1) Major eligibility and objectives: Postoperative pain control is a concern after renal transplant and administration of systemic analgesic may be difficult because of underlying co-morbidities, and variable responses of the graft.Our main objective is evaluation the effect of transversus abdominis plane (TAP) block on postoperative pain relief following renal transplantation.
2)Participants:
Inclusion criteria:
1) ASA class II and III patients
2) Aged 15–65 year who were scheduled as kidney recipients under general anesthesia
Exclusion criteria:
1)Addiction to opioids
2)Long term usage of antidepressants, antipsychotics, anticonvulsants, clonidine
3) Patients with coagulopathy and hepatomegaly.
3)Design,setting and conduct :
Forty-four kidney recipients were randomized into two equal groups and were anesthetized with the same technique.
4)Intervention: After the induction of anesthesia,15mL of 0.25% Bupivacaine plus 5µ/ml epinephrine in study group and the same volume of saline in control group was deposited into the transversus abdominis neurofascial plane on the side of surgery by ultrasound guide.
5)Measures and variable criteria: Each patient was assessed by a blinded investigator using NRS at first,4th,8th,12th and24hr postoperatively.
Intraoperative and first 24 hours opioid consumption and demographic data were compared between the study groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012185264N3
Registration date:2012-09-20, 1391/06/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-09-20, 1391/06/30
Registrant information
Name
Sussan Soltani Mohammadi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2229 5296
Email address
soltanmo@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research,Tehran University of Medical Sciences
Expected recruitment start date
2010-11-01, 1389/08/10
Expected recruitment end date
2011-03-01, 1389/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Transversus Abdominis Plane Block for Acute Postoperative Pain Relief in Kidney Recipients, a Double Blinded Clinical Trial
Public title
Efficacy of Transversus Abdominis Plane Block for Acute Postoperative Pain Relief in Kidney Recipients, a Double Blinded Clinical Trial
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
1) ASA class II and III patients
2) Aged 15–65 year who were scheduled as kidney recipients under general anesthesia
Exclusion criteria:
1)Addiction to opioids
2) Long term usage of antidepressants, antipsychotics, anticonvulsants, clonidine
3) Patients with coagulopathy and hepatomegaly.
Age
From 15 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
none
Secondary trial Id
none
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Poorsiina street,Keshavraz blv
City
Tehran
Postal code
14117113135
Approval date
2010-04-20, 1389/01/31
Ethics committee reference number
410
Health conditions studied
1
Description of health condition studied
kidney recipiet,s patients
ICD-10 code
Z94.0
ICD-10 code description
kidney transplant status
Primary outcomes
1
Description
postoperative pain
Timepoint
at 1st , 4th , 8th , 12th and 24h following surgery
Method of measurement
numeric rating scale
Secondary outcomes
1
Description
Intraoperative and first 24 hours opioids consumption
Timepoint
At the end of operation and end of first 24 hours after operation
Method of measurement
Dose calculation in mg
Intervention groups
1
Description
In study group:22 patients were blocked by 15 ml bupivacaine 0.5% + 5 micro-gram/ml epinephrine on the side of surgery and ultrasound guide after induction of anesthesia.The probe was inserted between iliac crest and costal margin behind the midaxillary line.The drug was injected between transverse abdominis neurofascial plane.
Category
Treatment - Drugs
2
Description
In control group ,20 ml normal saline was injected in transverse abdominis neurofascial plane under sonography guide after induction of anesthesia at the side of surgery.The probe was inserted between iliac crest and costal margin behind the midaxillary line.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr Shariati Hospital
Full name of responsible person
Sussan Soltani Mohammadi
Street address
North kargar street, Ale-ahmad highway
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research,Tehran University of Medical Sciences
Full name of responsible person
Dr akbar fotoohi
Street address
Poorsina street,Keshvarz blv
City
Tehran
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,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
Sussan Soltani Mohammadi
Position
Associated professor
Other areas of specialty/work
Street address
North kargar street, Ale-ahmad highway,Dr Shariati Hospital
City
Tehran
Postal code
1411713135
Phone
+98 21 2229 5296
Fax
+92 18863303946774825
Email
soltanmo@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
Sussan Soltani Mohammadi
Position
Associated professor
Other areas of specialty/work
Street address
Dr Shariati Hospital, North kargar street,Ale-ahmad highway
City
Tehran
Postal code
1411713135
Phone
+98 21 2229 5296
Fax
00982188633039(Hospital)
Email
soltanmo@sina.tums.ac.ir
Web page address
-
Person responsible for updating data
Contact
Name of organization / entity
Tehran university of medicalsciences
Full name of responsible person
Sussan Soltani Mohammadi
Position
Associated Professor
Other areas of specialty/work
Street address
Dr Shariati Hospital,North Kargar street,Ale-ahmad highway
City
Tehran
Postal code
14117113135
Phone
+98 21 2229 5296
Fax
+98-21-88633039(Hospital)
Email
soltanmo@sina.tums.ac.ir
Web page address
-
Sharing plan
Deidentified Individual Participant Data Set (IPD)