Subcostal Transversus Abdominis Plane BlockNCT05826652
Subcostal TAP Block With Single or Multiple Injection
A study testing Single injection subcostal transversus abdominis plane block, Multiple injection subcostal transversus abdominis plane block and Without Block in people with Subcostal Transversus Abdominis Plane Block, run by Istanbul Medeniyet University at 2 sites in Turkey (Türkiye).
Trial summary
It was aimed to control pain with right-sided subcostal transversus abdominis plane block application, which is performed by applying different techniques in laparoscopic cholecystectomy operations in this study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Subcostal Transversus Abdominis Plane Block
- What is being tested?
- Single injection subcostal transversus abdominis plane block, Multiple injection subcostal transversus abdominis plane block and Without Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Dec 2022to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years old
- ASA I-III
- Patients scheduled for laparoscopic cholecystectomy operations
Who cannot join
- Those who have previously had neurological and psychiatric disease symptoms and use drugs (TIA, syncope, dementia, depression, bipolar disorder, etc.)
- Patients with known allergy to local anesthetics
- Chronic opioid or corticosteroid users
- Those with coagulopathy
- Those with local or systemic infections
- BMI>40 kg/m2
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Istanbul Medeniyet University
Istanbul, 34730
Medeniyet University
Istanbul, 34887
About this study
Official title: The Effect of Unilateral Subcostal Transversus Abdominis Plane Block Applied as Single or Multiple Injections on Pain in Laparoscopic Cholecystectomy Operations
It was aimed to control pain with right-sided subcostal transversus abdominis plane block application, which is performed by applying different techniques in laparoscopic cholecystectomy operations in this study. Considering that applying technique is important in this block, the results of this study can guide practitioners in this field.
Read the detailed description
A total of 90 patients, aged 18 to 65 years, with American Society of Anesthesiologists (ASA) physical status I-III, scheduled for laparoscopic cholecystectomy, will be enrolled in this study. Exclusion criteria encompasse a history of allergy to local anesthetics, chronic analgesic use, psychiatric disorders, renal or hepatic dysfunction, coagulopathy, a body mass index (BMI) > 40 kg/m², and pregnancy. Patients in Group S receive a subcostal TAP block with a single injection, patients in Group T receive a subcostal TAP block with multiple injections, and patients in Group C will not receive any form of block.
Standard monitoring protocols will be implemented upon arrival in the operating theatre and heart rate (HR), mean arterial pressure (MAP), and peripheral oxygen saturation (SpO2) will be recorded during operation. Anesthesia will be induced using propofol (2 mg/kg) and fentanyl (1 μg/kg) and muscle relaxation is achieved with rocuronium (0.5 mg/kg). and maintained using sevoflurane in a 50:50 air/oxygen mixture at a flow rate of 1 L/min. Intraoperative analgesia will be provided through a remifentanil infusion at a rate of 0-0.2 μg/kg/min.
Prior to the initiation of surgery, the subcostal TAP block will be administered in Groups S and T under sterile conditions using ultrasound guidance. A single injection of 20 mL of 0.25% bupivacaine will be administered above the transversus abdominis muscle adjacent to the linea semilunaris to the left sides of the patients in Group S. The patients in Group T will be given three distinct injections to their left sides: 10 mL of 0.25% bupivacaine above the transversus abdominis muscle adjacent to the linea semilunaris, 5 mL of 0.25% bupivacaine between the transversus abdominis and internal oblique muscles in the subcostal region above the midclavicular line and 5 mL of 0.25% bupivacaine between the transversus abdominis and internal oblique muscles in the subcostal region above the anterior axillary line.
Laparoscopic cholecystectomy will be performed using four trocar placements on the right side of the abdomen. Postoperative analgesia was managed with a patient-controlled analgesia (PCA) device containing tramadol.
Postoperative remifentanil concumption will be estimated at the end of the operation. Assessments will be conducted at 30th minute, 1st, 3rd, 6st and 24th hours postoperatively, with parameters including pain, nausea, and total PCA consumption. Pain intensity will be measured using the Visual Analogue Scale (VAS; 0 = no pain, 10 = worst imaginable pain). Postoperative nausea and vomiting (PONV) will be evaluated using a verbal descriptive scale (VDS) (0: No PONV, 1: Mild PONV, 2: Moderate PONV, 3: Severe PONV) [10]. Patient satisfaction will beevaluated at discharge using a five-point Likert scale (1 = strongly unsatisfied, 5 = strongly satisfied). Complications, including infection, bleeding, and subcutaneous emphysema will be documented.
- Being tested
- Single injection subcostal transversus abdominis plane block, Multiple injection subcostal transversus abdominis plane block, Without Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single injection subcostal transversus abdominis plane blockOther
Single injection subcostal transversus abdominis plane block will be applied with %2,5 Marcaine 20 ml between tranvers and rectus abdominis muscle immediately next to the linea semilunaris.
Multiple injection subcostal transversus abdominis plane blockOther
Multiple injection subcostal transversus abdominis plane block will be applied with %2,5 Marcaine 5 ml between transverse and rectus abdominis muscle, 5 ml on the transverse muscle near the semilunaris and two more 5 ml volume lateral to this point near the subcostal margin.
