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The effect of hypogastric block for pain relief in endometriotic patients after completion of both surgical and medical treatment

Protocol summary

Summary
1- Objectives: The effect of hypogastric block for pain relief in endometriotic patients after completion of both surgical and medical treatment 2- Design: This study is performed as a randomized clinical trial. 3- Setting and conduct: After obtaining the approval of the Ethics Committee from Iran University of Medical Sciences and obtaining a clinical practice code from the clinical practice system and receiving written consent from patients with endometriosis referring to the women's ward of Rasoul-e-Akram Hospital; patients will be entered into the study. In the intervention group, the hypoplastic block will be performed by injection of 10 ml of bupivacaine 25% and 40 mg of triamcinolone from the two needles, and in control group the common therapies will be used. 4- Participants including major eligibility criteria: Inclusion criteria: Age of 18-45 patients with endometriosis with proven laparoscopy and despite surgical and medical treatment The mean pain (chronic pelvic pain, dyspnea, or discomfort) is VAS Score 5. Lack of PID, lack of fibroma, lack of adenomyosis, patients need to collaborate. At least three months after the last treatment of the patient's treatment, do not respond to surgical and therapeutic procedures. Exclusion criteria: Patient not cooperating. 5- Intervention: hypogastric block in intervention group and Common treatment in control group 6- main outcome measures : The outcome of this study was pain, which was evaluated using the VAS questionnaire in the intervals of 24 hours, 48 hours, 72 hours, one week and one month after the intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017082923684N3
Registration date: 2017-10-24, 1396/08/02
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-10-24, 1396/08/02
Registrant information
Name
Sepideh Khodaverdi
Name of organization / entity
Iran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2562
Email address
khodaverdi.s@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical science
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of hypogastric block for pain relief in endometriotic patients after completion of both surgical and medical treatment
Public title
The effect of hypogastric block for pain relief in endometriotic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients whose endometriosis has been diagnosed with laparoscopy؛ and despite surgical and medical treatment؛ the average of chronic pelvic pain؛ dyspunia or dysmenorrhea is 5 vas score to above and At least three months have elapsed since their last medication؛ and has not received any drug treatment. And excluded other causes of pelvic pain such as PID, uterine fibroids, adenomyosis, IBS, and urinary problems. Exclusion criteria: Patient's lack of cooperation
Age
From 18 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 32
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Committee of Iran University of Medical science
Street address
Iran University of Medical Sciences, Hemat Highway next to Milad Tower
City
Tehran
Postal code
Approval date
2017-06-21, 1396/03/31
Ethics committee reference number
IR.IUMS.REC 1396.29814

Health conditions studied

1

Description of health condition studied
Endometriosis
ICD-10 code
N80
ICD-10 code description
Endometriosis

Primary outcomes

1

Description
Pain
Timepoint
24 hour- 48 hour-72 hour-1 week-1 month- 3 months- 6 months
Method of measurement
ODI Questionear

Secondary outcomes

empty

Intervention groups

1

Description
Patients are referred to the pain department of Rasoul-e-Akram Hospital for intervention , For the block of the upper hypogastric network, after taking the history and physical examination and Assessing the graphs, the patient's lab tests and the reason for the operation, the expected consequences and the patient's complications are fully explained to the patient. and the patient completes the informed consent form. The patient is lying prone and then setting up the venous route and giving the appropriate sediment with fentanyl and midazolam then taking oxygen nasal cannula and fixing vital signs. Using the fluorescope and the lateral approach of the intercostal space, we identify the fourth and fifth lumbar vertebrae and mark the midline of 7 cm on each side. , and after the local anesthetic, the needle insertion points with lidocaine 1%, the 15 cm needle with the gauge 22 under Fluorescope conduction insert from both sides and in order to ensure its proper location, after aspiration, 3 ml of the solution of the contrast agent was injected from both needle by visual inspection of the contrast material in the latral view on the anterior margin of the trunk and in the posterior, anterior aspect, in the Paramedine area, We will ensure of correct place of the needle. Then the needles will be aspirate and 10 ml of bupivacaine 25% is injected with 40 mg of triamcinolone per needle, and 2-3 hours after injection, the patient will discharge, the patient is not required to be admitted to the department.
Category
Treatment - Surgery

2

Description
In the control group, the patient receives the common drug therapy for pain control.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasoul E Akram Hospital
Full name of responsible person
Dr.Mania Kaveh
Street address
Endometriosis Research Center, Hazrat Rasool Akram Educational and Research Center, Niayesh Avenue, Sattarkhan Ave, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Dr Seeyd KazemMalekouti
Street address
Iran University Of Medical science, side of milad tower, Hemmat highway, Tehran
City
Tehran
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, Iran 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
Iran University of Medical Science
Full name of responsible person
Dr. Mania Kaveh
Position
Assistant of womens Laparoscopic Fellowship
Other areas of specialty/work
Street address
Endometriosis Research Center, Hazrat Rasool Akram Educational and Research Center, Niayesh Avenue, Sattarkhan Ave, Tehran
City
Tehran
Postal code
Phone
+98 21 2562
Fax
Email
maniakaveh@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Dr. Sepideh Khodaverdi
Position
assistant professor
Other areas of specialty/work
Street address
Endometriosis Research Center, Hazrat Rasool Akram Educational and Research Center, Niayesh Avenue, Sattarkhan Ave, Tehran
City
Tehran
Postal code
Phone
+98 21 2562
Fax
Email
sepidehkhodaverdi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Rasoul Akram Hospital
Full name of responsible person
Dr. Mania Kaveh
Position
Fellowship of minimally invasive gynecologic surgery
Other areas of specialty/work
Street address
Endometriosis Research Center, Hazrat Rasool Akram Educational and Research Center, Niayesh Avenue, Sattarkhan Ave, Tehran
City
Tehran
Postal code
1445613131
Phone
+98 21 2562
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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