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Evaluation of the palliative efficacy of adding calcitonin to ropivacaine in subcostal transverse abdominal plane (STAP) block for laparoscopic cholecystectomy

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History
# Registration date Revision Id
2 2026-08-27, 1405/06/05 394409
1 2025-04-08, 1404/01/19 335510
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  • Protocol summary

    کارآزمایی بالینی دارای 2 گروه، با گروه های موازی، سه سویه کور ، تصادفی شده، فاز 3 بر روی 36 بیمار. برای تصادفی سازی از روش تصادفی ساده (simple randomization) به صورت اﺳﺘﻔﺎده از ﺟﺪول اﻋﺪاد ﺗﺼﺎدﻓﯽ استفاده می شود.
    کارآزمایی بالینی دارای 2 گروه، با گروه های موازی، سه سویه کور، تصادفی شده، فاز 3 بر روی 36 بیمار. برای تصادفی سازی از روش تصادفی ساده (simple randomization) به صورت اﺳﺘﻔﺎده از ﺟﺪول اﻋﺪاد ﺗﺼﺎدﻓﯽ استفاده می شود.
    Mental health, adequate understanding and awareness of the patient and providing informed consent for all laparoscopic cholecystectomy surgeries
    Inclusion criteria: Mental health, adequate understanding and awareness of the patient and providing informed consent for all laparoscopic cholecystectomy surgeries
    سلامت عقلی , فهم و شعور کافی بیمار و ارائه رضایت آگاهانه کلیه اعمال جراحی کوله سیستکتمی لاپراسکوپیک
    شرایط ورود: سلامت عقلی، فهم و شعور کافی بیمار و ارائه رضایت آگاهانه کلیه اعمال جراحی کوله سیستکتمی لاپراسکوپیک

  • General information

    empty
    36
    empty
    2025-04-20, 1404/01/31
    empty
    2026-05-21, 1405/02/31
    empty
    Recruitment has been completed, so the actual recruitment dates were updated. The VAS assessment time points were updated in accordance with the ethics-approved protocol, and the 4-hour time point was removed. It had been entered mistakenly in the initial registration.
    empty
    نمونه گیری تکمیل شده است؛ بنابراین تاریخ‌های واقعیِ فرایند به‌روزرسانی شدند. ساعت های بررسی VAS مطابق پروپوزالی که کد اخلاق گرفته است ، بروزرسانی شد و ساعت 4 حذف شد. در ثبت اولیه ساعت 4 به اشتباه وارد شده بود.
    Analgesia for patients undergoing laparoscopic cholecystectomy with Ropivacaine and Calcitonin
    Evaluation of analgesia for patients undergoing laparoscopic cholecystectomy using ropivacaine and calcitonin
    بی دردی برای بیماران تحت عمل جراحی کوله سیستکتومی لاپاراسکوپیک به کمک داروی روپیوکایین و کلسیتونین
    بررسی بی دردی برای بیماران تحت عمل جراحی کوله سیستکتومی لاپاراسکوپیک به کمک داروی روپیوکایین و کلسیتونین
    Efficacy of Calcitonin adjuvant analgesia to Ropivacaine in Subcostal Transverse Abdominal Plate Block (STAP) for Laparoscopic Cholecystectomy
    Evaluation of the palliative efficacy of adding calcitonin to ropivacaine in subcostal transverse abdominal plane (STAP) block for laparoscopic cholecystectomy

  • Secondary outcomes

    #1
    Postoperative pain in rest and after cough according to VAS score
    Pain in rest
    نمرات درد در استراحت و سرفه بر اساس اسکور VAS
    درد در استراحت
    0, 2 ,4 ,6 ,12, 24 hours Postoperative
    0, 2 ,6 ,12, 24 hours Postoperative
    0، 2، 4، 6، 12، 24 ساعت پس از عمل
    0، 2، 6، 12، 24 ساعت پس از عمل

