Sixty ASA grade I &II patients, 12 to 75 years of age, of either sex were randomized to receive 20 ml of 0.25% bupivacaine (group case) or not (group control) through 23-gauge spinal needle along the nephrostomy tube under fluroscopic guidance at the end of the surgery. Postoperative pain score was assessed by NRS(Numericale Rating Scale). All patients were informed about the possibility of experiencing short periods of discomfort or pain and completed NRS questionnaires during the intra-operation and at 6,12, and 24 h postoperatively. Time to first demand analgesia and total dose of narcotic in first 24 hours was noted.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201210235521N2
Registration date:2013-05-05, 1392/02/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-05-05, 1392/02/15
Registrant information
Name
shahriar amirhassani
Name of organization / entity
hamadan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 918 812 7721
Email address
amirhassani@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Sciences
Expected recruitment start date
2011-12-21, 1390/09/30
Expected recruitment end date
2012-08-21, 1391/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Peritubal Local Anesthetic Infiltration in Alleviating postoperative pain in percutaneous Nephrolithotomy
Public title
Decreasing pain after PCNL
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: the patient with any size of renal stone that refer to Beheshti hospital, Hamadan, Iran for renal stone treatment and is candidate for PCNL and being volunteer to participate in our study.
Exclusion criteria: having more than 2 nephrostomy tube; having significant hematuria; having any residual stone after surgery; having any contraindication for PCNL and
do not be volunteer.
Age
No age limit
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
Hamedan University of Medical Sciences Ethics Committee
Street address
Hamedan University of Medical Sciences
City
Hamedan
Postal code
Approval date
2011-10-02, 1390/07/10
Ethics committee reference number
1101/9/35/16/P/D
Health conditions studied
1
Description of health condition studied
kidney calculi
ICD-10 code
N20-N23
ICD-10 code description
Calculus of kidney and ureter,Unspecified renal colic
Primary outcomes
1
Description
Pain after PCNL
Timepoint
Recovery, 6, 12, 24 hours after surgery
Method of measurement
Numerical rating scale
Secondary outcomes
1
Description
The first need of analgesic
Timepoint
The first 24 r after surgery
Method of measurement
Interval of surgery end and the first need of analgesic (hours)
2
Description
Dose of analgesic in first 24 hours post operation period
Timepoint
First 24 hours post operation period
Method of measurement
Dose of analgesic (mg)
Intervention groups
1
Description
Intervention group: receive 20 ml of 0.25% bupivacaine around nephrostomy tube from capsule to skin after surgery
Category
Other
2
Description
Control group: no Intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Dr Shahriar Amirhassani
Street address
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research and technology, Hamadan University of Medical Sciences
Full name of responsible person
Haidar Tavilani
Street address
Hamadan University of Medical Sciences, Fahmideh blvd
City
Hamadan
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 and technology, Hamadan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr Shahriar Amirhassani
Position
urologist/attend
Other areas of specialty/work
Street address
Urology department, Beheshti hospital, Eram blvd
City
Hamadan
Postal code
Phone
+98 81 1838 0703
Fax
Email
amirhassani@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr Shahriar Amirhassani
Position
Urologist
Other areas of specialty/work
Street address
Shahid Beheshti Hospital
City
Hamadan
Postal code
Phone
+98 81 1838 0703
Fax
Email
amirhassani@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr Shahriar Amirhassani
Position
Urologist/attend
Other areas of specialty/work
Street address
Urology department, Beheshti hospital, Eram blvd
City
Hamadan
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)