Protocol summary

Study aim
Comparison of Erector Spine Block and External Oblique Intercostal Block with Ultrasonography Guided to pain control after laparoscopic cholecystectomy surgery a clinical trial
Design
Clinical trial, parallel groups, double-blind, randomized, on 28 patients. In order to randomize, the block randomization method will be used.
Settings and conduct
Patient candidates for laparoscopic cholecystectomy surgery referring to Firouzgar Hospital in Tehran will be included in the study. Patients will be randomly divided into 2 groups based on blocks of 4. Patients, responsible for data collection, analysis and outcome assessment will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patient candidates for laparoscopic cholecystectomy surgery, The age range from 20 to 60 years. Exclusion criteria: Coagulation disorders, Neurological disorders.
Intervention groups
Intervention group 1: In the erector spinae block group, the patient will be placed in the lateral position, then by examining the injection site and monitoring and necessary preparation, with the help of ultrasound guidance, the correct injection site on the transverse process of the 6th vertebra will be determined and inserted under ultrasound guidance. After reaching the site, after effective aspiration, 20 ml of 0.2% rupivacaine will be injected. Intervention Group 2: In the external oblique intercostal block group, the patient will be placed in the supine position, then, by examining the injection site, monitoring, and necessary preparation, with the help of ultrasound guidance, the correct injection site will be determined in the mid-axillary line near the 6-7th rib, and the patient will be inserted under ultrasound guidance. After reaching the site, after effective aspiration, 20 ml of 0.2% rupivacaine will be injected.
Main outcome variables
Pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230518058225N9
Registration date: 2025-02-22, 1403/12/04
Registration timing: prospective

Last update: 2025-02-22, 1403/12/04
Update count: 0
Registration date
2025-02-22, 1403/12/04
Registrant information
Name
Anahita Sadri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 2543
Email address
sadri.anahita@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-03-10, 1403/12/20
Expected recruitment end date
2025-09-11, 1404/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Erector Spine Block and External Oblique Intercostal Block with Ultrasonography Guided to pain control after laparoscopic cholecystectomy surgery a clinical trial
Public title
Effect of Erector Spine Block and External Oblique Intercostal Block with Ultrasonography Guided to pain control
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient candidates for laparoscopic cholecystectomy surgery The age range from 20 to 60 years
Exclusion criteria:
Severe pulmonary disease Neurological disorders
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 28
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided into 2 groups. The randomization tool will randomize the table of numbers. Block randomization method will be used for randomization. Block randomization is for the purpose of making sure that exactly equal number of participants enter the study groups. The advantages of block randomization are that the balance of the number of participants in each group is guaranteed. For this purpose, 4 blocks will be formed and in each block 2 people from intervention group and 2 people will be placed in the control group. A total of 7 blocks will be considered to reach the sample size. Blocks contain numbers, numbers represent study groups. Their order will be determined by the statistician from the beginning. In order to hide the random allocation, opaque envelopes sealed with a random sequence will be used. In this method, each of the generated random sequences will be recorded on a card and the cards will be placed in the envelopes in order. became. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of registration of participants, based on the order of entry of qualified participants into the study, one of the envelopes will be opened in order and the assigned group of that participant will be revealed.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients will be aware that they will be randomly assigned to one of the two study groups, but will not know which method will be provided in that group. Patients will be assigned to one of two groups using a random number table. The person in charge of data collection, the analyst and the outcome evaluator will collect and analyze the information based on groups 1 and 2 and will not know the type of treatment in the groups and will be kept blind.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Faculty of Medicine - Iran University of Medical Sciences (Research Ethics Committee)
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2024-09-29, 1403/07/08
Ethics committee reference number
IR.IUMS.FMD.REC.1403.305

Health conditions studied

1

Description of health condition studied
Pain
ICD-10 code
G89
ICD-10 code description
Pain, not elsewhere classified

Primary outcomes

1

Description
Pain
Timepoint
at 0, 2, 6, 12, 24 hours after surgery
Method of measurement
Numerical pain rating scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: In the erector spinae block group, the patient will be placed in the lateral position, then by examining the injection site and monitoring and necessary preparation, with the help of ultrasound guidance, the correct injection site on the transverse process of the 6th vertebra will be determined and inserted under ultrasound guidance. After reaching the site, after effective aspiration, 20 ml of 0.2% rupivacaine (manufacturer: Varian Pharmed) will be injected.
Category
Treatment - Other

2

Description
Intervention Group 2: In the external oblique intercostal block group, the patient will be placed in the supine position, then, by examining the injection site, monitoring, and necessary preparation, with the help of ultrasound guidance, the correct injection site will be determined in the mid-axillary line near the 6-7th rib, and the patient will be inserted under ultrasound guidance. After reaching the site, after effective aspiration, 20 ml of 0.2% rupivacaine (manufacturer: Varian Pharmed) will be injected.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Firouzgar hospital
Full name of responsible person
Nafiseh Tavakoli
Street address
Beh Afarin Ave, Vali Asr Sq.
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1600
Email
h_firoozgar@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Majid Safa
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
research@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
Nafiseh Tavakoli
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Rasoul-Akram Hospital, Niayesh St., Sattarkahn Ave
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2222
Email
ntvk1356@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Soudabeh Jalali Motlagh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Beh Afarin Ave, Vali Asr Sq
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1600
Email
djalalimotlagh.s@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Nafiseh Tavakoli
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Rasoul-Akram Hospital, Niayesh St., Sattarkahn Ave
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2222
Email
ntvk1356@gmail.com

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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