  • Intervention groups

    #1
    Intervention group: RC group (ropivacaine with calcitonin): - Bilateral STAP block with 20 mL ropivacaine solution 0.2% + 50 calcitonin units on each side
    Intervention group: RC group (ropivacaine with calcitonin): - Bilateral STAP ( Subcostal Transversus Abdominis Plane Block ) with 20 mL ropivacaine solution 0.2% + 50 calcitonin units on each side
    گروه مداخله: گروه RC (روپیواکائین با کلسیتونین): - بلوک TAP ساب کوستال دوطرفه با 20 میلی لیتر محلول روپیواکائین 0.2 درصد + 50 واحد کلسی تونین در هر سمت
    گروه مداخله: گروه RC (روپیواکائین با کلسیتونین): - بلوک TAP ( Transversus Abdominis Plane Block ) ساب کوستال دوطرفه با 20 میلی لیتر محلول روپیواکائین 0.2 درصد + 50 واحد کلسی تونین در هر سمت

  • Recruitment centers

    #1
    Name of recruitment center - English: Imam Hossein Hospital
    Name of recruitment center - Persian: بیمارستان امام حسین
    Full name of responsible person - English: Alireza Shakeri
    Full name of responsible person - Persian: علیرضا شاکری
    Street address - English: Shahid Madani st, Imam ali Hwy
    Street address - Persian: بزرگراه امام علی، خ شهید مدنی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1617763141
    Phone: +98 21 7343 0000
    Fax:
    Email: dr.alirezashakeri@gmail.com
    Web page address:
    Name of recruitment center - English: Imam Hossein Hospital
    Name of recruitment center - Persian: بیمارستان امام حسین
    Full name of responsible person - English: Alireza Shakeri
    Full name of responsible person - Persian: علیرضا شاکری
    Street address - English: Shahid Madani st, Emam Hosein Sq.
    Street address - Persian: میدان امام حسین، ابتدای خیابان شهید مدنی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1617763141
    Phone: +98 21 7343 0000
    Fax:
    Email: dr.alirezashakeri@gmail.com
    Web page address: https://modarres.sbmu.ac.ir/
    #2
    Name of recruitment center - English: Shahid Modarres Hospital
    Name of recruitment center - Persian: بیمارستان شهید مدرس
    Full name of responsible person - English: Maede Karimian
    Full name of responsible person - Persian: مایده کریمیان
    Street address - English: Yadegar Emam Highway, Saadat abad
    Street address - Persian: بزرگراه یادگار امام (ره) ـ تقاطع سعادت آباد
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1998734383
    Phone: +98 21 23515
    Fax:
    Email: m_karimian1990@yahoo.com
    Web page address:
    Name of recruitment center - English: Shahid Modarres Hospital
    Name of recruitment center - Persian: بیمارستان شهید مدرس
    Full name of responsible person - English: Maede Karimian
    Full name of responsible person - Persian: مایده کریمیان
    Street address - English: Saadat abad Blv, Saadat abad crossing with Yadegar Emam Highway
    Street address - Persian: بزرگراه یادگار امام (ره) ـ تقاطع سعادت آباد ، بلوار سعادت آباد
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1998734383
    Phone: +98 21 23515
    Fax:
    Email: m_karimian1990@yahoo.com
    Web page address: https://ehmc.sbmu.ac.ir/

  • Sponsors / Funding sources

    #1
    گرنت استادیاران جوان وزارت ، گرنت پیشتاز
    گرنت استادیاران جوان وزارت، گرنت پیشتاز

  • Person responsible for general inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Alireza Shakeri
    Full name of responsible person - Persian: علیرضا شاکری
    Position - English: َAssistant Professor
    Position - Persian: استادیار
    Latest degree: specialist
    Area of specialty/work: 24
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Imam Hossein Hospital, Shahid Madani St
    Street address - Persian: بیمارستان امام حسین، خیابان شهید مدنی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1617763141
    Phone: +98 21 7343 0000
    Mobile: +98 912 779 6712
    Fax:
    Email: dr.alirezashakeri@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Alireza Shakeri
    Full name of responsible person - Persian: علیرضا شاکری
    Position - English: َAssistant Professor
    Position - Persian: استادیار
    Latest degree: specialist
    Area of specialty/work: 24
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Imam Hossein Hospital, Shahid Madani St
    Street address - Persian: خیابان شهید مدنی، بیمارستان امام حسین
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1617763141
    Phone: +98 21 7343 0000
    Mobile: +98 912 779 6712
    Fax:
    Email: dr.alirezashakeri@gmail.com
    Web page address:

