Determining the relationship between perineal nerve anesthesia and the level of analgesia after pelvic floor prolapse surgeries
Design
Clinical trial with a control group, with parallel groups, randomized single-blind, phase 2 on 25 patients. The rand function of Excel software was used for randomization.
Settings and conduct
In Imam khomeini hospital complex in Tehran, women ward in the intervention group, after the surgery, 2 cc of Marcaine 7.5 mg/ml and in the control group, the same volume of normal saline will be injected inside the vagina 1 cm lateral and behind the ischial spines. The day after the surgery, the visual Analogue scale (VAS) is used to compare the number of analgesics they asked for and the number of nausea feelings.
Due to the similarity of the method of intervention and control, the patient's side is blinded. The researcher who performs the analysis at the end is also unaware of the allocation of groups and therefore is blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: women aged 30-80 years undergoing various types of pelvic floor prolapse surgeries
Exclusion criteria: having concurrent abdominal or laparoscopic surgery
Intervention groups
The intervention includes investigating the effect and side effects of Marcaine as a pudendal nerve block in reducing pain and analgesic use after pelvic floor prolapse surgeries.
The control group includes the same people but under the injection of normal saline serum as a placebo with the same volume and in the same region of the pudendal block for comparison.
Main outcome variables
Postoperative pain using VAS scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231025059847N1
Registration date:2023-11-09, 1402/08/18
Registration timing:prospective
Last update:2023-11-09, 1402/08/18
Update count:0
Registration date
2023-11-09, 1402/08/18
Registrant information
Name
Hamideh Nematian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 0000
Email address
hnematian6173@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-11, 1402/08/20
Expected recruitment end date
2023-12-21, 1402/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the analgesia effect of perineal nerve blockage with marcaine with placebo after pelvic floor prolapse surgeries
Public title
Investigating the analgesia effect of pudendal block with placebo after pelvic floor prolapse surgeries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women undergoing pelvic floor prolapse surgery
Exclusion criteria:
History of chronic pelvic pain
History of hypersensitivity to blocking drugs, narcotics or analgesics
Chronic use of analgesics or narcotics
Patients suffering from liver or kidney problems
Patients with simultaneous abdominal or laparoscopic surgery
Age
From 30 years old to 80 years old
Gender
Female
Phase
2-3
Groups that have been masked
Data analyser
Sample size
Target sample size:
25
Randomization (investigator's opinion)
Randomized
Randomization description
This study has two arms. First arm: pudendal block with marcaine. The second arm is the control group with placebo.
In this study, random allocation will be done, the type of random allocation is block and the randomization unit is individual. Blocks of 4 will be used for random allocation. The randomization tool is the following online software:
https://www.sealedenvelope.com/simple-randomiser/v1/lists
Therefore, people will be randomly placed in one of two groups. In this study, due to the fact that the intervention is determined for the surgeon and the patient and is an open-label trial, blinding is not possible, but the analyzers of A and B will be blinded.
Concealment will be done in the study.
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding: the researcher who performs the analysis at the end is unaware of the allocation of the groups. So the study is one-side blind.
The patient side is not blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences, Imam Khomeini hospital complex
Checking the number of analgesics requests in the file
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Women undergoing pelvic floor prolapse surgery, 30-80 years old, for whom pudendal block is performed as follows: 2 cc of Marcaine 7.5 mg/ml aspen group of companies inside the vagina, 1 cm lateral and behind the ischial spines.
Category
Treatment - Drugs
2
Description
Control group: Women undergoing pelvic floor prolapse surgery, 30-80 years old, for whom normal saline is administered in the same way as pudendal block after surgery: 2 cc of normal saline 0.9% inside the vagina, 1 cm lateral and behind the ischial spines.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital complex
Full name of responsible person
Hamideh Nematian
Street address
Imam Khomeini hospital complex, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733134
Phone
+98 21 6119 0000
Email
hnematian6173@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Deputy of research and technology center of Tehran University of Medical Sciences
Street address
Tehran university of medical science, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6649 2271
Email
tums_edu@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Hamide Nematian
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamide Nematian
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam Khomeini hospital complex, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733134
Phone
+98 21 6119 0000
Email
hnematian6173@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Tahereh Eftekhar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam Khomeini hospital complex, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733134
Phone
+98 21 6119 0000
Email
eftkhart@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamide Nematian
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam Khomeini hospital complex, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733134
Phone
+98 21 6119 0000
Email
hnematian6173@gmail.com
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
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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
After unrecognizing the participants, patient's demographic data, study protocol and main outcome information will be shared.
When the data will become available and for how long
The access period starts 3 months after the results are published
To whom data/document is available
All doctors and researchers working in the field of obstetrics and gynecology
Under which criteria data/document could be used
Any data analysis and use of documents in the field of obstetrics and gynecology is allowed
From where data/document is obtainable
The email address of the project manager: Hamide Nematian
hnematian6173@gmail.com
What processes are involved for a request to access data/document
Email to the project manager and receive the required data within a month