The study investigates effect of spinal anesthesia and ischio rectal block on methods on the intensity of pain after Hemorrhoidectomy in patients with hemorrhoids. Sampling random- consciously planned. Data will be collected in Shohadaye ashayer hospital of Khorramabad. Inclusion criteria to study are patients in the age range 18-64 years who are candidates forelective hemorrhoidectomy surgery. Exclusion criteria of study are: hemorrhoids grade 4, high BMI or equal 30,Persons with cardiovascular disease, Persons with blood clotting problems, allergic persons to local anesthesia,Persons with ASA class 3 and 4, those taking anticoagulantsand emergency surgery. Of 70 samples, 35 of them receive spinal anesthesia and 35 of them receive ischio rectal blockon. In this study intervention is cavity block ischiorectal. Duration of study in intervention is taking the first painkiller until discharge patient from hospital - 2 to 3 days - . Collecting of Data is predicted in 6 months. The primary outcome of the study is reduce pain and taking painkiller due to using cavity block ischiorectal in hemorrhoid surgery
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015111616516N3
Registration date:2016-01-25, 1394/11/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-25, 1394/11/05
Registrant information
Name
Sadeghe Nadri
Name of organization / entity
Lorestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 3322 3004
Email address
dr.s.nadri@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Lorestan University of Medical Sciences, Department of Research and Technology
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of spinal anesthesia and ischiorectal block on post hemorrhoidectomy pain after hemorrhoidectomy grade 2 and 3
Public title
Effect of spinal anesthesia and ischiorectal block on post hemorrhoidectomy pain after hemorrhoidectomy grade 2 and 3
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Candidates forelective hemorrhoidssurgery - age range 18-64 years - , Hemorrhoids grade 2 and 3.
Exclusion criteria:high BMI or equal 30, Hemorrhoids grade 4, Persons with cardiovascular disease, allergic persons to local anesthesia, Persons with ASA class 3 and 4, Persons with blood clotting problems and those taking anticoagulants
Age
From 18 years old to 64 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of the University of Medical Sciences
Street address
Deputy of Research and Technology,Integrated Paradise,Lorestan University of Medical Sciences,5 km Khorramabad- Tehran,Khorramabad
City
Khorramabad
Postal code
Approval date
2015-11-03, 1394/08/12
Ethics committee reference number
lums.REC.1394.34
Health conditions studied
1
Description of health condition studied
Anesthesia
ICD-10 code
Y48.4
ICD-10 code description
Anaesthetic, unspecified
Primary outcomes
1
Description
The intensity of pain after hemorrhoid surgery
Timepoint
Duration of taking of initial analgesic , second and third day
Method of measurement
The visual analouqe scale
2
Description
Level of Complications after anesthesia
Timepoint
Duration of taking of initial analgesic , second and third day
Method of measurement
Clinical examination and history taking
Secondary outcomes
1
Description
Patient satisfaction after hemorrhoidectomy
Timepoint
After surgery until discharge
Method of measurement
Surveys from patients
2
Description
Reduction in urinary retention and constipation
Timepoint
After surgery until discharge
Method of measurement
Biographies of the patient
Intervention groups
1
Description
block ischiorectalinHemorrhoidectomyin spinal anesthesia group
Category
Other
2
Description
block ischiorectal in Hemorrhoidectomy in block ischiorectal anesthesia group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Ashayer Hospital in Khorramabad
Full name of responsible person
Dr.sadegheh nadri
Street address
Department Of Anesthesiology, Shohada Ashayer Hospital, Revolution Street, Khorramabad
City
Khorramabad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Dr.Morovat Tahari Kalani
Street address
Vice President for research and technology, Paradise university complex, Lorestan University of Medical Sciences, Khorramabad
City
Khorramabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Lorestan 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
Lorestan University Of Medical Sciences
Full name of responsible person
Shirin Rokrok
Position
Medical Student
Other areas of specialty/work
Street address
Department of Clinical Education, Shohada Ashayer Hospita, Khorramabad
City
Khorramabad
Postal code
Phone
+98 66333323004
Fax
Email
shi.rokrok@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Dr.Sdegheh Nadri
Position
Anesthesiologist
Other areas of specialty/work
Street address
Department of Anesthesiology, Shohada Ashayer Hospital, Khorramabad