Evaluation of the efficacy and safety of oral pregabalin on post Lichtenstein herniorrhaphy pain relief in comparison with control group, Mousavi Hospital, Zanjan, 2014-2015
Aim: Evaluation of the efficacy and safety of pregabalin in post herniorrhaphy surgery pain relief.
Major inclusion criteria: male patient; unilateral hernia; elective surgery.
Major exclusion criteria: emergency surgery; significant medical and drug history that may interfere with outcomes.
Sample size and population: Sixty male patients with unilateral inguinal hernia who refer to Zanjan Ayatollah Mousavi hospital.
Intervention and time: The patients are randomly allocated to two groups: The pregabalin group receive single-dose 300 mg oral pregabalin 2 h before and 150 mg pregabalin 12 and 24 h after surgery in addition to routine post operative medication, and the control group just receive routine medication. The operations are performed by the same surgeon with the same technique.
Main outcomes: Postoperative pain that is evaluated during walking and lying with a visual analogue scale (VAS) 12 h, 24 h, 3 and 7 days after surgery. Pethidine consumption and the adverse effects of pregabalin are also evaluated.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2015041821817N1
Registration date:2015-07-11, 1394/04/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-07-11, 1394/04/20
Registrant information
Name
Vahid Salehi
Name of organization / entity
Zanjan University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 24 3313 0001
Email address
zums90vhds@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Zanjan University of Medical Sciences
Expected recruitment start date
2014-10-02, 1393/07/10
Expected recruitment end date
2015-08-06, 1394/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy and safety of oral pregabalin on post Lichtenstein herniorrhaphy pain relief in comparison with control group, Mousavi Hospital, Zanjan, 2014-2015
Public title
The effect of oral Pregabalin on post herniorrhaphy pain relief
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Male patients over 18 years old; unilateral inguinal hernia; elective surgery.
Exclusion criteria: Emergency surgery; incarceration; simultaneous other operations; history of diabetes mellitus; peptic ulcer; gastritis; renal failure; neuropsychiatric disorders; opium abuse; neuropsychiatric medications; presenting drug adverse effects.
Age
From 18 years old
Gender
Male
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)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zanjan University of Medical Siences
Street address
Azadi street, Zanjan
City
Zanjan
Postal code
Approval date
2014-10-02, 1393/07/10
Ethics committee reference number
ZUMS.REC.1392.117
Health conditions studied
1
Description of health condition studied
Inguinal hernia
ICD-10 code
K40.9
ICD-10 code description
Unilateral or unspecified femoral hernia, without obstruction or gangrene
Primary outcomes
1
Description
Pain
Timepoint
12 and 24h, 3 and 7 days after operation
Method of measurement
Visual Analogue Scale
2
Description
Pethidine consumption
Timepoint
First 24 h post operation, total dosages during admission
Method of measurement
The number of dosages as patient request (according to his weight)
3
Description
Oral analgesic (gellofen) consumption
Timepoint
Till 3 rd and till 7 th dad post operation
Method of measurement
The count of capsuls consumption
Secondary outcomes
1
Description
Drug adverse effects
Timepoint
12 and 24 h post operation, 3 and 7 days post op
Method of measurement
Filling the data collecting form
Intervention groups
1
Description
Intervention group: receive single-dose 300 mg oral pregabalin 2 h before and 150 mg pregabalin 12 and 24 h after surgery in addition to 1 mg per kg of pethidine PRN.
Category
Treatment - Drugs
2
Description
Control group: just receive 1 mg per kg of pethidine PRN.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Mousavi Hospital
Full name of responsible person
Vahid Salehi
Street address
General surgery ward, Ayatollah Mousavi Hospital
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Siences
Full name of responsible person
Dr Mohammad Masoud Vakili
Street address
Vice chancellor for research, University of Medical Sciences, Azadi Blvd, Zanjan
City
Zanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Siences
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
Zanjan University of Medical Siences
Full name of responsible person
Vahid Salehi
Position
General surgery resident
Other areas of specialty/work
Street address
General surgery ward, Mousavi Hospital
City
Zanjan
Postal code
Phone
+98 24 3313 0001
Fax
Email
sums78_vhds@yahoo.com; sums78vhds@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Siences
Full name of responsible person
Dr Mohammad Hossein Moghimi, Dr Vahid Salehi
Position
General surgery resident
Other areas of specialty/work
Street address
General surgery ward, Ayatollah Mousavi Hospital
City
Zanjan
Postal code
Phone
+98 24 3313 0001
Fax
+98 24 3313 1431
Email
sums78vhds@gmail.com; sums78_vhds@yahoomail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Siences
Full name of responsible person
Vahid Salehi
Position
General surgery resident
Other areas of specialty/work
Street address
General surgery ward, Ayatollah Mousavi Hospital
City
Zanjan
Postal code
Phone
+98 24 3313 0001
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)