The effect of rupivacaine diluted in dilating fluid on pain after hysteroscopic surgery
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 60 patients, used the random function of Excel software rand for randomization.
Settings and conduct
The study is double-blind. It will be performed at the Endometriosis Research Center of Iran University of Medical Sciences, Hazrat Rasool Akram Hospital. In the intervention group, diluted pivocaine (10 cc of half-percent ropivacaine per 1000 cc of normal saline per liter) will be given as a dilating fluid during hysteroscopy. The control group consisted of 30 patients will receive 10 cc of normal saline per 1000 cc of normal saline per liter as a dilating fluid during hysteroscopy.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Women candidates for hysteroscopy treatment based on the opinion of a specialist;
Conscious consent to participate in the study.
Exclusion criteria:
Presence of pelvic inflammatory disease, malignancy, drug sensitivity, neurological disorders, tube obstruction, pelvic pain
Intervention groups
Dilute ropivacaine (10 cc of half a percent ropivacaine per 1000 cc of normal saline per liter) is given as a dilating fluid during hysteroscopy
Main outcome variables
Intensity and frequency of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160527028109N4
Registration date:2021-05-11, 1400/02/21
Registration timing:registered_while_recruiting
Last update:2021-05-11, 1400/02/21
Update count:0
Registration date
2021-05-11, 1400/02/21
Registrant information
Name
Kobra Tahermanesh
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2562
Email address
tahermanesh.k@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-09-21, 1400/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of diluted ropivacaine in uterine distending fluid on pain after hysteroscopy surgeries
Public title
The effect of diluted ropivacaine in uterine distending fluid on pain after hysteroscopy surgeries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women candidates for hysteroscopy treatment based on the opinion of a specialist
Conscious consent to participate in the study
Exclusion criteria:
Existence of pelvic inflammatory disease
Having known cervical malignancy, severe uterine bleeding, cervical conization
Need for intraoperative surgery due to complications (such as laparotomy due to uterine perforation)
Having psychological or neurological disorders that affect pain perception.
Allergy to rupivacaine
Reluctance to continue cooperation while studying
Patients with chronic diseases with pain such as low back pain, etc. who use continuous painkillers.
Patients have previously had a tubectomy or have a bilateral obstruction of the tube.
Patients with preoperative pelvic pain, dyspareunia, dysmenorrhea, with a vas score of 3 or higher.
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study with a sample size of 60 people, 30 balls for intervention group A and 30 balls for intervention group B are placed inside a lottery container and then the balls are randomly removed from the container without replacement, so a sequence is created.
Blinding (investigator's opinion)
Double blinded
Blinding description
The outcome assessor and data analyst will not know how the groups are assigned. We divide patients into two groups, A and B, and the outcome assessor and data analyzer identify the patient with A and B and do not know the nature of the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University Of Medical Sciences
Street address
Sattar Khan - Hazrat Rasool Akram Hospital
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2021-04-20, 1400/01/31
Ethics committee reference number
IR.IUMS.REC.1400.102
Health conditions studied
1
Description of health condition studied
Pain after hysteroscopic surgery in gynecological diseases
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Intensity and frequency of pain
Timepoint
6, 12, 24 and 48 hours after hysteroscopy
Method of measurement
Questionnaire and patient file
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Dilute rupivacaine (10 cc of half a percent rupivacaine per 1000 cc of normal saline per liter) is given as a dilating fluid during hysteroscopy.
Category
Treatment - Drugs
2
Description
Control group: They receive 10 cc of normal saline per 1000 cc of normal saline per liter as a dilating fluid during hysteroscopy.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Rasool Akram Hospital
Full name of responsible person
Dr Kobra Tahermanesh
Street address
Sattar Khan - Hazrat Rasool Akram Hospital
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 6650 9283
Email
tahermanesh.k@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Seyed Abbas Motevalian-Vice President for Research of Iran University of Medical Sciences
Street address
Sattar Khan - Hazrat Rasool Akram Hospital
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 6650 9283
Email
tahermanesh.k@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?