Evaluation of effect of site of catheter for bupivacain administration in midline laparotomy on postoperative pain in Shariati hospital patients in 2011-2012
The objective of this randomized controlled trial is to compare the effect of site of administration of Bupivacain with catheter into the midline laparotomy wound on postoperative pain (Over or between fascia). Informed consent is taken before enrollment in the study. A total of 60 patients with midline laparotomy (20-30 cm incision) are randomly assigned into one of the two groups: "Catheter on the fascia" and "Catheter between layers of rectus muscle". 20 cc of bupivacain 0.25% are administered via each catheter every 6 hours for 48 hours. The pain is assessed by visual analogue score each 12 hours by a blinded observer. Analgesia by narcotics are administered by patient-controlled analgesia system (bolus dose = 1mg morphine sulphate with 8 min lock-out time) and the need for narcotics are compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138810142982N1
Registration date:2011-11-04, 1390/08/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-11-04, 1390/08/13
Registrant information
Name
Zhamak Khorgami
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2450
Email address
khorgami@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2011-03-21, 1390/01/01
Expected recruitment end date
2012-02-20, 1390/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of site of catheter for bupivacain administration in midline laparotomy on postoperative pain in Shariati hospital patients in 2011-2012
Public title
Effect of site of catheter for bupivacain administration in laparotomy wound on postoperative pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients undergoing midline laparotomy for elective surgeries and sign informed consent for participating in the study
Exclusion Criteria: substance abuse, no appropriate verbal communication, simultaneous other incisions, critically ill or unstable patients, being unconscious or intubated in postoperative period
Age
From 18 years old to 80 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)
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
Central building of Tehran University of Medical Science, Ghods Avenu, Keshavarz Blvd
City
Tehran
Postal code
Approval date
2008-04-18, 1387/01/30
Ethics committee reference number
6688
Health conditions studied
1
Description of health condition studied
Pain management after laparotomy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Total postoperative narcotic consumption
Timepoint
Untill 72 hours based on PCA device
Method of measurement
Patient controlled analgesia device
Secondary outcomes
1
Description
postoperative nausea and vomitting
Timepoint
daily till 48 hours after surgery
Method of measurement
History taking and clinical records
2
Description
postoperative Cardiavascular complications
Timepoint
daily till 48 hours after surgery
Method of measurement
based on medical reocords
3
Description
postoperative pulmonary complications
Timepoint
daily till 48 hours after surgery
Method of measurement
based on medical reocords
4
Description
Wound infection
Timepoint
daily till 5 days after surgery
Method of measurement
Physical examination
5
Description
Hospital stay
Timepoint
At the time of discharge
Method of measurement
based on medical reocords
6
Description
Postoperative pain
Timepoint
12 hours intervals for 3 days
Method of measurement
Visual analogue scale
Intervention groups
1
Description
In group "Catheter between fascia", two infant feeding tubes (6 Fr) - with added holes - are place between rectus muscle and posterior fascia. 20 cc of bupivacain 0.25% are administered via each catheter every 6 hours for 48 hours. The pain is assessed by visual analogue score each 12 hour by a blinded observer. Analgesia by narcotics are used by patient-controlled analgesia system and the need for narcotics are being compared.
Category
Treatment - Surgery
2
Description
In group "Catheter on the fascia", after fascia closure, two infant feeding tubes (6 Fr) - with added holes - are placed over the fascia in subcutaneous space. 20 cc of bupivacain 0.25% are administered via each catheter every 6 hours for 48 hours. The pain was assessed by visual analogue score each 12 hour by a blinded observer. Analgesia by narcotics are used by patient-controlled analgesia system and the need for narcotics are being compared.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Zhamak Khorgami
Street address
Shariati Hospital, North Kargar Avenue,
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Shahin Akhonzade
Street address
Research deputy, Medicine faculty, Poursina avenue, Keshavarz Blvd
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 - Shariati Hospital
Full name of responsible person
Zhamak Khorgami
Position
General Surgeon / faculty of surgery department
Other areas of specialty/work
Street address
Shariati Hospital, North Kargar Avenue
City
Tehran
Postal code
Phone
+98 21 8490 2450
Fax
+98 21 8863 3039
Email
khorgami@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences - Shariati hospital
Full name of responsible person
Zhamak Khorgami
Position
General Surgeon / faculty of surgery department
Other areas of specialty/work
Street address
Shariati Hospital, North Kargar Avenue
City
Tehran
Postal code
Phone
+98 21884902450
Fax
+98 21 8863 3039
Email
khorgami@gmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)