  • Person responsible for scientific inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Alireza Shakeri
    Full name of responsible person - Persian: علیرضا شاکری
    Position - English: Assistant Professor
    Position - Persian: استادیار
    Latest degree: specialist
    Area of specialty/work: 24
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Imam Hossein Hospital, Shahid Madani St
    Street address - Persian: بیمارستان امام حسین، خیابان شهید مدنی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1617763141
    Phone: +98 21 7343 0000
    Mobile: +98 912 779 6712
    Fax:
    Email: dr.alirezashakeri@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Alireza Shakeri
    Full name of responsible person - Persian: علیرضا شاکری
    Position - English: Assistant Professor
    Position - Persian: استادیار
    Latest degree: specialist
    Area of specialty/work: 24
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Imam Hossein Hospital, Shahid Madani St
    Street address - Persian: خیابان شهید مدنی، بیمارستان امام حسین
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1617763141
    Phone: +98 21 7343 0000
    Mobile: +98 912 779 6712
    Fax:
    Email: dr.alirezashakeri@gmail.com
    Web page address:

  • Person responsible for updating data


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Seyed Mohammad Seyed alshohadaei
    Full name of responsible person - Persian: سید محمد سیدالشهدایی
    Position - English: Assistant professor
    Position - Persian: استادیار
    Latest degree: specialist
    Area of specialty/work: 24
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Saadat abad Blv, Saadat abad crossing with Yadegar Emam Highway
    Street address - Persian: بزرگراه یادگار امام (ره) ـ تقاطع سعادت آباد ، بلوار سعادت آباد
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1998734383
    Phone: +98 21 23515
    Mobile: +98 912 533 0797
    Fax:
    Email: Sinsinasin@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Seyed Mohammad Seyed alshohadaei
    Full name of responsible person - Persian: سید محمد سیدالشهدایی
    Position - English: Assistant professor
    Position - Persian: استادیار
    Latest degree: specialist
    Area of specialty/work: 24
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Saadat abad Blv, Saadat abad crossing with Yadegar Emam Highway
    Street address - Persian: بزرگراه یادگار امام (ره)، تقاطع سعادت آباد، بلوار سعادت آباد
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1998734383
    Phone: +98 21 23515
    Mobile: +98 912 533 0797
    Fax:
    Email: Sinsinasin@gmail.com
    Web page address:

Protocol summary

Study aim
Comparison of time to first rescue analgesic inpatients receiving STAP block with ropivacaine and calcitonin and patients receiving ropivacaine alone.
Design
A clinical trial with 2 groups, with parallel groups, triple-blinded, randomized, phase 3 on 36 patients. For randomization, simple randomization is used using a random number table.
Settings and conduct
The STAP block is performed under ultrasound guidance and using a linear probe. After determining the layer of abdominal wall muscles (external oblique, internal oblique, and transverse abdominis), the needle is inserted into the space between the internal oblique muscle and the transverse abdominis muscle and the drug solution is injected.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Mental health, adequate understanding and awareness of the patient and providing informed consent for all laparoscopic cholecystectomy surgeries
Intervention groups
RC Group (Ropivacaine with Calcitonin): - Bilateral Subcoastal TAP Block with 20 mL Ropivacaine 0.2% Solution + 50 Calcitonin Units on Each Side Group R (Ropivacaine only): - Bilateral subcostal TAP block with 0.2% ropivacaine with a volume of 20 mL for each side (containing normal saline as a placebo instead of calcitonin) Postoperative data: Time to first rescue palliative, VAS pain scores will be measured at 0, 2, 4, 6, 12, and 24 hours, total opioid intake, and incidence of adverse events (e.g., nausea, vomiting, itching)
Main outcome variables
Time to the first rescue analgesic

General information

Reason for update
Recruitment has been completed, so the actual recruitment dates were updated. The VAS assessment time points were updated in accordance with the ethics-approved protocol, and the 4-hour time point was removed. It had been entered mistakenly in the initial registration.
Acronym
IRCT registration information
IRCT registration number: IRCT20240826062868N1
Registration date: 2025-04-08, 1404/01/19
Registration timing: prospective

