1. Home
  2. Approved trials
  3. » فارسی

Comparison of intraperitoneal saline with bupivacaine in addition pulmonary recruitment maneuver on post-laparoscopic shoulder pain; a randomized double-blind clinical trial

Protocol summary

Study aim
Comparison of Saline with Bupivacaine intraperitoneally with Pulmonary Recurrence maneuver on shoulder pain after laparoscopy; A randomized double-blind clinical trial study
Design
Randomized clinical trial in individuals aged 20 to 60 years and with inclusion criteria, candidate cholecystectomy laparoscopic be carried out which has randomly divided into two groups of 40 people using block Rndvmyzyshn were divided .
Settings and conduct
Anesthesia will be the same in all patients and laparoscopic surgery was performed by a skilled surgeon In the first group, the end of the operation, in addition to the usual method of venting CO2, normal saline solution heated to 20 cc per kg in supine position can be injected into the abdominal cavity (13). In addition to the serum injection, a pulmonary maneuver was performed by an anesthesiologist. In the second group, at the beginning, starting with surgery, 50 cc of bupivacaine diluted solution will be injected into the abdomen 25/0 percent of the space. At the end of the operation, a pulmonary recruitment maneuver was performed. Evaluation of shoulder pain and wound pain by visual analog scale pain gauges at time intervals: recovery, 12, 24 and 48 hours after surgery.
Participants/Inclusion and exclusion criteria
Age between 20 and 60 years, grade 1 and 2 physical classification according to the American Anesthesia Association Guideline, no drug addiction, no chronic pain, no anesthesia, history of disease and surgery in Shoulder and chest area and no abdominal surgery, women are not pregnant, no neurological and mental illness
Intervention groups
Group two intervention: Saline with Pulmonary Recurrence maneuver and Bupivacaine intraperitoneally with Pulmonary Recurrence maneuver
Main outcome variables
the pain Intraperitoneal injection of saline and bupivacaine Pulmonary recruitment maneuver

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190113042346N2
Registration date: 2020-12-18, 1399/09/28
Registration timing: prospective

Last update: 2020-12-18, 1399/09/28
Update count: 0
Registration date
2020-12-18, 1399/09/28
Registrant information
Name
hosnieh raufiyan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3657 6830
Email address
h.raufyian@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-20, 1399/11/01
Expected recruitment end date
2021-05-22, 1400/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intraperitoneal saline with bupivacaine in addition pulmonary recruitment maneuver on post-laparoscopic shoulder pain; a randomized double-blind clinical trial
Public title
Comparison of intraperitoneal saline with bupivacaine in addition pulmonary recruitment maneuver on post-laparoscopic shoulder pain; a randomized double-blind clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20 and 60 years Grade 1 and 2 physical classification according to the American Anesthesia Association Guideline No drug addiction No chronic pain Lack of sensitivity to anesthetics History of disease and surgery in Shoulder and chest area and no abdominal surgery Women are not pregnant No neurological and mental illness
Exclusion criteria:
Conversion of laparoscopic surgery to laparotomy Creating any clinical condition in which pulmonary maneuver can not be performed Any complication that increases postoperative pain
Age
From 20 years old to 60 years old
Gender
Both
Phase
1-2
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling in this study will be that first in order to enter patients in the study will be non-random sampling of the type "available" and then divide them into two intervention groups as randomized blocking using a web-based system Random blocking will be done at www.randomization.com
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and pain assessor did not know the type of intervention
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of North Khorasan University of Medical Sciences
Street address
Shahriar Street
City
Bojnourd
Province
North Khorasan
Postal code
9678694176
Approval date
2020-08-26, 1399/06/05
Ethics committee reference number
IR.NKUMS.REC.1399.048

Health conditions studied

1

Description of health condition studied
Shoulder Pain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain
Timepoint
Recovery, 12, 24 and 48 hours after surgery
Method of measurement
Pain assessment based on Visual Analog Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Saline group with Pulmonary Recruitment maneuver
Category
Treatment - Other

2

Description
Intervention group2 : Bupivacaine with Pulmonary Recruitment maneuver
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Ali Hospital
Full name of responsible person
Javad Shahinfar
Street address
Street
City
Bojnourd
Province
North Khorasan
Postal code
9417694734
Phone
+98 58 3229 7010
Email
h.raufyian@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Deputy of Research and Technology of North Khorasan University of Medical Sciences
Street address
Shahriar Street
City
bojnourd
Province
North Khorasan
Postal code
9678694176
Phone
+98 58 3229 7182
Email
research@nkums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bojnourd 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
Bojnourd University of Medical Sciences
Full name of responsible person
Javad Shahin far
Position
Faculty member
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahriar Street
City
Bojnourd
Province
North Khorasan
Postal code
9678694176
Phone
009832297096
Email
h.raufyian@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Hosnieh Raufiyan
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahriar Street
City
Bojnourd
Province
North Khorasan
Postal code
9678694176
Phone
+98 58 3229 7096
Email
h.raufyian@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Hosnieh Raufiyan
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahriar Street
City
Bojnourd
Province
North Khorasan
Postal code
9678694176
Phone
+98 58 3229 7096
Email
h.raufyian@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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data will be published after collection
When the data will become available and for how long
6 months after publication
To whom data/document is available
Researchers
Under which criteria data/document could be used
It can be used if citation is mentioned
From where data/document is obtainable
Scientific Officer
What processes are involved for a request to access data/document
Send E-mail
Comments
Loading...