Comparison of the effects of intravenous ibuprofen and pump pain with pump pain alone on postoperative pain in patients undergoing open appendectomy and inguinal hernia: a clinical trial
This double-blind randomized clinical trial is conducted on patient who are candidate for open appendectomy or inguinal hernioplasty in Fatemi Hospital of Ardabil in 2016. In this study both patients and researchers will be blinded and medications will be put in two packets labeled 1 and 2 and each patient will be given one randomly. The medications will be injected by the research collaborator. 60 patients aged 20-60 years who are candidate for open appendectomy or inguinal hernioplasty are included in this study and exclusion criteria includes patients with underlying disease, gastrointestinal disease, opioid or NSAIDs’ allergy or drug-addicted. Patients are randomly divided into two groups; first group receives 400 mg intravenous ibuprofen in the recovery and at 6, 12, and 18 hours after surgery in addition to 15 ug/ml fentanyl pump. Second group only receives 15 ug/ml fentanyl pump. Pain pump acts with a lockout time of 15 minutes with 1 ml bolus injection with 15ug/ml concentration. For pain management with this pump, 30 cc fentanyl diluted in 70 ml normal saline (15 ug/ml) and all patients can use the pump on pain onset. In the two study groups, VAS will be measured in hours 1, 6, 12, 18, and 24 and opioid consumption and nausea and vomiting will be compared in these groups
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201608284131N3
Registration date:2016-09-17, 1395/06/27
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-09-17, 1395/06/27
Registrant information
Name
َAfshan Sharghi
Name of organization / entity
Ardabil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 1551 2012
Email address
a.sharghi@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ardabil University of Medical Sciences
Expected recruitment start date
2016-09-20, 1395/06/30
Expected recruitment end date
2016-11-20, 1395/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of intravenous ibuprofen and pump pain with pump pain alone on postoperative pain in patients undergoing open appendectomy and inguinal hernia: a clinical trial
Public title
Ibuprofen effect of postoperative pain management
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients aged 20-60 years; candidate for open appendectomy or inguinal hernioplasty surgery.
Exclusion criteria: underlying disease; gastrointestinal disease; opioid allergy; NSAID allergy; drug addiction, refusal of patients to consent for participating in the study
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
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
The study will be performed as a randomized, double-blind, controlled clinical trial using closed envelope method
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Ardabil University Of Medical Science
Street address
Daneshgah St، Ardabil
City
Ardabil
Postal code
Approval date
2016-05-04, 1395/02/15
Ethics committee reference number
IR.ARUMS.REC.1395.4
Health conditions studied
1
Description of health condition studied
Open appendectomy
ICD-10 code
K35.8, K36
ICD-10 code description
Acute appendicitis, other and unspecified, Other appendicitis
2
Description of health condition studied
inguinal hernia
ICD-10 code
K40.9
ICD-10 code description
Unilateral or unspecified inguinal hernia, without obstruction or gangrene
Primary outcomes
1
Description
Pain
Timepoint
1, 6, 12, 18, and 24 hours after surgery
Method of measurement
Visual Analog Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 400 mg ibuprofen intravenous injection in recovery which will be repeated on hours 1, 6, 12, 18 after surgery in addition to 15 ug/ml fentanyl pain pump
Category
Treatment - Drugs
2
Description
Control group: bolus 15 ug/ml fentanyl pain pump
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ardabil Fatemi Hospital
Full name of responsible person
Dr. AmirAhmad Arabzadeh
Street address
Ardabil
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research Of Ardabil University Of Medical Sciences
Full name of responsible person
Dr. Akbar Pirzadeh
Street address
Daneshgah st, Ardabil
City
Ardabil
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 Of Ardabil 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
Ardabil University Of Medical Sciences
Full name of responsible person
Dr. AmirAhmad Arabzadeh
Position
General Surgeon
Other areas of specialty/work
Street address
Ardabil
City
Ardabil
Postal code
Phone
+98 45 3351 3777
Fax
Email
a.sharghi@arums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University Of Medical Sciences
Full name of responsible person
Dr. Afshan Sharghi
Position
Social Medicine Specialist
Other areas of specialty/work
Street address
Ardabil
City
Ardabil
Postal code
Phone
+98 45 3351 3777
Fax
Email
a.sharghi@arums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University Of Medical Sciences
Full name of responsible person
Dr. Afshan Sharghi
Position
Social Medicine Specialist
Other areas of specialty/work
Street address
Danesh St, Ardabil
City
Ardabil
Postal code
Phone
+98 45 3351 3777
Fax
Email
a.sharghi@arums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)