The aim of this study is the effect of intraperitoneal lidocain on pain after abdominal hysterectomy. The exclusion criteria are: positive history of hepatits; cardiovascular diseases; hypersensitivity to local analgesic agents; history of conclusion; asthma; addiction; cancer and concomitant surgeries. Fourthly patients who are candidate for abdominal hysterectomy will be recruited after giving informed consent and be randomly allocated in two groups: intervention and control. All patients undergo abdominal hysterectomy under general anesthesia. At the end of operation in supine position one of this two solution(50cc of 0.9% normal saline or 50cc of lidocain 0.8% plus epinephrine 1/50000 will be infiltrated to the peritoneal cavity and then abdomen be closed. A patient with complication & any patient that the operation lasts more than 2hours will be excluded from study. At the end all patients will be compared from the point of pain score after 12, 24 and 48 hours after operation, side effects, and the dose of narcotic & raise of satisfaction.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201207021306N6
Registration date:2012-07-18, 1391/04/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-07-18, 1391/04/28
Registrant information
Name
Ziba Zahiri
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1322 5624
Email address
drzibazahiri@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research-Guilan University of Medical Sciences
Expected recruitment start date
2007-06-17, 1386/03/27
Expected recruitment end date
2008-07-07, 1387/04/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Intraperitoneal lidocaine on pain after abdominal hysterectomy
Public title
The effect of lidocaine on pain after abdominal hysterectomy surgery
Purpose
Treatment
Inclusion/Exclusion criteria
The exclusion criteria are: positive history of hepatits; cardiovascular diseases; hypersensitivity to local analgesic agents; history of conclusion; asthma; addiction; cancer and concomitant surgeries. Inclusion criterion: all patient who are candidate for abdominal of hysterectomy.
Age
From 15 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Guilan University of Medical Sciences
Street address
Road Tehran, Faculty of Medicine
City
Rasht
Postal code
Approval date
2007-05-22, 1386/03/01
Ethics committee reference number
431
Health conditions studied
1
Description of health condition studied
Single delivery by caesarean section
ICD-10 code
O82
ICD-10 code description
O82.0
Primary outcomes
1
Description
Evaluation of Pain
Timepoint
At hours 8, 12, 24 and 48 hours after surgery and after surgery at the time of movement
Method of measurement
Visual pain scale
Secondary outcomes
1
Description
Side effects (dizziness, vomiting, nausea)
Timepoint
Within 24 hours after surgery.
Method of measurement
By Assistant
2
Description
Dosage of drugs
Timepoint
Within 24 hours after surgery.
Method of measurement
By Assistant
3
Description
Satisfaction levels
Timepoint
Within 24 hours after surgery.
Method of measurement
Ask the patient
Intervention groups
1
Description
At the end of operation number1 solution(50cc of 0.9% normal saline ) infiltrated within peritoneal cavity and then abdomen was closed
Category
Treatment - Drugs
2
Description
At the end of operation number 2 solution( 50cc of lidocain 0.8% plus epinephrine 1/50000) was infiltrate to the peritoneal cavity and then abdomen was closed
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Street address
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research-Guilan University of Medical Sciences
Full name of responsible person
Dr. Abdolrasol Sobhani
Street address
Vice Chancellor for research-Guilan University of Medical Sciences l, Namjoo street
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research-Guilan 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr.Ziba Zahiri
Position
Associated professor Guilan university of Medical Science
Other areas of specialty/work
Street address
Rasht.Namjo street.Alzahra hospital.Reproductive Health Research Center
City
Rasht
Postal code
Phone
+98 13 1322 5624
Fax
Email
drzibazahiri@yahoo.com; h_fertility@gums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Seyedeh Fatemeh Dalil Heirati
Position
B.S.midwife
Other areas of specialty/work
Street address
Reproduction Health research center-Alzahra hospital-Namjo street
City
Rasht
Postal code
Phone
Fax
Email
h_fertility@gums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)