Protocol summary

Summary
The aim of this study was to evaluate the effectiveness of rectus sheet block under gide of ulterasounde in reduced pain after abdominal surgery whit midline insision and thereby reduce consumption of opium .inclusion craiteria are all elective surgery whit mid line insision : paitiont whit 18 to 79 years old and ASA class 1-2 Who agrees to carry out the plan.paition whit BMI over 35; chronic use of opium and Psychotropic drugs;any complication in surgery ; sensitivity to Bupivacaine ; and Emergent surgery exclluded from study . sample size is 60 person .paiationt randomizede divide in tw group .in intervation group : at the end of surgery befor extubation adminestrade both rectus sheet block in gide of ulterasounde and befor discharg of recovery unite pation take a PCA include morphin and Apotel whit no blouse dose and 0 rate of pomp. in control group such as intervation group , after surgery and befor discharge as recovery unite pation take a PCA white same Specifications The primary consequence of drug consumption in the first twenty-four hours after the operation was evalluated

General information

Acronym
RSB
IRCT registration information
IRCT registration number: IRCT2015052615696N2
Registration date: 2016-07-02, 1395/04/12
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-07-02, 1395/04/12
Registrant information
Name
Afshin Farhanchi
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1825 1244
Email address
farhanchi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research and technology, Hamedan University of Medical Sciences
Expected recruitment start date
2015-05-31, 1394/03/10
Expected recruitment end date
2016-04-19, 1395/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of rectus sheath block whit ultrasod gide in abdominal surgery with mid line inscision BESAT hospital HAMADAN in 1394
Public title
Effectiveness of rectus sheath block in abdominal surgery
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion : age ;ASA class ; persian speaking and aggriation to htis study exclusion : disagriation ; infection or scar in insicion site ;sensitivity to bupivacaien ; chronic adiction ; any surgical pittwal or complications that not adequate for block ;sleep disorders ;sever obesity BMI over 33
Age
From 17 years old to 79 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
hamadan medical university
Street address
shariyati square hamadan Iran
City
Hamadan
Postal code
651738678
Approval date
2015-06-23, 1394/04/02
Ethics committee reference number
IR.UMSHA.REC.1394.158

Health conditions studied

1

Description of health condition studied
abdominal pain
ICD-10 code
R10
ICD-10 code description
Abdominal and pelvic pain

Primary outcomes

1

Description
poat operative pain
Timepoint
each 1 hour for 6 hour
Method of measurement
VAS

Secondary outcomes

1

Description
post operative vomitting
Timepoint
each 1 h for 6 h
Method of measurement
number of ondansetron injection

2

Description
post operative opiume use
Timepoint
each 1 h for 6 h
Method of measurement
loss of PCA as cc

Intervention groups

1

Description
after surgery and befor extubation and derssing ,with ultrasond gide ,visibel bolck needel used 20 cc bupivacain 0.125 % in both rectus sheeth and aftr extubation adminestarade PCA in isolated IV line include morphine 5 mg and apotel 2 gr , infusion rate are 0 , no buluse dose peaple initialy accepted this study
Category
Rehabilitation

2

Description
in control group , after acceptance , adminstrated PCA from isolated iv line , include morphin 5 mg & apotel 2 gr in 100 cc normal salin, rate of infusion is 0 and no buluse dose.as intervation group this gr
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Farhanchi Afshin md /Keneshlou Farzaneh md
Street address
Best Hospital Motahari blv Hamedan
City
Hamedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeid Bashirian
Street address
Hamadan Lona park Hamedan University of Medical Sciences Vice Chancellor for Reasarch and Technology
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Farzaneh Keneshlou
Position
resident of anesthesiplogy
Other areas of specialty/work
Street address
no 10 Golestan Aley Shokriyeh blv Hamedan
City
Hamadan
Postal code
6516739917
Phone
+98 81 3826 2708
Fax
Email
drfkeneshlou@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Afshin Farhanchi
Position
Assistant of Anesthesiology and Critical care
Other areas of specialty/work
Street address
Hamedan University of Medical Science
City
Hamedan
Postal code
6516739917
Phone
+98 81 3264 0022
Fax
Email
farhanchi@umsha.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Farzaneh Keneshlou
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Hamedan Shokrieh Yas Emarat-No.10
City
Hamedan
Postal code
6516739917
Phone
+98 81 3826 2708
Fax
Email
drfkeneshlou@yahoo.com
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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