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Completed

NCT Number: NCT05826652

Subcostal TAP Block With Single or Multiple Injection

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medeniyet University, Istanbul, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-65 years old
  • ASA I-III
  • Patients scheduled for laparoscopic cholecystectomy operations

Exclusion criteria

  • 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

Treatment and study plan

Single injection subcostal transversus abdominis plane block

Other

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 block

Other

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 Block

Procedure

The patients in this group will not receive block

Primary outcomes

  1. Tramadol consumption

    Time frame: 10 minutes, 30 minutes, 1, 3, 6, 24 hours postoperatively

    Postoperative opiod consumption

  2. Remifentanil consumption

    Time frame: up to 2 hours

    Intraoperative opiod consumption

Secondary outcomes

  1. Visual analog scale

    Time frame: 30. minute

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

  2. Visual analog scale

    Time frame: 1. hour

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

  3. Visual analog scale

    Time frame: 3. hour

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

  4. Visual analog scale

    Time frame: 6. hour

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

  5. Visual analog scale

    Time frame: 24. hour

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

  6. Postoperative nausea and vomiting

    Time frame: 30. minute

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

  7. Postoperative nausea and vomiting

    Time frame: 1. hour

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

  8. Postoperative nausea and vomiting

    Time frame: 3. hour

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

  9. Postoperative nausea and vomiting

    Time frame: 6. hour

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

  10. Postoperative nausea and vomiting

    Time frame: 24. hour

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

  11. Patient satisfaction

    Time frame: 24. hour

    Five-point Likert scale: 1 = strongly unsatisfied, 5 = strongly satisfied

Sponsors and collaborators

Lead sponsor

Istanbul Medeniyet University

Other

Registry information

Official study title

The Effect of Unilateral Subcostal Transversus Abdominis Plane Block Applied as Single or Multiple Injections on Pain in Laparoscopic Cholecystectomy Operations

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 24, 2023
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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