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The effect of intratechal bupivacaine versus intratechal meperdine on posr operative urinary retention in anorectal surgery

Protocol summary

Summary
After getting the approval of the local committee of ethics in Bushehr University of Medical Sciences, 78 patients whose age were 25 to 45 and are candidates for elective hemorrhoid surgery were randomly allocated into two groups. Control group received 5 mg standard bupivaqcaine 0.5%, intratechaly, Experimental group received 50 mg meperdine, intratechaly. Shivering, hemodynamic changes, nausea and vomiting, pain and urinary retention measured by the responsible nurse. The level of anesthesia in all four groups was: S2-S4.The site of needle insertion was T4-T5 by gauge number 24. The monitoring in the two groups were the same (NIBPM, Pulse oximetry, heart rate in minutes: 1, 3, 10, 20, 30, 60 and in recovery room. Shivering was classified as CROOSLY described. Urinary retention grade were: 0=none, 1=hesitancy, 2=strait catheter required and 4=foly catheter required

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201110201936N7
Registration date: 2011-11-08, 1390/08/17
Registration timing: prospective

Last update:
Update count: 0
Registration date
2011-11-08, 1390/08/17
Registrant information
Name
Abdolreza Najafi Anaraki
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77 1354 0088
Email address
najafianaraki@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Bushehr University of Medical Sciences
Expected recruitment start date
2011-12-01, 1390/09/10
Expected recruitment end date
2012-05-15, 1391/02/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intratechal bupivacaine versus intratechal meperdine on posr operative urinary retention in anorectal surgery
Public title
The effect of intratechal bupivacaine versus intratechal meperdine on posr operative urinary retention in anorectal surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: The patients' age between 25 to 45 and being candidate for hemorrhoid surgery (grade 11 -GRADE1V). Exclusion criteria: diabetes mellitus; history of urinary obstruction, major trauma of pelvis and any sign of neurological bladder
Age
From 25 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 78
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Bushehr University of Medical Sciences
Street address
Bushehr-siraf avenue
City
Bushehr
Postal code
Approval date
2011-10-20, 1390/07/28
Ethics committee reference number
B-90-13-8

Health conditions studied

1

Description of health condition studied
Post operative urinary retention
ICD-10 code
N32.9
ICD-10 code description
Bladder disorder, unspecified

Primary outcomes

1

Description
Post operative urinary retention
Timepoint
Six hours after surgery
Method of measurement
Observation

Secondary outcomes

1

Description
Pain Score
Timepoint
Till 12 hours after surgery
Method of measurement
Observation

Intervention groups

1

Description
Control group receive 5 mg of bupivacaine, Bupivacaine is a mide local anesthetic and will be injected once intrathecally in concentratioin of 0.5% before surgery
Category
Treatment - Drugs

2

Description
Intervention group receive 50 mg of meperdine. Meperdine is an opioid with some local anesthetic effect and will be injected once intrathecally in dose of 50 mg equals to one milliliter before surgery
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Fateme Zahra hospital
Full name of responsible person
Dr. Najafianaraki
Street address
City
Bushehr

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Dr. Afshin Ostovar
Street address
Siraf avenue
City
Bushehr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bushehr 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
Bushehr University of Medical Sciences
Full name of responsible person
Dr Abdolreza Najafianaraki
Position
Assistant professor
Other areas of specialty/work
Street address
Siraf avenue
City
Bushehr
Postal code
Phone
+98 77 1252 6801
Fax
Email
arna566@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Dr. Najafianaraki
Position
Assistant prof
Other areas of specialty/work
Street address
Siraf avenue
City
Bushehr
Postal code
Phone
+98 77 1252 6801
Fax
Email
arna566@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Dr. Najafianaraki
Position
Assistant prof
Other areas of specialty/work
Street address
Bushehr-siraf
City
Bushehr
Postal code
Phone
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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