AzTrials
AzTrials

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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
What is being tested?
Single injection subcostal transversus abdominis plane block, Multiple injection subcostal transversus abdominis plane block and Without Block
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

Other trials in Turkey (Türkiye)

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 groups in NCT05826652
Study groupRoleWhat they receive
Multiple injection subcostal transversus abdominis plane blockActive 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 blockActive comparatorA 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 BlockActive comparatorThe 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.

  1. Tramadol consumption

    Postoperative opiod consumption

    Measured: 10 minutes, 30 minutes, 1, 3, 6, 24 hours postoperatively

  2. Remifentanil consumption

    Intraoperative opiod consumption

    Measured: up to 2 hours

Secondary outcomes (11)
  1. Visual analog scale

    Visual analog scale: 0 = no pain; 10 = the most severe pain you can imagine

    Measured: 30. minute

  2. Visual analog scale

    Visual ananlog scale: 0 = no pain; 10 = the most severe pain you can imagine

    Measured: 1. hour

  3. Visual analog scale

    Visual analog scale: 0 = no pain; 10 = the most severe pain you can imagine

    Measured: 3. hour

  4. Visual analog scale

    Visual analog scale: 0 = no pain; 10 = the most severe pain you can imagine

    Measured: 6. hour

  5. Visual analog scale

    Visual analog scale: 0 = no pain; 10 = the most severe pain you can imagine

    Measured: 24. hour

  6. Postoperative nausea and vomiting

    Verbal descriptive scale. 0: No PONV, 1: Mild PONV, 2: Moderate PONV, 3: Severe PONV

    Measured: 30. minute

  7. Postoperative nausea and vomiting

    Verbal descriptive scale:0: No PONV, 1: Mild PONV, 2: Moderate PONV, 3: Severe PONV

    Measured: 1. hour

  8. Postoperative nausea and vomiting

    Verbal descriptive scale:0: No PONV, 1: Mild PONV, 2: Moderate PONV, 3: Severe PONV

    Measured: 3. hour

  9. Postoperative nausea and vomiting

    Verbal descriptive scale:0: No PONV, 1: Mild PONV, 2: Moderate PONV, 3: Severe PONV

    Measured: 6. hour

  10. Postoperative nausea and vomiting

    Verbal descriptive scale:0: No PONV, 1: Mild PONV, 2: Moderate PONV, 3: Severe PONV

    Measured: 24. hour

  11. 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.

  1. First posted24 Apr 2023
  2. Study start1 Dec 2022
  3. Primary completion31 May 2023
  4. Study completion1 Jun 2023

Resources

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)
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

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.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in