Comparison the effect of tolterodine and gabapentin in reducing pain and discomfort of catheter after Percutaneous nephrolithotomy surgery at Hashemi Nejad Hospital
In this study, we will analyse the effect of Tolterodine and Gabapentin in reducing pain and discomfort of catheter after Percutaneous nephrolithotomy surgery.100 patients of PCNL surgery candidate are included. After recording of their demographic data and past medical history into checklists, they divided to three groups with balance blocked randomization. First group are getting placebo, second and third group are getting Gabapentin and Tolterodine. The placebo group includes people who feel discomfort after PCNL in the lumen of the catheter after extubation are taking opioid analgesic drug 25 mg per injection. Group 1 consists of people who are taken Tolterodine 2mg orally 1 hour before surgery and Group 2 are taken Gabapentin 600mg (2 capsules Gabapentin 300mg) 1 hour before the surgery.Then, 1 , 3, 6, 12 and 24 hours after extubation and at the time of requesting rescue drug ,the pain of people are recorded by VAS score (visual analog scale).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204066504N3
Registration date:2016-12-07, 1395/09/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-07, 1395/09/17
Registrant information
Name
Robab Maghsoudi
Name of organization / entity
Iran University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8864 4486
Email address
robab.maghsoudi@hkc.ir
Recruitment status
Recruitment complete
Funding source
Iran University Of Medical Sciences
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of tolterodine and gabapentin in reducing pain and discomfort of catheter after Percutaneous nephrolithotomy surgery at Hashemi Nejad Hospital
Public title
The effect of tolterodine and gabapentin in reducing pain and discomfort after surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: PCNL surgery candidate; Older than 18 years old; Risk of anesthesia was ASA 1
Exclusion criteria: Alchohol or drug abuse; Sensetivity to gabapentin, tolterodine or opioids; Using opioids 12 hour before syrgery; Any confounding medical or psychological situation of patients
Age
From 18 years old to 60 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Iran University of Medical Sciences ,hemmat expresway, Tehran, Iran
City
Tehran
Postal code
Approval date
2016-05-24, 1395/03/04
Ethics committee reference number
IR.IUMS.REC1395.9221254002
Health conditions studied
1
Description of health condition studied
Nephrolithiasis
ICD-10 code
N22.8
ICD-10 code description
Calculus of urinary tract in other diseases classified elsewhere
Primary outcomes
1
Description
Pain of cathetring
Timepoint
1,3,6,12 and 24 hours after PCNL surgery
Method of measurement
Visual analouge scale questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The placebo group includes people who feel discomfort after PCNL in the lumen of the catheter after extubation are taking opioid analgesic drug 25 mg per injection.
Category
Placebo
2
Description
Intervention: Group 1 consists of people who are taken tolterodine 2mg orally 1 hour before surgery with a little water.
Category
Treatment - Drugs
3
Description
Intervention: Group 2 are taken Gabapentin 600mg (2 capsules Gabapentin 300mg) 1 hour before the surgery. Also, all the people who feel pain and discomfort during the study was prescribed analgesic 25mg.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Hashemi Nejad Hospital
Full name of responsible person
Dr. Saeed Farhadi Niaki
Street address
no 34, Shahid Hashemi Nejad Hospital, Valinejad Avn.,