Protocol summary

Study aim
1- Determination of effect of Ketorolac and Morphine with Morphine alone in number needed to treat in postoperative pain management of obese patient undergoing gastric bypass surgery in Iranmehr hospital in 1396 2-Determination of effect of Ketorolac and Morphine with Morphine alone in pain score of 6th hour after surgery of obese patient undergoing gastric bypass surgery in Iranmehr hospital in 1396
Design
Sample size was 34 in each group due to Repeated Measure method (6 repeat) with G-Power statistical software. Type 1 error and statistical power was 0.05 and 95%. Participants are allocated in two groups by permuted block randomization method. Also Allocation concealment will be ensured, by assigning 5 digit code to participants in each group by a person who is not aware of hypothesis. Surgical and anesthetic plan was the same for two groups. Control group received patient control analgesia (PCA) with infusion of 0.8 mg morphine sulfate per hour and intervention group received PCA with infusion of 0.4 mg morphine sulfate plus 30 mg IV and 30 mg IM ketorolac and also 15 mg ketorolac IM each 6 hour. Pain in both group was evaluated by Visual Analogue Scale (VAS). At the time of entering ward, and 6, 12 and 24 hour after admission to ward VAS was measured. Dose of Acetaminophen and ondansetron used for each group also recorded.
Settings and conduct
This study was conducted in Iranmehr Hospital under supervision of anesthesiologist. In this study, due to intramuscular injection of ketorolac, participants and nurses in the operating room are not blinded. On the other hand data collector and outcome assessors will be blinded to the group of participants.
Participants/Inclusion and exclusion criteria
Inclusion Criteria BMI>40 BMI>35 with complications ASA I & II Exclusion Criteria ASA >III Any changes in anesthesia or surgical plan Any history of addiction or substance abuse Any history of allergic reaction to drugs using in the study
Intervention groups
Control group received patient control analgesia (PCA) with infusion of 0.8 mg morphine sulfate per hour and intervention group received PCA with infusion of 0.4 mg morphine sulfate plus 30 mg IV and 30 mg IM ketorolac and also 15 mg ketorolac IM each 6 hour. Both of them in addition to the described regiment, will receive 1 gr of acetaminophen intravascular each 12 hour.
Main outcome variables
Pain score by VAS score Number needed to treat

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171014036769N2
Registration date: 2018-02-20, 1396/12/01
Registration timing: registered_while_recruiting

Last update: 2018-02-20, 1396/12/01
Update count: 0
Registration date
2018-02-20, 1396/12/01
Registrant information
Name
Soodeh Tabashi
Name of organization / entity
Shahid Beheshti Medical University
Country
Iran (Islamic Republic of)
Phone
+98 21 8872 8251
Email address
soodeh.tabashi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti Medical University
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Title: Comparing The Effect Of Ketorolac and Morphine With Morphine Alone in Postoperative Pain Management of Obese Patient Undergoing Gastric Bypass Surgery.
Public title
Postoperative Pain Management of Obese Patient Undergoing Gastric Bypass Surgery.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Body Mass Index >40kg/m2 candidate for gastric bypass surgery Body mass Index > 35kg/m2 in addition to coexisting diseases such as diabetes, hypertension, renal disease, cardiovascular diseases ASA class : 1 or 2
Exclusion criteria:
reported Addiction to psychotropic drugs or substance abuse History of allergic reactions to drugs used in the study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
Participants are allocated in two groups by permuted block randomization method which the block size was assumed four. Also Allocation concealment will be ensured, by central telephone method and assigning 5 digit code to participants in each group by a person who is not aware of hypothesis.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, nurses in the operating room are not blinded. On the other hand data collector and outcome assessors will be blinded to the group of participants. Patient is blind to the group they are in.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of faculty of medicine, Shahid Beheshti Medical University
Street address
Shahid Beheshti University of medical sciences, Shahid Aarabi st., Yaman Ave., Shahid Chamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
19839-63113
Approval date
2017-02-14, 1395/11/26
Ethics committee reference number
IR.SBMU.MSP.REC.1395.541

Health conditions studied

1

Description of health condition studied
Post Operative Pain
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain

2

Description of health condition studied
Morbid Obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity

Primary outcomes

1

Description
VAS (Visual Analogue Scale) pain score
Timepoint
Immediately after the surgrey, 6 , 12 , 24 hours later and at the time of discharge
Method of measurement
Pain score questionnaire

Secondary outcomes

1

Description
Post Operative Nausea and Vomiting
Timepoint
0,6,12,24 hours after exiting recovery room
Method of measurement
questionnaire

2

Description
Length of Stay
Timepoint
at the time of discharge
Method of measurement
questionnaire

Intervention groups

1

Description
Intervention group: patients will receive PCA infusion of 0.4 mg morphine sulfate per hour and Apotel 1 gram intravenously every 12 hours plus 30 mg IV and 30 mg IM ketorolac and also 15 mg ketorolac IV every 6 hours. If VAS score is more than 49mm patient will receive Apotel 1 gram intravenous with maximum dose of 4 gram daily.If the patient feel nausea, 4 mg intravenous Ondansetrone will be administered.
Category
Treatment - Drugs

2

Description
Control group: patients in control group wil receive patient control analgesia (PCA) with infusion of 0.8 mg morphine sulfate per hour and Apotel 1 gram intravenous each 12 hours at the time they discharge from the recovery ward.If VAS score is more than 49mm patient will receive Apotel 1 gram intravenous with maximum dose of 4 gram daily.If the patient feel nauseated, 4 mg intravenous Ondansetrone will be administered.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Iran Mehr Hospital
Full name of responsible person
Dr Noor Mohammad Arefian
Street address
Gholhak, Shariati Ave. , Tehran
City
Tehran
Province
Tehran
Postal code
1949913413
Phone
+98 21 2200 9071
Email
soodeh.tabashi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti Medical University
Full name of responsible person
Dr Noor Mohammad Arefian
Street address
Erabi St., Yaman St., Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Email
info@sbmu.ac.ir
Web page address
http://msp.sbmu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti Medical University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti Medical University
Full name of responsible person
Dr Soodeh Tabashi
Position
Resident of Anesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Street address
Erabi St., Yaman St., Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2387 2592
Fax
Email
school.of.medicine@sbmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti Medical University
Full name of responsible person
Dr Noor Mohammad Arefian
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Street address
Erabi St., Yaman St., Chamran highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2274 9201
Fax
Email
narefian@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti Medical University
Full name of responsible person
Soodeh Tabashi
Position
Resident of Anesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Street address
No. 26, 6th alley, Vozara St.
City
Tehran
Province
Tehran
Postal code
1511738843
Phone
+98 912 205 6971
Fax
Email
soodeh.tabashi@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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