Protocol summary

Summary
The aim of this study is to determine the effect of intra abdominal wall infiltration with bupivacaine to reduce post operative diclofenac need in elective cesarean sections. Inclusion criteria were: women with first single term pregnancy who are candidate for elective caesarean section, spinal anaesthesia, BMI between 20 to 25 before pregnancy, and time of surgery less than 40 minutes. Exclusion criteria were: bleeding, atonia or any unpredicted accident during or after surgery. fannenstiel incision, opium consumption, underlying disease, history of previous abdominal surgery, sensitivity to amid drugs. In this double- blind, placebo-controlled trial, 60 healthy women with single term pregnancy, after obtaining written informed consent, were randomized into two groups. Patients underwent spinal anesthesia, and then they received a combination of 30cc of 0.25% bupivacaine with 1.5cc of 1:200000 epinephrine as intra abdominal wall infiltration or equal volume of saline in cesarean section at the time of abdominal closure. Pain was assessed using a visual analogue scale 1, 2, 3, 4, 8 and 12 h after the operation. Also mean diclofenac consumption was assessed during 12 h after the operation. The final analysis was done with statistical tests including Chi Square, Non Parametric test and Mann-withny U by SPSS (P<0.05 was considered significant). Mean pain scores after the operation and mean diclofenace consumption in 12 h were compred between two groups. Also the time we prescribed diclofenac was compared between two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138812243574N1
Registration date: 2010-05-29, 1389/03/08
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-05-29, 1389/03/08
Registrant information
Name
Nader Esmalipour
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1322 5624
Email address
esmailpour@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research vice chancellorship -Guilan university of medical sciences
Expected recruitment start date
2008-12-28, 1387/10/08
Expected recruitment end date
2009-09-17, 1388/06/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intra abdominal infiltration with bupivacaine in reducing postoperative diclofenac need in elective cesarean sections.
Public title
The effect of intra abdominal infiltration with bupivacaine in reducing postoperative diclofenac need in elective cesarean sections.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria were: women with first single term pregnancy who are candidate for elective caesarean section, spinal anaesthesia, BMI between 20 to 25 before pregnancy, and time of surgery less than 40 minutes. Exclusion criteria were: bleeding, atonia or any unpredicted accident during or after surgery. fannenstiel incision, opium consumption, underlying disease, history of previous abdominal surgery, sensitivity to amid drugs
Age
From 16 years old to 39 years old
Gender
Female
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)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research vice chancellorship-Guilan university of medical sciences
Street address
Namjo st., Research vice chancellorship, Guilan university of medical sciences
City
Rasht
Postal code
Approval date
2009-10-11, 1388/07/19
Ethics committee reference number
4186

Health conditions studied

1

Description of health condition studied
Delivery by elective caesarean section
ICD-10 code
O82.0
ICD-10 code description
Delivery by elective caesarean section

Primary outcomes

1

Description
Pain Severity
Timepoint
1, 2, 3, 4, 8, and 12 hours after operation
Method of measurement
Visual analogue scale

Secondary outcomes

1

Description
Duration of painless period
Timepoint
1, 2, 3, 4, 8, and 12 hours after operation
Method of measurement
The time span between the end of the operation and the time we prescribed first dose of diclofenac

2

Description
Diclofenac use after operation
Timepoint
Over 12 hours
Method of measurement
Total diclofenac consumption

Intervention groups

1

Description
intra abdominal wall infiltration of 30 cc of 0.25% bupivacaine
Category
Treatment - Drugs

2

Description
intra abdominal wall infiltration of 30 cc normal saline
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Guilan university of medical sciences, Alzahra Hospital
Full name of responsible person
Street address
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research vice chancellorship, Guilan university of medical sciences
Full name of responsible person
Dr Abdolrasol Sobhani
Street address
Namjo st., Research vice chancellorship, Guilan university of medical sciences
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research vice chancellorship, 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
Name of organization / entity
Guilan university of medical sciences
Full name of responsible person
Dr Nader Esmailpour
Position
Assistant Professor of Obstetric and Gynecology, Guilan university of Medical Sciences
Other areas of specialty/work
Street address
Reproductive Health Research center, Department of Ob &Gyn, Alzahra Hospital, Guilan university of Medical Sciences , Namjo st., Rasht
City
Rasht
Postal code
Phone
+98 911 131 5679
Fax
Email
esmailpour@gums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan university of medical sciences
Full name of responsible person
Dr Nader Esmailpour
Position
Assistant professor of Obstetric and Gynecology, Guilan university of Medical Sciences
Other areas of specialty/work
Street address
Reproductive Health Research center, Department of Ob & Gyn, Alzahra Hospital, Guilan university of Medical Sciences, Namjo st., Rasht
City
Rasht
Postal code
Phone
+98 911 131 5679
Fax
Email
esmailpour@gums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Reproductive Health Research center
Full name of responsible person
Seyede Fatemeh Dalil Hirati
Position
Bs in Midwifery
Other areas of specialty/work
Street address
Reproductive Health Research center, Alzahra hospital, Namjo st.,
City
Rasht
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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