Without BlockProcedure or surgery
The patients in this group will not receive block
| Study group | Role | What they receive |
|---|---|---|
| Multiple injection subcostal transversus abdominis plane block | Active comparator | . The patients in multiple injection will be given three distinct injections: 10 mL of 0.25% bupivacaine above the transversus abdominis muscle adjacent to the linea semilunaris, 5 mL of 0.25% bupivacaine between the transversus abdominis and internal oblique muscles in the subcostal region above the midclavicular line and 5 mL of 0.25% bupivacaine between the transversus abdominis and internal oblique muscles in the subcostal region above the anterior axillary line. Receives: Other: Multiple injection subcostal transversus abdominis plane block |
| Single injection subcostal transversus abdominis plane block | Active comparator | A single injection of 20 mL of 0.25% bupivacaine will be administered above the transversus abdominis muscle adjacent to the linea semilunaris to the patients in Group S. Receives: Other: Single injection subcostal transversus abdominis plane block |
| Without Block | Active comparator | The patients in this group will not receive any block Receives: Procedure: Without Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tramadol consumption
Postoperative opiod consumption
Measured: 10 minutes, 30 minutes, 1, 3, 6, 24 hours postoperatively
Remifentanil consumption
Intraoperative opiod consumption
Measured: up to 2 hours
Secondary outcomes (11)
Visual analog scale
Visual analog scale: 0 = no pain; 10 = the most severe pain you can imagine
Measured: 30. minute
Visual analog scale
Visual ananlog scale: 0 = no pain; 10 = the most severe pain you can imagine
Measured: 1. hour
Visual analog scale
Visual analog scale: 0 = no pain; 10 = the most severe pain you can imagine
Measured: 3. hour
Visual analog scale
Visual analog scale: 0 = no pain; 10 = the most severe pain you can imagine
Measured: 6. hour
Visual analog scale
Visual analog scale: 0 = no pain; 10 = the most severe pain you can imagine
Measured: 24. hour
Postoperative nausea and vomiting
Verbal descriptive scale. 0: No PONV, 1: Mild PONV, 2: Moderate PONV, 3: Severe PONV
Measured: 30. minute
Postoperative nausea and vomiting
Verbal descriptive scale:0: No PONV, 1: Mild PONV, 2: Moderate PONV, 3: Severe PONV
Measured: 1. hour
Postoperative nausea and vomiting
Verbal descriptive scale:0: No PONV, 1: Mild PONV, 2: Moderate PONV, 3: Severe PONV
Measured: 3. hour
Postoperative nausea and vomiting
Verbal descriptive scale:0: No PONV, 1: Mild PONV, 2: Moderate PONV, 3: Severe PONV
Measured: 6. hour
Postoperative nausea and vomiting
Verbal descriptive scale:0: No PONV, 1: Mild PONV, 2: Moderate PONV, 3: Severe PONV
Measured: 24. hour
Patient satisfaction
Five-point Likert scale: 1 = strongly unsatisfied, 5 = strongly satisfied
Measured: 24. hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start1 Dec 2022
- Primary completion31 May 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subcostal Transversus Abdominis Plane BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mesure gul nihan ozden, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05826652
- Sponsor's protocol ID
- IstanbulMU Subcostal TAP Block
- Status last verified
- Feb 2025
- First submitted
- 26 Mar 2023
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Unilateral Subcostal Transversus Abdominis Plane Block Applied as Single or Multiple Injections on Pain in Laparoscopic Cholecystectomy Operations
- ClinicalTrials.gov ID
- NCT05826652
- Acronym / sponsor ID
- IstanbulMU Subcostal TAP Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 24 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It was aimed to control pain with right-sided subcostal transversus abdominis plane block application, which is performed by applying different techniques in laparoscopic cholecystectomy operations in this study. Considering that applying technique is important in this block, the results of this study can guide practitioners in this field.
Detailed description
A total of 90 patients, aged 18 to 65 years, with American Society of Anesthesiologists (ASA) physical status I-III, scheduled for laparoscopic cholecystectomy, will be enrolled in this study. Exclusion criteria encompasse a history of allergy to local anesthetics, chronic analgesic use, psychiatric disorders, renal or hepatic dysfunction, coagulopathy, a body mass index (BMI) > 40 kg/m², and pregnancy. Patients in Group S receive a subcostal TAP block with a single injection, patients in Group T receive a subcostal TAP block with multiple injections, and patients in Group C will not receive any form of block.
Standard monitoring protocols will be implemented upon arrival in the operating theatre and heart rate (HR), mean arterial pressure (MAP), and peripheral oxygen saturation (SpO2) will be recorded during operation. Anesthesia will be induced using propofol (2 mg/kg) and fentanyl (1 μg/kg) and muscle relaxation is achieved with rocuronium (0.5 mg/kg). and maintained using sevoflurane in a 50:50 air/oxygen mixture at a flow rate of 1 L/min. Intraoperative analgesia will be provided through a remifentanil infusion at a rate of 0-0.2 μg/kg/min.
