Evaluation of the Effect of Transdermal Nitroglycerine on Postoperative Analgesia Following Orthopedic Surgery under Spinal Anesthesia with Sufentanil and Lidocaine
Background & Objective: Administration of intrathecal opioid is one of the postoperative analgesia management methods. Experimental data suggests transdermal nitroglycerine (a nitric oxide generator) can enhance analgesic effect of opioids. This study was done to assess the effect of transdermal nitroglycerine on the patients undergoing orthopedic surgery.
Material and Methods: In this prospective, double blinded, clinical trial, 24 patients scheduled for plating of tibia or fibula were randomized to one of two groups. In all of the patients, spinal anesthesia was done with lidocaine 5% (100 mg) and sufentanil
(5 g). After 25 minutes, in 12 patients (nitroglycerine group) transdermal nitroglycerine patch and in the other 12 patients (placebo group) placebo patch was applied at the thorax. Duration of analgesia, pain occurrence, analgesic consumption and visual analogue scale (VAS) in 24 hours after operation were assessed. Data were analyzed by SPSS 11th version, with t-test and Fisher exact test. P<0.05 was considered significant.
General information
Acronym
NTG
IRCT registration information
IRCT registration number:IRCT138905124498N1
Registration date:2004-09-22, 1383/07/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2004-09-22, 1383/07/01
Registrant information
Name
Maryam Davoudi
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1264 0030
Email address
davoudi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan university of medical sciences
Expected recruitment start date
2004-09-22, 1383/07/01
Expected recruitment end date
2005-03-19, 1383/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Transdermal Nitroglycerine on Postoperative Analgesia Following Orthopedic Surgery under Spinal Anesthesia with Sufentanil and Lidocaine
Public title
Effect of Transdermal Nitroglycerine on Postoperative Analgesia
Purpose
Prevention
Inclusion/Exclusion criteria
24 patients scheduled for tibia or fibula plating with ASA class I or II, 18 to 40 years included in study. Exclusion criteria were: history of NTG or lidocaine allergy, history of opium addiction, chronic use of analgesics, circulatory failure, cardiogenic shock and severte hypotension.
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
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
Hamadan university of medical sciences
Street address
Shahid Fahmideh blvd
City
Hamadan
Postal code
Approval date
2004-07-12, 1383/04/22
Ethics committee reference number
897/51/16/پ
Health conditions studied
1
Description of health condition studied
Lower leg fracture
ICD-10 code
S82
ICD-10 code description
Fracture of lower leg, including ankle
Primary outcomes
1
Description
Postoperative analgesia duration
Timepoint
24 hours after operation
Method of measurement
First rescue analgesic request(hours)
Secondary outcomes
1
Description
Postoperative analgesic consumption
Timepoint
24 hours after operation
Method of measurement
Data were recorded in the relevant forms
2
Description
Pain score
Timepoint
24 hours after operation
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
In the placebo group placebo patch was applied in chest area outside the blocked area and left there for 24 hours. Both groups received intravenous infusion at 10 ml/kg
Category
Placebo
2
Description
In the intervention group transdermal nitroglycerine patch was applied in chest area outside the blocked area and left there for 24 hours. Both groups received intravenous infusion at 10 ml/kg
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mobasher Kashani hospital
Full name of responsible person
Maryam Davoudi
Street address
Besat hospital
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamadan university of medical sciences
Full name of responsible person
Hosein Emad Momtaz
Street address
Shahid 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
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
Hamadan university of medical sciences
Full name of responsible person
Maryam Davoudi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Besat hospital
City
Hamadan
Postal code
Phone
+98 81 1264 0030
Fax
+98 81 1265 1515
Email
davoudi@umsha.ac.ir; mdavoudi10@yahoo.com
Web page address
umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan university of medical sciences
Full name of responsible person
Maryam Davoudi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Besat hospital
City
Hamadan
Postal code
Phone
+98 81 1264 0030
Fax
+98 81 1265 1515
Email
davoudi@umsha.ac.ir; mdavoudi10@yahoo.com
Web page address
umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamadan university of medical sciences
Full name of responsible person
Maryam Davoudi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Besat hospital
City
Hamadan
Postal code
Phone
+98 81 1246 0030
Fax
+98 81 1265 1515
Email
davoudi@umsha.ac.ir; mdavoudi10@yahoo.com
Web page address
umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)