of drugs and placebo using a table of random numbers. In the first group, 20 cc of normal saline was injected, and in the second group, 20 cc of normal saline containing 16 mg dexamethasone was injected into the peritoneal cavity. Postoperative pain information was recorded in a questionnaire using the VAS criterion.
Participants/Inclusion and exclusion criteria
70 patients with ASA class 1 and 2; aged 18-70 candidates for gynecological laparoscopic surgery for myomectomy;
BMI is more than 30; diabetes or other underlying disease; abdominal surgery as well as a history of chronic; taking antinauseant drugs and vomiting 48 hours before surgery; long-term use of painkillers addiction; sensitivity to anesthetics and dexamethasone.
Intervention groups
Patients were divided into two equal groups using random number tables It should be noted that the drug and placebo were already prepared and coded in 20 cc syringes In the first group, after cesarean section and before leaving the trocar 20 cc of normal saline was sprayed in the diaphragm and peritoneal cavity In the second group after surgery and before leaving the trocar 20 cc of normal saline containing 16 mg dexamethasone was sprayed in the diaphragm and peritoneal cavity
Main outcome variables
Reduce pain and reduce the need for narcotics after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200424047191N1
Registration date:2020-06-18, 1399/03/29
Registration timing:retrospective
Last update:2020-06-18, 1399/03/29
Update count:0
Registration date
2020-06-18, 1399/03/29
Registrant information
Name
Fahimeh Dehghan Dehnavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3836 1465
Email address
fatemahdehghan@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-22, 1397/06/31
Expected recruitment end date
2019-03-19, 1397/12/28
Actual recruitment start date
2018-09-21, 1397/06/30
Actual recruitment end date
2019-03-18, 1397/12/27
Trial completion date
2019-03-18, 1397/12/27
Scientific title
"Investigation of the effect of intraperitoneal dexamethasone on pain after gynecological laparoscopic surgery"
Public title
"Investigation of the effect dexamethasone on pain after gynecological laparoscopic surgery"
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
70 female patients with ASA class 1 and 2
Age range of 18 to 70 years old
Candidates for elective surgery by gynecological laparoscopy to apply myomectomy in Shahid Sadoughi Hospital
Completing the written consent form
Exclusion criteria:
BMI over 30
Diabetes or other underlying disease
Abdominal surgery as well as a history of chronic pain
Taking anti nausea drugs and vomiting 48 hours before surgery is a long-term use of painkillers, addiction, sensitivity to anesthetics and dexamethasone.
Age
From 18 years old to 70 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Actual sample size reached:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were divided into two equal groups of drugs and placebo using the simple random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient and the person following the patient and filling out the questionnaire do not know any of the drugs used (dexamethasone or placebo)
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yazd University of Medical Sciences
Street address
Yazd-International Branch of Shahid Sadoughi University of Medical Sciences
City
Yazd
Province
Yazd
Postal code
8944158318
Approval date
2018-01-09, 1396/10/19
Ethics committee reference number
IR.SSU.MEDICINE.REC.1396.227
Health conditions studied
1
Description of health condition studied
Pain after myomectomy after laparoscopy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Dexamethasone side effects include: hyperglycemia, dizziness and headache and tinnitus
Timepoint
After surgery
Method of measurement
Questionnaire
2
Description
Shoulder pain after surgery The scoring system is based on the Visual Analogue Scale system so that we can explain to the patient that 0 means no pain and 10 means the most pain is tolerable.
Timepoint
After surgery
Method of measurement
Questionnaire
3
Description
Abdominal pain after surgery. The scoring system is based on the Visual Analogue Scale system so that we can explain to the patient that 0 means no pain and 10 means the most pain is tolerable.
Timepoint
After surgery
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, normal saline containing 16 mg of dexamethasone is sprayed into the diaphragm and peritoneal cavity after surgery and before leaving the trocar
Category
Treatment - Drugs
2
Description
Control group: After surgery and before leaving the trocar, 20 cc of normal saline is sprayed in the diaphragm and peritoneal cavity
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital
Full name of responsible person
Dr. Atiye Javaheri
Street address
Shahid Sadoughi HospitalYazd
City
Yazd
Province
Yazd
Postal code
8916886938
Phone
+98 35 3822 4000
Fax
+98 35 1822 4100
Email
atiyeh56@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzaei
Street address
Vice Chancellor for Research Sadoughi University of Medical Sciences, Yazd
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3724 0171
Email
masoud_mirzaei@hotmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Dr Atiye Javaheri
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shahid Sadoghi Hospital Yazd
City
Yazd
Province
Yazd
Postal code
8916886938
Phone
+98 35 3822 4000
Email
atiyeh56@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr Atiye Javaheri
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shahid Sadoghi Hospital Yazd
City
Yazd
Province
Yazd
Postal code
8916886938
Phone
00893538224000
Email
atiyeh56@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr Atiye Javaheri
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shahid Sadoghi Hospital Yazd
City
Yazd
Province
Yazd
Postal code
8916886938
Phone
+98 35 3822 4000
Email
fatemahdehghan@gmail.com
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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
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