46 adult patients with renal stones who are candidate for single access subcostal percutaneous nephrolithotomy at Ahvaz Imam Khomeini hospital by a single surgeon will be included. Patients will randomly allocate through a computer generated randomization, in a double blinded fashion to bupivacaine treatment group (Intervention group), and saline infiltration group (Control group). All percutaneous nephrolithotomies will be done in a standard aseptic manner and in the prone position under general anesthesia. A 20 F nephrostomy catheter will be left in place after the operations. In the intervention group under fluoroscopic guidance a 23 gauge spinal needle will be introduced along the nephrostomy catheter to the two-thirds of the puncture depth and 15 cc bupivacaine 0.25% will be injected. Afterwards 10 ml drug will be infiltrated around the nephrostomy catheter subcutaneously. Finally the skin will be infiltrated with 5 cc bupivacaine. In control group normal saline will be infiltrated with the same technique. Postoperative pain scores will be collected using a 10 cm self-assessed visual analog scale with 0 being no pain and 10 being the worst pain experienced by the patient. Pain status and analgesic used will be evaluated at 0, 2, 4, 6, 8 and 24 hours. The visual analog scale scores and total dose of analgesics of the two groups will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015112122168N3
Registration date:2015-12-02, 1394/09/11
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-12-02, 1394/09/11
Registrant information
Name
Dinyar Khazaeli
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3221 0695
Email address
khazaeli-d@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Vice-Chancellor, Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-03-05, 1394/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To evaluate the effect of bupivacaine injection around nephrostomy tract on reduction of post operative pain after percutaneous nephrolithotomy
Public title
bupivacaine effect to reduce postoperative pain after percutaneous nephrolithotomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients with kidney stone who are candidate for after percutaneous nephrolithotomy and in age range of 18 to 60 years old.
Exclusion criteria: cardiovascular disease; Bupivacaine hypersensitivity; renal or skeletal anomalies.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
46
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
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
ground floor, Ahvaz Jundishapur University of Medical Sciences, Golestan BLvd.
City
Ahvaz
Postal code
1579461357
Approval date
2015-05-28, 1394/03/07
Ethics committee reference number
IR.AJUMS.REC.1394.367
Health conditions studied
1
Description of health condition studied
Nephrolithiasis
ICD-10 code
N20.0
ICD-10 code description
Nephrolithiasis
Primary outcomes
1
Description
Amount of pain
Timepoint
At 0, 2, 4, 6, 8 and 24 hours after the surgery
Method of measurement
Based on pain visual analog scale which is filled by the patient from 0 to 10
2
Description
The amount of pethidine used
Timepoint
At 0, 2, 4, 6, 8 and 25 hours after the surgery
Method of measurement
The amount of used drug in miligram
Secondary outcomes
1
Description
Side effects
Timepoint
24 hours after the surgery
Method of measurement
Any changes in blood pressure and cardiac arrhythmias
Intervention groups
1
Description
Intervention group: at the end of percutaneous nephrolithotomy, 30 cc of 0.25% bupivacaine will be injected around the nephrostomy tube
Category
Treatment - Drugs
2
Description
control group: at the end of percutaneous nephrolithotomy, 30 cc of normal saline will be injected around the nephrostomy tube
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr. Dinyar Khazaeli
Street address
Azadegan Avenue
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for research and tech, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Nader Saki
Street address
Office of Vice-chancellor of research and technology, ground floor, Ahvaz Jundishapur University of Medical Sciences, Golestan BLvd.
City
Ahvaz
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 tech, Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Dinyar Khazaeli
Position
Fellowship of uro-oncology, Assistant Professor of Urology, Research Vice-Chancellor of Imam Khomein
Other areas of specialty/work
Street address
Imam Khomeini Hospital
City
Ahvaz
Postal code
15794-61357
Phone
+98 61 3222 2114
Fax
Email
khazaeli_dinyar@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Dinyar Khazaeli
Position
Fellowship of uro-oncology, Assistant Professor of Urology, Research Vice-Chancellor of Imam Khomein
Other areas of specialty/work
Street address
Imam Khomeini Hospital
City
Ahvaz
Postal code
15794-61357
Phone
+98 61 3222 2114
Fax
Email
khazaeli_dinyar@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Dinyar Khazaeli
Position
Fellowship of uro-oncology, Assistant Professor of Urology, Research Vice-Chancellor of Imam Khomein
Other areas of specialty/work
Street address
Imam Khomeini Hospital
City
Ahvaz
Postal code
15794-61357
Phone
+98 61 3222 2114
Fax
Email
khazaeli_dinyar@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)