The purpose of study is evaluation of effect of Ropivacaine on post-operative pain, opium need and respiratory changes after "Percutaneous Nephrolitotomy operation". Inclusion criteria: Age: 15-60 years, weight less than 40kg. Exclusion criteria: Too many kidney stones which Ropivacaine administration reaches over dosage, retained Kidney stone after operation. 60 patients scheduled for "Percutaneous Nephrolitotomy" at the end of surgery 30 ml Ropivacaine will be injected to the study group. Control group will be received the same amount and manner Isotonic Saline. After 4 and 6 hour of the surgery, pain score and peak expiratory flow rate of the patients will be measured. The amount of analgesic during 6 hour will be documented.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201307153773N8
Registration date:2015-01-15, 1393/10/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-01-15, 1393/10/25
Registrant information
Name
Farsad Imani
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 21 4469 0816
Email address
imanifar@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-07-23, 1392/05/01
Expected recruitment end date
2014-07-23, 1393/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Ropivacaine on post-operative pain after Transcataneous Percataneous Nepholytotomy
Public title
The effect of Ropivacaine on post-operative pain after Transcataneous Percataneous Nepholytotomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age:15-60 y; Weight less than 40kg; Percataneous Nepholytotomy operation.
Exclusion criteria: Too many kidney stones which Ropivacaine administration reaches over dosage; Retained Kidney stone after operation.
Age
From 15 years old to 60 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
Keshavrs Blv. Ghods St. Cross
City
Tehran
Postal code
Approval date
2014-12-14, 1393/09/23
Ethics committee reference number
9011174017-125187
Health conditions studied
1
Description of health condition studied
Pain after Percutaneous Nephrolithotomy
ICD-10 code
N20.0
ICD-10 code description
Calculus of kidney
Primary outcomes
1
Description
pain
Timepoint
4 and 6 h after operation
Method of measurement
VAS (Visual analogue scale)
2
Description
Peak End Expiratory Flow Rate
Timepoint
Before operation/6&4 hour after operation
Method of measurement
Blowing at Peak Flow Meter
Secondary outcomes
1
Description
Peak expiratory flow rate
Timepoint
4 & 6 h after operation
Method of measurement
Ambulatory PEFmeter
Intervention groups
1
Description
At the end of the operation, patients of intervention group, 30 mL of 0. 2% ropivacaine will be instilled into the renal puncture site, nephrostomy tract, and skin. Postoperatively, patients received Apotel I.V. (Acetaminophen) 1g. Pain visual analog score (VAS), peak expiratory flow rate (PEF) will be measured at 4, 6 hours postoperatively. The number of analgesic doses required will be recorded.
Category
Treatment - Drugs
2
Description
At the end of the operation, patients of control group, 30 mL of saline will be instilled into the renal puncture site, nephrostomy tract, and skin. Postoperatively, patients received Apotel I.V. (Acetaminophen) 1g. Pain visual analog score (VAS), peak expiratory flow rate (PEF) will be measured at 4, 6 hours postoperatively. The number of analgesic doses required will be recorded.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Farsad Imani
Street address
Imam Khomeini St. Hasanabad Sq.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masud Yunesian
Street address
Department of Environmental Health Engineering, School of Public Health, Tehran University of Medical Sciences
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
Farsad Imani M.D.
Position
Assitant Professore
Other areas of specialty/work
Street address
Imam Khomeini St. Hasanabad Sq.
City
Tehran
Postal code
Phone
+98 21 63120
Fax
Email
imanifar@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
Seyed Reza Hoseini M.D.
Position
Associated Professore
Other areas of specialty/work
Street address
Imam Khomeini St. Hasanabad Sq. Sina Hospital
City
Tehran
Postal code
Phone
+98 21 63120
Fax
Email
srhoseini@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
Somayyeh Zamani M.D.
Position
Anesthesiologist
Other areas of specialty/work
Street address
Imam Khomeini St. Hasanabad Sq. Sina Hospital
City
Tehran
Postal code
Phone
+98 21 63120
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)