Prior to the initiation of surgery, the subcostal TAP block will be administered in Groups S and T under sterile conditions using ultrasound guidance. A single injection of 20 mL of 0.25% bupivacaine will be administered above the transversus abdominis muscle adjacent to the linea semilunaris to the left sides of the patients in Group S. The patients in Group T will be given three distinct injections to their left sides: 10 mL of 0.25% bupivacaine above the transversus abdominis muscle adjacent to the linea semilunaris, 5 mL of 0.25% bupivacaine between the transversus abdominis and internal oblique muscles in the subcostal region above the midclavicular line and 5 mL of 0.25% bupivacaine between the transversus abdominis and internal oblique muscles in the subcostal region above the anterior axillary line.
Laparoscopic cholecystectomy will be performed using four trocar placements on the right side of the abdomen. Postoperative analgesia was managed with a patient-controlled analgesia (PCA) device containing tramadol.
Postoperative remifentanil concumption will be estimated at the end of the operation. Assessments will be conducted at 30th minute, 1st, 3rd, 6st and 24th hours postoperatively, with parameters including pain, nausea, and total PCA consumption. Pain intensity will be measured using the Visual Analogue Scale (VAS; 0 = no pain, 10 = worst imaginable pain). Postoperative nausea and vomiting (PONV) will be evaluated using a verbal descriptive scale (VDS) (0: No PONV, 1: Mild PONV, 2: Moderate PONV, 3: Severe PONV) [10]. Patient satisfaction will beevaluated at discharge using a five-point Likert scale (1 = strongly unsatisfied, 5 = strongly satisfied). Complications, including infection, bleeding, and subcutaneous emphysema will be documented.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Multiple injection subcostal transversus abdominis plane block | Active comparator | Other: Multiple injection subcostal transversus abdominis plane block. The patients in multiple injection will be given three distinct injections: 10 mL of 0.25% bupivacaine above the transversus abdominis muscle adjacent to the linea semilunaris, 5 mL of 0.25% bupivacaine between the transversus abdominis and internal oblique muscles in the subcostal region above the midclavicular line and 5 mL of 0.25% bupivacaine between the transversus abdominis and internal oblique muscles in the subcostal region above the anterior axillary line. |
| Single injection subcostal transversus abdominis plane block | Active comparator | Other: Single injection subcostal transversus abdominis plane blockA single injection of 20 mL of 0.25% bupivacaine will be administered above the transversus abdominis muscle adjacent to the linea semilunaris to the patients in Group S. |
| Without Block | Active comparator | Procedure: Without BlockThe patients in this group will not receive any block |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-65 years old
- ASA I-III
- Patients scheduled for laparoscopic cholecystectomy operations
Key exclusion criteria (6 listed)
- Those who have previously had neurological and psychiatric disease symptoms and use drugs (TIA, syncope, dementia, depression, bipolar disorder, etc.)
- Patients with known allergy to local anesthetics
- Chronic opioid or corticosteroid users
- Those with coagulopathy
- Those with local or systemic infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single injection subcostal transversus abdominis plane blockSingle injection subcostal transversus abdominis plane block will be applied with %2,5 Marcaine 20 ml between tranvers and rectus abdominis muscle immediately next to the linea semilunaris. | Other | Single injection subcostal transversus abdominis plane block |
| Multiple injection subcostal transversus abdominis plane blockMultiple injection subcostal transversus abdominis plane block will be applied with %2,5 Marcaine 5 ml between transverse and rectus abdominis muscle, 5 ml on the transverse muscle near the semilunaris and two more 5 ml volume lateral to this point near the subcostal margin. | Other | Multiple injection subcostal transversus abdominis plane block |
| Without BlockThe patients in this group will not receive block | Procedure or surgery | Without Block |
Primary outcome
Tramadol consumption
Time frame: 10 minutes, 30 minutes, 1, 3, 6, 24 hours postoperatively
Postoperative opiod consumption
Remifentanil consumption
Time frame: up to 2 hours
Intraoperative opiod consumption
11 secondary outcomes
Visual analog scale
Time frame: 30. minute
Visual analog scale
Time frame: 1. hour
Visual analog scale
Time frame: 3. hour
Visual analog scale
Time frame: 6. hour
Visual analog scale
Time frame: 24. hour
Postoperative nausea and vomiting
Time frame: 30. minute
Postoperative nausea and vomiting
Time frame: 1. hour
Postoperative nausea and vomiting
Time frame: 3. hour
Postoperative nausea and vomiting
Time frame: 6. hour
Postoperative nausea and vomiting
Time frame: 24. hour
Patient satisfaction
Time frame: 24. hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single injection subcostal transversus abdominis plane block, Multiple injection subcostal transversus abdominis plane block and Without Block in people with Subcostal Transversus Abdominis Plane Block, run by Istanbul Medeniyet University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tramadol consumption (time frame: 10 minutes, 30 minutes, 1, 3, 6, 24 hours postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.