Comparison of the effect of adrenalized methylene blue and adrenalized Marcaine in pain relief after haemorrhoidectomy
Design
This study will be performed as a randomized clinical trial (6 blocks), single-blind, without control group, with parallel groups and in phase 2-3 with the participation of 100 patients after hemorrhoidectomy.
Settings and conduct
This study will be performed with the participation of 100 candidates for hemorrhoidectomy in the operating room of Imam Reza Hospital (Tabriz University of Medical Sciences). For patients, methylene blue adrenaline and adrenaline marcaine will be used after surgery. The data analyzer will be unaware of the grouping of patients and will be blind during the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Hemorrhoidectomy surgery and consent to participate in the study and Exclusion criteria: Patients with drug addiction, patients with anal infection, patients with irritable bowel syndrome and patients with preanal fistula.
Intervention groups
In this randomized clinical trial study, 100 patients will be divided into two groups. Immediately after surgery, adrenalized methylene blue will be used for patients in the first group and adrenalized Marcaine will be used for patients in the second group to control their pain, and their rejection rate will be compared during the first 12 hours after surgery.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190325043107N27
Registration date:2022-04-15, 1401/01/26
Registration timing:prospective
Last update:2022-04-15, 1401/01/26
Update count:0
Registration date
2022-04-15, 1401/01/26
Registrant information
Name
Mehdi Khanbabayi Gol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 7054
Email address
khanbabayimehdi69@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-05, 1401/02/15
Expected recruitment end date
2022-09-06, 1401/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of adrenalized methylene blue and adrenalized Marcaine in pain relief after haemorrhoidectomy
Public title
Adrenalized methylene blue and adrenalized Marcaine in pain relief after haemorrhoidectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for hemorrhoidectomy surgery
Satisfaction to participate in the study
Exclusion criteria:
Patients with drug addiction
Patients with anal infection
Patients with irritable bowel syndrome
Patients with perianal fistula
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the block random division method (4 blocks) is used. One of the study partners, for whom no blinding was performed, named the method of treatment of adrenalized methylene blue with the letter A and the method of treatment of adrenalized marcaine with the letter B. The researcher then distributes packages A and B among the patients referred to participate in the study by block random division method (4). Then, from the created blocks, enough blocks are randomly selected to reach the required sample size. To make a random sequence, we give possible blocks (6 blocks) from one to 6 numbers. Depending on the sample size, any number of 4 blocks that are needed will be used. Select the number of blocks from the table of random numbers and based on these numbers, the sequence of blocks in each group will be determined.
Blinding (investigator's opinion)
Single blinded
Blinding description
The statistical consultant of this project will be unaware of the type of grouping of participants; The final results will be delivered to the statistical consultant. As the statistical consultant will not be in the process of grouping the participants; Therefore, he is blind during the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Approval date
2022-04-06, 1401/01/17
Ethics committee reference number
IR.TBZMED.REC.1401.016
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
G89.11
ICD-10 code description
Acute pain due to trauma
Primary outcomes
1
Description
Pain
Timepoint
Before intervention and after intervention for twelve hours (once every hour)
Method of measurement
VAS pain intensity measuring instrument
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Fifty patients will be included in this study after random allocation. After surgery,adrenalinez methylene blue (manufactured by Obaidi) will be injected into the operated area. Pain intensity will be measured for 12 hours after surgery using a VAS instrument.
Category
Treatment - Drugs
2
Description
Intervention group: Fifty patients will be included in this study after random allocation. After the surgery, adrenalinez marcaine (made by Obaidi company) will be injected in the operated area. Pain intensity will be measured for 12 hours after surgery using a VAS instrument.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Ramin Azhoogh
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
6165665631
Phone
+98 21 3335 5921
Email
mkhanbabayi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Phone
+98 41 3335 7310
Email
Shahabi_p@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mohammadreza Dashti
Position
Resident Of General Surgery
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
dashti_mmr@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ramin Azhogh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Azhogh_r@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@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