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Post-operative Analgesic efficacy of ultrasound-guided sub costal transversus abdominis plane(TAP) block for laparoscopic Cholecystectomy

Protocol summary

Study aim
Determination of TAP block effects on postoperative pain control,opioids consumption rate ,nausea and vomiting incidence
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
This study will be performed on 60 ASA class I-II patients , the ages of 20--65 years .After obtaining of an informed consent ,they will be allocated to two groups by block random sampling.
Participants/Inclusion and exclusion criteria
Incclusion criteria:20-65 years patients scheduled elective laparascopic cholecystectomy Exclution criteria:patient refusal,allergy to local anesthetics,coagulopathy,BMI>35,previous abdominal surgery,pregnancy,addiction
Intervention groups
TAP GROUP:At the end of the surgery,under ultrasound guidance, 0.2% bupivacaine 20 ml will be injected between rectus abdominis and transverse abdominis at subcostal region.This block will be done bilaterally. CONTROL GROUP:The transverse abdominal plane block will not be done. IN both groups,the pain severity by visual analogue scale(VAS),nausea and vomiting incidence,need to mepridine and metocloparmide will be evaluated. Time frame of assessments :during recovery room stay,at 4h,8h,12h and 24h.All patients will be evaluated before surgery and also will be told them about the VAS,where 0=no pain and 10=worst imaginable pain.In both groups ,all patients and the evaluating person will not awared of being or not being intervention.For nausea :0=none,1=mild,2=moderate,3=sever
Main outcome variables
severity of pain,opioid consumption ,nausea and vomiting incidence during recovery and up to 24 hours after surgery

General information

Reason for update
Acronym
TAP
IRCT registration information
IRCT registration number: IRCT20180325039148N1
Registration date: 2018-05-17, 1397/02/27
Registration timing: prospective

Last update: 2018-05-17, 1397/02/27
Update count: 0
Registration date
2018-05-17, 1397/02/27
Registrant information
Name
Saeed Jalili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3313 0001
Email address
jalilis45@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-20, 1397/03/30
Expected recruitment end date
2018-09-21, 1397/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Post-operative Analgesic efficacy of ultrasound-guided sub costal transversus abdominis plane(TAP) block for laparoscopic Cholecystectomy
Public title
Effect of abdominal wall block on post cholecystectomy pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients within 20-60 years undregoing laparoscopic Cholecystectomy Body Mass Index below 30
Exclusion criteria:
pregnancy Allergy to local anesthetics sepsis Addiction
Age
From 20 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Random blocks will be performed for this trial.Each block has 4 samples,two TAP block and two control with different orders.
Blinding (investigator's opinion)
Double blinded
Blinding description
All patients(control and intervention groups) after giving necessary explanations will be enrolling in abdominal block group or control group .The anesthetist who is responsible for evaluating of outcomes ,will be blinded about doing or not doing of abdominal plane block.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Gavazanng Blvd.,Mousavi Hosp.
City
Zanjan
Province
Zanjan
Postal code
4513956183
Approval date
2018-03-06, 1396/12/15
Ethics committee reference number
IR.ZUMS.REC.1396.322

Health conditions studied

1

Description of health condition studied
Sub costal Transverus Abdominal Plane Block
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
pain rating in Visual Analogue Scale
Timepoint
During recovery,At 4h,8h,12h,24h after surgery
Method of measurement
Visual Analogue Scale questionnaire

2

Description
Post operative need to opioid analgesic
Timepoint
During recovery,At 4h,8h,12h,24h after surgery
Method of measurement
Opioid amounts(mg)

3

Description
post operative Nausea and vomiting
Timepoint
During recovery,At 4h,8h,12h,24h after surgery
Method of measurement
Categorical Scoring System for nausea

Secondary outcomes

1

Description
Need to postop analgesic
Timepoint
During recovery,At 4h,8h,12h,24h after surgery
Method of measurement
Analgesic amounts(mg)

Intervention groups

1

Description
Intervention group:This randomized study will be enrolled patients with American Society of Anesthesiologists (ASA) physical status I–II aged 18–65 years, undergoing laparoscopic cholecystectomy at Zanjan mousavi Research and Training Hospital.The operation will be done under General Anesthesia. TAP GROUP:At the end of the surgery,under ultrasound guidance, 0.2% bupivacaine 20 ml will be injected between rectus abdominis and transverse abdominis at subcostal region.This block will be done bilaterally. IN intervention and control groups,the pain severity by visual analogue scale(VAS),nausea and vomiting incidence,need to mepridine and metocloparmide will be evaluated. Time frame of assessments :during recovery room stay,at 4h,8h,12h and 24h.All patients will be evaluated before surgery and also will be told them about the VAS,where 0=no pain and 10=worst imaginable pain.In both groups ,all patients and the evaluating person will not awared of being or not being intervention.For nausea :0=none,1=mild,2=moderate,3=sever
Category
Treatment - Other

2

Description
Control group:There wont be any special intervention or TAP block.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mousavi Hospital
Full name of responsible person
Saeed Jalili
Street address
Gavazang Blvd.,Mosavi Hospital
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Fax
+98 24 3313 1203
Email
jalilis45@zums.ac.ir
Web page address
http://zums.ac.ir/index.php?slc_lang=fa&sid=19

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Shoghli Alireza
Street address
Gavazang Blvd.,Mousavi hospital
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Fax
+98 24 3313 1203
Email
jalilis45@zums.ac.ir
Web page address
http://zums.ac.ir/index.php?slc_lang=fa&sid=19
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Saeed Jalili
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Gavazang Blvd.,moosavi hospital
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0001
Fax
Email
jalilis45@zums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Saeed Jalili
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Gavazang Blvd.,moosavi hospital
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0001
Fax
Email
jalilis45@zums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Saeed Jalili
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Gavazang Blvd.,moosavi hospital
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0001
Fax
Email
jalilis45@zums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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