Clinical Trial Comparing The Effects Of Injection And Non-injection Transcervical Intrauterine Bupivacaine For The Management Of Postoperative Pain Following Uterine Curettage Under General Anesthesia
This study is a randomized double-blind clinical trial. The aim of this study is to assess the effect of transcervical intrauterine bupivacaine injection of postoperative pain following uterine curettage under general anesthesia in 70 patients with ages: 18-50 years old. The patients with heart disease and convulsion will be excluded. The patients are randomly divided into two groups. Anesthesia induction in two groups is identical with 2 mg of midazolam and 50 µg of fentanyl and 0.5 mg/kg of Propofol and ventilation with 50% nitrous oxide by face mask. First group receives 15 ml of bupivacaine (0.125 %) using a urinary catheter which is directly proportional to the size of the outlet of the cervix. After 15-20 minutes, the urinary catheter is extracted from the cervix cavity. Second group does not receive bupivacaine. The patients do not know that they have received bupivacaine or not and evaluation of patients is performed by anesthesiologist who does not know about the protocol of the study. The severity of pain in patients will be assessed with a visual analog scale after injection of bupivacaine. The patients will receive 100 mg diclofenac suppository If visual analog scale is more than three.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015010616119N3
Registration date:2015-01-30, 1393/11/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-01-30, 1393/11/10
Registrant information
Name
Reza Akhondzadeh
Name of organization / entity
Imam Khomeini Hospital
Country
Iran (Islamic Republic of)
Phone
+98 61 1221 6504
Email address
akhondzadeh-r@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jondishapour University of Medical Sciences
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Trial Comparing The Effects Of Injection And Non-injection Transcervical Intrauterine Bupivacaine For The Management Of Postoperative Pain Following Uterine Curettage Under General Anesthesia
Public title
The Effect of Bupivacaine in The Prevention of Postoperative Pain Curettage
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Woman undergoing curettage surgery. Exclusion Criteria: History of heart disease; Convulsion; Sensitivity to local anesthetic.
Age
From 18 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The table of random numbers used for randomization, A code will be assigned to each patient by a person who does not know about the protocol of the study.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jondishapour University Of Medical Sciences
Street address
Ground Floor, Central Library, Ahvaz Jondishapour University of Medical Sciences, Golestan BLvd., Ahvaz
City
Ahvaz
Postal code
Approval date
2015-03-01, 1393/12/10
Ethics committee reference number
Ajums.REC.1393.316
Health conditions studied
1
Description of health condition studied
pain
ICD-10 code
Y45
ICD-10 code description
Analgesics, antipyretics and anti-inflammatory drugs
Primary outcomes
1
Description
pain
Timepoint
1, 2, 3, 4, 8 and 12 hours after injection of bupivacaine
Method of measurement
visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
Group I: Transcervical intrauterine injection of 15 ml of bupivacaine (0.125 %) using a urinary catheter after anesthesia.
Category
Prevention
2
Description
Group II: Patients does not receive bupivacaine (Control group) .
Vice chancellor For Research Of Ahvaz Jondishapour University of Medical Sciences
Full name of responsible person
Nader Saki
Street address
Vice chancellor For Research Of Ahvaz Jondishapour University of Medical Sciences, Ground Floor, Central Library, Ahvaz Jondishapour University of Medical Sciences, Golestan BLvd., Ahvaz
City
Ahvaz
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 Of Ahvaz Jondishapour 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
Imam Khomeini Hospital
Full name of responsible person
Reza Akhondzadeh
Position
Anesthesiologist
Other areas of specialty/work
Street address
Department of Anesthesiology, General Operation room, Second Floor, Imam Khomeini Hospital, Shahid Ahvazian St., Ahvaz.
City
Ahvaz
Postal code
Phone
+98 61 3221 6504
Fax
Email
rezaakh@hotmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Imam Khomeini Hospital
Full name of responsible person
Reza Akhondzadeh
Position
Anesthesiologist
Other areas of specialty/work
Street address
Department of Anesthesiology, General Operating Room, Second Floor Of The Imam Khomeini Hospital, Sh
City
Ahvaz
Postal code
Phone
+98 61 3221 6504
Fax
Email
rezaakh@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Pain Research Center
Full name of responsible person
Sanaz Nazari
Position
Nurse Anesthesia
Other areas of specialty/work
Street address
Pain Research Center, Fourth Floor of Imam Khomeini Hospital, Shahid Ahvazian St., Ahvaz
City
Ahvaz
Postal code
6193673166
Phone
+98 61 3221 6504
Fax
Email
s.nz1990@yahoo.com; nazari_s@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)