Determining the effect of topical ketorolac on pain control after hemorrhoidectomy
Design
Two-way blind randomized clinical trial with parallel groups of two to three phases on 84 patients using numerical rating scale (N R S)Enters SPSS software version 21.
Settings and conduct
In this double-blind study, 84 patients with hemorrhoidectomy will attend Ali Ibn Abitaleb Hospital in Rafsanjan.
Participants/Inclusion and exclusion criteria
Entry requirements for ages 15 to 55, ASA I-II
Absence: Patients with Coagulation diseases and patients with a history of gastrointestinal bleeding or peptic ulcer and drug-related patients with a history of uncontrolled diabetes and hypertension and patients who have not received the drug in the 8 hours before surgery.
Intervention groups
Intervention group 1: At the end of the surgery, 4 cc of half a percent marcaine and 1 cc of ketorolac are infiltrated at the surgery site.
Intervention group 2: At the end of the surgery, 4 cc of half a percent marcain is injected at the surgical site and 1 cc of ketorolac is injected at the same time.
Intervention group 3: At the end of the surgery, 4% of the markain is infiltrated by half a percent at the surgical site.
Main outcome variables
Pain score, pain measurement time, received medication, age, sex
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210922052556N1
Registration date:2021-09-30, 1400/07/08
Registration timing:registered_while_recruiting
Last update:2021-09-30, 1400/07/08
Update count:0
Registration date
2021-09-30, 1400/07/08
Registrant information
Name
Negin Shahrokhzadeh kermani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3429 8129
Email address
neginshahrokhzadeh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-01, 1400/02/11
Expected recruitment end date
2021-11-02, 1400/08/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Study of The effect of infiltrative ketorolac on pain relief after hemorroidectomy
Public title
The effect of infiltrative ketorolac on pain relief after hemorroidectomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
ASA I - II patients
15 to 55 years of age
Exclusion criteria:
Patients with coagulation diseases
Patients with a history of gastrointestinal bleeding or a history of gastrointestinal ulcers
Drug-dependent patients
Patients with a history of diabetes and uncontrolled hypertension
Patients who received opioid for pain control 8 hours before surgery.
Age
From 15 years old to 55 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, each participant is given a unique code that analyzes the data and participants are unaware of which group the assigned code belongs to.
Placebo
Not used
Assignment
Parallel
Other design features
Participants in this study are divided into three intervention (case) groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشکده علوم پزشکی رفسنجان
Street address
Imam Ali St. Ali Ibn Abitaleb Hospital
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2021-01-29, 1399/11/10
Ethics committee reference number
IR.RUMS.REC.1399.242
Health conditions studied
1
Description of health condition studied
Hemorrhoids
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Intensity of pain
Timepoint
Immediately after hemorrhoidectomy and 6 hours after hemorrhoidectomy and 12 hours after hemorrhoidectomy and 24 hours after hemorrhoidectomy
Method of measurement
Using NRS (pain rating system from 0 to 10)
Secondary outcomes
1
Description
Medication received
Timepoint
Immediately after hemorrhoidectomy and 6 hours after hemorrhoidectomy and 12 hours after hemorrhoidectomy and 24 hours after hemorrhoidectomy
Method of measurement
View
Intervention groups
1
Description
Intervention group 1: At the end of the surgery, 4 cc of half a percent marcaine and 1 cc of ketorolac are infiltrated at the surgery site.
Category
N/A
2
Description
Intervention group 2: At the end of the surgery, 4 cc of half a percent marcain is injected at the surgical site and 1 cc of ketorolac injected at the same time.
Category
N/A
3
Description
Intervention group 3: At the end of the surgery, 4% of the markain is infiltrated by half a percent at the surgical site.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ibn Abitaleb Hospital in Rafsanjan
Full name of responsible person
Negin Shahrokhzadeh Kermani
Street address
Ali Ibn Abitaleb Hospital ,Imam Ali Blvdlvd.
City
Rafsanjan
Province
Kerman
Postal code
7717966996
Phone
+98 34 3429 8129
Email
neginshahrokhzadeh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Shamsizadeh
Street address
Imam Ali Boulevard, Rafsanjan University of Medical Sciences
City
Rafsanjan
Province
Kerman
Postal code
7717966996
Phone
+98 34 3429 8129
Email
AliShamsy@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Negin Shahrokhzadeh Kermani
Position
Resident anesthesia
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No. 16 Laleh Ave.
City
Rafsanjan
Province
Kerman
Postal code
7717966996
Phone
+98 34 3429 8129
Email
neginshahrokhzadeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Negin Shahrokhzadeh Kermani
Position
Resident anesthesia
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No. 16 Laleh Ave.
City
Rafsanjan
Province
Kerman
Postal code
7717966996
Phone
+98 34 3429 8129
Email
neginshahrokhzadeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Negin Shahrokhzadeh Kermani
Position
Resident anesthesia
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No. 16 Laleh Ave.
City
Rafsanjan
Province
Kerman
Postal code
7717966996
Phone
+98 34 3429 8129
Email
neginshahrokhzadeh@yahoo.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