Last update: 2026-09-07, 1405/06/16
Update count: 1
Registration date
2025-04-08, 1404/01/19
Registrant information
Name
Seyed Mohammad Seyed Alshohadaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 23515
Email address
sinsinasin@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-03-07, 1403/12/17
Expected recruitment end date
2025-06-07, 1404/03/17
Actual recruitment start date
2025-04-20, 1404/01/31
Actual recruitment end date
2026-05-21, 1405/02/31
Trial completion date
empty
Scientific title
Evaluation of the palliative efficacy of adding calcitonin to ropivacaine in subcostal transverse abdominal plane (STAP) block for laparoscopic cholecystectomy
Public title
Evaluation of analgesia for patients undergoing laparoscopic cholecystectomy using ropivacaine and calcitonin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 - 65 Elective laparoscopic cholecystectomy surgery ASA (American Society of Anesthesiologists) I-II patients
Exclusion criteria:
Contraindications for regional block Study drugs allergy Pregnancy Chronic pain drug users Cognitive disorders Substance and palliative drug addiction
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 36
Actual sample size reached: 36
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, a simple randomization method was used using a table of random numbers and through the Random generator program. In this randomization, patients who meet the criteria for entering the study are assigned a number before anesthesia, which will represent one of the two study groups.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Syringes containing study drugs are prepared identically by a person who is not involved in the care of the patients. Anesthesiologists, patients, outcome evaluators and data analyzer will be unaware of group allocation to ensure unbiased results.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Yaman st., Shahid Chamran Hwy.
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2025-01-11, 1403/10/22
Ethics committee reference number
IR.SBMU.RETECH.REC.1403.687

Health conditions studied

1

Description of health condition studied
Analgesia after laparoscopic cholecystectomy surgery
ICD-10 code
K81.0
ICD-10 code description
Acute cholecystitis

Primary outcomes

1

Description
First time to need rescue analgesic
Timepoint
24 hours after surgery
Method of measurement
Hour

Secondary outcomes

1

Description
Pain in rest
Timepoint
0, 2 ,6 ,12, 24 hours Postoperative
Method of measurement
Visual analog scale

2

Description
Perioperative opioid consumption
Timepoint
Perioperative and to 24 after surgery
Method of measurement
Patient file information

3

Description
Side effects incidence
Timepoint
Yes or no
Method of measurement
Patient file record

Intervention groups

1

Description
Intervention group: RC group (ropivacaine with calcitonin): - Bilateral STAP ( Subcostal Transversus Abdominis Plane Block ) with 20 mL ropivacaine solution 0.2% + 50 calcitonin units on each side
Category
Treatment - Drugs

2

Description
Control group: Group R (ropivacaine only): - Bilateral STAP block with 0.2% ropivacaine with a volume of 20 mL for each side (containing normal saline as a placebo instead of calcitonin)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Alireza Shakeri
Street address
Shahid Madani st, Emam Hosein Sq.
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
dr.alirezashakeri@gmail.com
Web page address
https://modarres.sbmu.ac.ir/

2

Recruitment center
Name of recruitment center
Shahid Modarres Hospital
Full name of responsible person
Maede Karimian
Street address
Saadat abad Blv, Saadat abad crossing with Yadegar Emam Highway
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 23515
Email
m_karimian1990@yahoo.com
Web page address
https://ehmc.sbmu.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Vice President for Research, Shahid Beheshti University of Medical Sciences, Next to Taleghani Hospital, Yemen Street, Shahid Chamran Highway, Tehrani, Iran
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2243 9331
Email
zarghi@sbmu.ac.ir
Grant name
Grant to Young Assistant Professors of Ministry, Pioneer Grant
Grant code / Reference number
د/4040/700
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Alireza Shakeri
Position
َAssistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Hossein Hospital, Shahid Madani St
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
dr.alirezashakeri@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Alireza Shakeri
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Hossein Hospital, Shahid Madani St
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
dr.alirezashakeri@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Mohammad Seyed alshohadaei
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Saadat abad Blv, Saadat abad crossing with Yadegar Emam Highway
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 23515
Fax
Email
Sinsinasin@gmail.com

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 more information
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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