Pain and discomfort after abdominal hysterectomy is high and most of it is due to abdominal incision. Aberrant sensory nerves pass from the fascia between abdominal muscles and with trans-abdominal block we can control pain. We usually use epidural or intravenous narcotics to control pain but these ways have side effects like vomiting. With trans-abdominal block we have a simple way to control pain without entering the epidural space. But unfortunately this method is not well recognized by anesthesiologists, so we decided to do this research and declare its results to anesthesiologists. All patients that have gone under abdominal hysterectomy with pfanenstiel incision and don't have systemic and neurologic diseases will be invited to participate in this study. We will put them randomly in two groups. For the first group we will use trans-abdominal block with pain pump and for other group only pain pump will be used. At 2, 6, 12, 24 and 48 hours after operation we will measure score of pain and satisfaction with Visual Analogue Scale test and Global Clinical Improvement and then we will compare the amount of pain scores and the amount of fantanyle is used in the two groups.
General information
Acronym
A survey on analgesic effects of trans abdominal block
IRCT registration information
IRCT registration number:IRCT2013021012151N1
Registration date:2013-03-10, 1391/12/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-03-10, 1391/12/20
Registrant information
Name
Fariba Almassinokiani
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2202 4187
Email address
f-almasi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-02-28, 1391/12/10
Expected recruitment end date
2014-03-01, 1392/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A survey on analgesic effects of ultrasonographic transabdominal plane block for postoperative pain control of abdominal hysterectomy
Public title
Effects of transabdominal plane block for postoperative pain control of hysterectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All of elective abdominal hysterectomies with pfanenstiel incision will enter to our study.
Exclusion criteria: If the patient doesn’t accept; local anesthetic drugs allergy; infection on injection site; coagulation disorders; medical disorders that interfere with interpretation of pain; addiction to elicit drugs or alcohol; liver or renal insufficiency; sever obesity.
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
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
Tehran University of Medical Sciences
Street address
Poursina street , Enghelab AVE, Tehran , Iran
City
Tehran
Postal code
Approval date
2012-10-08, 1391/07/17
Ethics committee reference number
17543-30-01-91
Health conditions studied
1
Description of health condition studied
Analgesic effect of trans abdominal block on post abdominal hysterectomy pain
ICD-10 code
Z41.8
ICD-10 code description
Other procedures for purposes other than remedying health state
Primary outcomes
1
Description
Severity of post operation pain
Timepoint
2 and 6 and 12 and 24 and 48 hours after operation
Method of measurement
Visual Analogue Scale test
Secondary outcomes
1
Description
Amount of patient's satissfaction from after operation analgesia
Timepoint
2 and 6 and 12 and 24 and 48 hours after operation
Method of measurement
Global Clinical Improvement (GCI) Test
2
Description
The amount of Fantanyle that will be used for pain pump
Timepoint
2 and 6 and 12 and 24 and 48 hours after operation
Method of measurement
Micro geram of fantanyle that will be necessery for pain pump
Intervention groups
1
Description
Intervention group: we use trans abdominal block with pain poump for post abdominal hysterectomy pain control
Category
Other
2
Description
control group : only using pain pump for control of after operation pain
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram Hospital
Full name of responsible person
Dr Farnad Imani
Street address
pain ward ; 4th stage ; Rasoul Akram Hospital ; Niayesh Street ; Sattarkhan Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Fariba Almassinokiani
Street address
Rasoul Akram Hospital , Niayesh street, Sattarkhan street
City
Tehran
Grant name
-----------
Grant code / Reference number
----------
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr Fariba Almassinokiani ; Dr Farnad Imani
Position
Obstetrician and Gynecologist ; Anesthesiologist (pain)
Other areas of specialty/work
Street address
Rasoul Akram Hospital
City
Tehran
Postal code
1445613131
Phone
+98 21 6650 9283
Fax
+98 66509283
Email
f-almasi@sina.tums.ac.ir
Web page address
------------
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Fariba Almassinokiani ; Dr Farnad Imani
Position
Obstetrician and Gynecologist ( Associate profesor) ; Anesthesiologist( Associate profesor)
Other areas of specialty/work
Street address
Rasuol Akram Hospital
City
Tehran
Postal code
1445613131
Phone
+98 21 6650 9283
Fax
+98 66509283
Email
f-almasi@sina.tums.ac.ir
Web page address
-----------------
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fariba Almassinokiani
Position
Gynecologist and Obstetrician and Associate Professor
Other areas of specialty/work
Street address
Rasuol Akram Hospital ; Niayesh Street ; Sattarkhan Street
City
Tehran
Postal code
1445613131
Phone
+98 21 6650 9283
Fax
+98 21 6650 9283
Email
f-almasi@sina.tums.ac.ir
Web page address
---------------
Sharing plan
Deidentified Individual Participant Data Set (IPD)