Protocol summary

Study aim
Using the results and information of this study to control the patient's pain after removing the chest tube
Design
Randomized, superiority, parallel group trial with double blinded outcome assessment. Randomization is analyzed with SPSS software. there will be 50 smaples from patients that refer to goletan or imam hospital of ahvaz.
Settings and conduct
The study will be conducted on the patients who visited the ICU center of Golestan and Imam Ahvaz hospitals in 2011-02. During the study, the anesthesia resident prepares the medicine and the fellowship doctor injects the pain medicine to the patients. The responsible student completes the relevant questionnaire. Patients, anesthesiology resident, pain fellowship doctor and student do not know which drug is injected into which patient.
Participants/Inclusion and exclusion criteria
Admission: age 18 to 60 years, physical condition, body mass index less than 40 kg/m2, no history of drug or alcohol abuse, no pregnancy or breastfeeding, no history of coagulopathy or use of anticoagulants, mutation fraction above 30%, no history of block cardiac conduction, consciousness level above 14, no hepatitis, no history of psychiatric disease No need for complementary renal treatment, no neuropathy Failure to enter: sensitivity to the study drugs and unwillingness of patients to cooperate
Intervention groups
In both groups, ropivacaine is stable at 0.4 cc/kg of 0.2% solution. In group D1, 0.5 micrograms/kg of dexmedetomidine of body weight and in group D2, 1 microgram/kg of dexmedetomidine of body weight was added to the ropivacaine solution and injected according to the mentioned method.
Main outcome variables
groups of study,pain score, heart rate, systolic blood pressure, diastolic blood pressure, amount of narcotic drug use, oxygen saturation, duration of walking, duration of stay in ICU, time

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230213057405N1
Registration date: 2023-03-14, 1401/12/23
Registration timing: prospective

Last update: 2023-03-14, 1401/12/23
Update count: 0
Registration date
2023-03-14, 1401/12/23
Registrant information
Name
Danial jazayeri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 224 0138
Email address
jazayeri.sd@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2023-11-22, 1402/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of serratus anterior plane block with different dose of dexmedetomidine for patients with tube thoracostomy
Public title
The efficacy of serratus anterior plane block with different dose of dexmedetomidine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient consent to enter the study physical condition class I-II according to the standards of the Association of Anesthesiologists body mass index (BMI) less than 40 kg/m2 no pregnancy or breastfeeding no history of coagulopathy or the use of anticoagulants Ejection fraction higher than 30%, no history of conductive heart block (except for first degree heart block and controlled atrial fibrillation) the patient's level of consciousness should be above 14 no acute or chronic hepatitis no history of psychiatric disease no need for complementary Renal treatment or history of kidney failure and no neuropathy no history of drug or alcohol abuse
Exclusion criteria:
Allergy to the studied drugs unwillingness of patients to cooperate
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will divide into two groups with simple randomization. in order to randomization, two groups of closed envelope will be given to them. one group is D1 and another one is D2. number of two groups is equal.the patient picks up an envelope randomly and enters at his/her group. anesthesiology resident will prepare drugs and trial will be operated double blinded.
Blinding (investigator's opinion)
Double blinded
Blinding description
in this trial, anesthesiology resident will prepare the drug and anesthesiologist doctor(fellowship of pain) will insert the drug. medial intern fill the questionnaire. the patients, anesthesiology resident, anesthesiologist doctor and medial intern will not know which drug is given to which patient. so, the trial will be double_blinded.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee in Golestan Hospital Research
Street address
Farvardin Street, Golestan
City
ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Approval date
2022-12-13, 1401/09/22
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1401.158

Health conditions studied

1

Description of health condition studied
pain in patients with tube thoracostomy
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Study groups, pain score, heart rate, systolic blood pressure, diastolic blood pressure, amount of narcotic drug use, oxygen saturation, duration of walking, duration of stay in ICU
Timepoint
nominal, distance, relative, ratio (in mm Hg), ratio (in mm Hg), ratio (in mg/k), ratio (in percentage), ratio (in minutes), ratio (in minutes)
Method of measurement
According to the dose of dexmedetomidine, they are divided into two groups, 0.5 and 1. Based on the criteria, VNS describes the pain between numbers and 10, the number of heartbeats in one minute, systolic blood pressure measured by a sphygmomanometer, diastolic blood pressure measured by a sphygmomanometer, the amount of drug use. Narcotics to control the patient's pain, oxygen saturation percentage using pulse oximeter, time (using clock measurement), time (using clock measurement)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: group one that get 0.5 microgram per kg dexmedetomidine
Category
Treatment - Drugs

2

Description
Intervention group: group two that get 1 microgram per kg dexmedetomidine
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Kamran Mahmoodi
Street address
24 meter street
City
AHVAZ
Province
Khouzestan
Postal code
۶۱۹۳۶۷۳۱۶۶
Phone
+98 61 3311 0000
Fax
Email
himam@ajums.ac.ir
Web page address

2

Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Kamran Mahmoodi
Street address
Golestan - Farvardin Boulevard - in front of Iqbal Street
City
ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3320 4501
Fax
+98 61 3320 4516
Email
golestanhospital@ajums.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoosh Zakerkish
Street address
Farvardin Street, Golestan
City
ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3311 0000
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Kamran Mahmoodi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Farvardin Street, Golestan
City
ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3311 0000
Email
mahmoudi-k@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Kamran Mahmoodi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Farvardin Street, Golestan
City
ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3311 0000
Email
mahmoudi-k@ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Kamran Mahmoodi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Farvardin Street, Golestan
City
ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3311 0000
Email
mahmoudi-k@ajums.ac.ir

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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