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A clinical trial to compare the effectiveness of normal saline with diclofenac suppository and bupivacaine on pain relief following laparoscopic herniorrhaphy surgery

Protocol summary

Study aim
A clinical trial to compare the effectiveness of normal saline with diclofenac suppository and bupivacaine on pain relief following laparoscopic herniorrhaphy surgery
Design
Forty patients who were candidates for laparoscopic herniorrhaphy, clinical trial with a control group, community-based and pragmatic, parallel groups, double-blind, randomized using table of random numbers
Settings and conduct
Patients candidate for laparoscopic herniorrhaphy at the Rasoul Akram Hospital, Tehran, were chosen. In this double-blind study, the participants and responsible for data collection are blinded to the type of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The patients with ASA class one or two, who are candidate for laparoscopic herniorrhaphy. Exclusion criteria: Allergy to the drugs studied; history of hypertension; history of uncontrolled diabetes; history of cardiovascular diseases; history of renal failure, history of cirrhosis; history of smoking or drug abuse; pregnant women.
Intervention groups
The control group are receiving 500 cc normal saline after surgery. The intervention group one are receiving 50 mg diclofenac suppository per 8 hours after surgery. The intervention group two are receiving 0.25% bupivacaine dissolved in 100 ml of physiologic serum after surgery.
Main outcome variables
Evaluation and comparison of pain relief based on the visual analog scale (VAS) 3, 8, 12, 16, 20 and 24 hours after the intervention between three studies groups.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180522039782N2
Registration date: 2018-10-14, 1397/07/22
Registration timing: prospective

Last update: 2018-10-14, 1397/07/22
Update count: 0
Registration date
2018-10-14, 1397/07/22
Registrant information
Name
Behnood Farazmand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8842 9230
Email address
farazmand.b@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-11, 1397/09/20
Expected recruitment end date
2019-12-11, 1398/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to compare the effectiveness of normal saline with diclofenac suppository and bupivacaine on pain relief following laparoscopic herniorrhaphy surgery
Public title
The effective of diclofenac suppository and bupivacaine on pain relief following laparoscopic herniorrhaphy surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patients with ASA class one or two, who are candidate for laparoscopic herniorrhaphy
Exclusion criteria:
Allergy to the drugs studied, , , , , , and ; History of hypertension History of uncontrolled diabetes History of cardiovascular diseases History of renal failure History of cirrhosis History of smoking or drug abuse pregnant women
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Sixty patients who are candidates for laparoscopic herniorrhaphy are randomly allocated using table of random numbers based on computer programs. To this end, a code is allocated to each of the participants to be assigned into one of the three groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients candidate for laparoscopic herniorrhaphy at the Rasoul Akram Hospital, Tehran, were chosen. In this double-blind study, the participants and responsible for data collection are blinded to the type of treatment.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-03-08, 1396/12/17
Ethics committee reference number
IR.IUMS.FMD.REC 1396.9311245006

Health conditions studied

1

Description of health condition studied
laparoscopic herniorrhaphy
ICD-10 code
K46
ICD-10 code description
Unspecified abdominal hernia

Primary outcomes

1

Description
pain relief
Timepoint
3, 8, 12, 16, 20 and 24 hours after the intervention
Method of measurement
based on the visual analog scale (VAS)

Secondary outcomes

empty

Intervention groups

1

Description
Control group: Patients are receiving 500 cc normal saline after surgery.
Category
Treatment - Drugs

2

Description
Intervention group: Patients are receiving 50 mg diclofenac suppository per 8 hours after surgery.
Category
Treatment - Drugs

3

Description
Intervention group: Patients are receiving 0.25% bupivacaine dissolved in 100 ml of physiologic serum after surgery.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasoul Akram Hospital
Full name of responsible person
Behnood Farazmand
Street address
Rasoul Akram Hospital, Niyayesh Street, Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 8842 9230
Email
behnoood@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Kazem Malakoti
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8842 9230
Email
PR@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
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
Iran University of Medical Sciences
Full name of responsible person
Behnood Farazmand
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8842 9230
Email
behnoood@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Behnood Farazmand
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8842 9230
Email
behnoood@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Behnood Farazmand
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8842 9230
Email
behnoood@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not 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
Title and more details about the data/document
The total data to be included are the primary and secondary effects to be shared.
When the data will become available and for how long
6 months after printing results.
To whom data/document is available
Our data will only be available to researchers working in science center and university.
Under which criteria data/document could be used
Our data will be available for scholars working in science center and university.
From where data/document is obtainable
Behnood Farazmand provides the analysis code to the applicants via email: behnoood@gmail.com
What processes are involved for a request to access data/document
Data collection was done for 10 months, data were collected one month, statistical analysis of one month, information dissemination as a article six months.
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