Protocol summary
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Study aim
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Comparison of time to first rescue analgesic inpatients receiving STAP block with ropivacaine and calcitonin and patients receiving ropivacaine alone.
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Mental health, adequate understanding and awareness of the patient and providing informed consent for all laparoscopic cholecystectomy surgeries
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Intervention groups
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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)
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Main outcome variables
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Time to the first rescue analgesic
General information
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Reason for update
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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.
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Acronym
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IRCT registration information
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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
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Registration date
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2025-04-08, 1404/01/19
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2025-03-07, 1403/12/17
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Expected recruitment end date
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2025-06-07, 1404/03/17
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Actual recruitment start date
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2025-04-20, 1404/01/31
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Actual recruitment end date
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2026-05-21, 1405/02/31
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Trial completion date
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empty
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Scientific title
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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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Public title
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Evaluation of analgesia for patients undergoing laparoscopic cholecystectomy using ropivacaine and calcitonin
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
36
Actual sample size reached:
36
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2025-01-11, 1403/10/22
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Ethics committee reference number
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IR.SBMU.RETECH.REC.1403.687
Health conditions studied
1
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Description of health condition studied
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Analgesia after laparoscopic cholecystectomy surgery
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ICD-10 code
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K81.0
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ICD-10 code description
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Acute cholecystitis
Primary outcomes
1
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Description
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First time to need rescue analgesic
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Timepoint
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24 hours after surgery
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Method of measurement
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Hour
Secondary outcomes
1
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Description
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Pain in rest
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Timepoint
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0, 2 ,6 ,12, 24 hours Postoperative
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Method of measurement
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Visual analog scale
2
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Description
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Perioperative opioid consumption
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Timepoint
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Perioperative and to 24 after surgery
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Method of measurement
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Patient file information
3
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Description
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Side effects incidence
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Timepoint
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Yes or no
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Method of measurement
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Patient file record
Intervention groups
1
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Description
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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
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Category
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Treatment - Drugs
2
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Description
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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)
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant to Young Assistant Professors of Ministry, Pioneer Grant
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Grant code / Reference number
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د/4040/700
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Beheshti University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no more information
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available