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Completed

NCT Number: NCT05398406

Subcostal Transversus Abdominus , Erector Spinae and Paravertebral Blocks Effects on Laparoscopic Cholecystectomy Cases

Sixty patients with ASA (American Society of Anesthesiologist) I-II physical status between the ages of 20-60 were randomized into three groups: TAP block group (Group T), ESP block group (Group E) and PVB group (Group P). Bilateral 20cc (total 40cc for each patient) 0.25% bupivacaine was applied by ultrasound (US) guidance. Intraoperative vital signs (heart rate, blood pressure, and saturation), Train-of-four (TOF) values, additional dose of opioid and muscle relaxant needs, complications were recorded. Postoperative side effects (nausea, vomiting, itching, tremor), the need for additional postoperative analgesia, Visual Analog Scale (VAS) scores were noted.

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Key information

Conditions

Comparison Evaluation

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Van Yuzuncu Yil University

Van, Tuşba, 65000, Turkey (Türkiye)

About this study

Cases; under the age of 20 - over 60, emerge and bleeding, outside the ASAI-II functional status, undergo surgery other than laparoscopic cholecystectomy, refused to participate in the study, allergic to local anesthetic agents, with a body mass index (BMI) >30, have contraindications for regional anesthesia (sepsis, local infection, coagulopathy, heart disease, hypovolemia, cases that do not want regional anesthesia), pregnant were not included in the study.Twenty patients in each group and a total of 60 patients were included the study by power analysis. According to the randomized, single-blind, closed-envelope method, patients were randomly divided into three groups.

Group T (Subcostal TAP Block): 40 cc (20cc+20cc) 0.25 % Bupivacaine for bilateral application Group E (ESP Block): 40 cc (20cc+20cc) 0.25% Bupivacaine for bilateral application Group P (PVB): 40 cc (20cc+20cc) 0.25% Bupivacaine for bilateral application were prepared.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 20-60 years,
  • ASA I-II ,
  • scheduled for elective laparoscopic cholecystectomy
  • under general anesthesia,
  • agreed to participate in the study,

Exclusion criteria

  • under the age of 20 - over 60,
  • emerge and bleeding,
  • outside the ASAI-II functional status,
  • undergo surgery other than laparoscopic cholecystectomy,
  • refused to participate in the study, allergic to local anesthetic agents,
  • body mass index (BMI) >30,
  • have contraindications for regional anesthesia (sepsis, local infection, coagulopathy, heart disease, hypovolemia, cases that do not want regional anesthesia),
  • pregnant

Treatment and study plan

TAP Block group

Other

TAP Block: the US probe was placed on the imaginary line connecting the anterior superior iliac spine and the umbilicus. The ilioinguinal and iliohypogastric nerves in the fascia of the internal obliq and transverse abdominis muscles were visualized by US. A total of 40 ml of local anesthetic was infiltrated ESP Blok : a 100 mm 21G peripheral nerve block needle was inserted between the erector spinae muscle and the transverse process structures in an in-plane section guided by US from the T7-8 level. 40 ml of the prepared solutions were injected PVB: In the lateral decubitus position, the cranial to caudal transverse processes and the superior costotransverse ligament and the pleura were visualized from the T7-8 level in the in-plane section under US guidance. A 100 mm 21G peripheral nerve block needle was advanced until it passed through the superior costotransverse ligament. A total of 40 ml of injections were made

Other names: Paravertebral block group, Erector spinae block group

Paravertebral block group

Other

In the lateral decubitus position, the cranial to caudal transverse processes and the superior costotransverse ligament and the pleura were visualized from the T7-8 level in the in-plane section under US guidance. A 100 mm 21G peripheral nerve block needle (SonoPlex Stim Cannula, PAJUNK®, USA) was advanced until it passed through the superior costotransverse ligament. A total of 40 ml of injections were made bilaterally in the form of 20+20 ml.

Other names: PVB group

Erector spinae block group

Other

In the lateral decubitus position, a 100 mm 21G peripheral nerve block needle (SonoPlex Stim Cannula, PAJUNK®,USA) was inserted between the erector spinae muscle and the transverse process structures in an in-plane section guided by US from the T7-8 level. A total of 40 ml of the prepared solutions were injected bilaterally as 20+20 ml.

Other names: ESP block group

Primary outcomes

  1. Postoperative pain intensity measured by 10-cm Visual Analogue Scale (VAS)

    Time frame: 6 hours postoperatively

    Pain intensity assessed using a 10-cm Visual Analogue Scale (VAS), where 0 indicates no pain and 10 indicates worst imaginable pain.

Secondary outcomes

  1. Postoperative rescue analgesic requirement

    Time frame: Within the first 6 hours postoperatively

    Requirement for rescue analgesia (intravenous dexketoprofen 50 mg) administered for VAS ≥5.

  2. Intraoperative opioid consumption

    Time frame: During surgery

    Total intraoperative supplemental fentanyl requirement administered in response to hemodynamic changes.

  3. Intraoperative neuromuscular blocker requirement

    Time frame: During surgery

    Supplemental intraoperative rocuronium requirement based on train-of-four (TOF) monitoring.

  4. Incidence of postoperative adverse events

    Time frame: Within the first 6 hours postoperatively

    Incidence of postoperative nausea, vomiting, shivering, pruritus, and oxygen desaturation recorded during the early postoperative period.

  5. Time to first mobilization

    Time frame: Within the first 6 hours postoperatively

    Time from arrival in the recovery unit to first independent mobilization (standing or walking without assistance).

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Registry information

Official study title

Subcostal Transversus Abdominus Plane Block, Erector Spinae Plane Block and Paravertebral Blocks Effects

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jun 1, 2022
Registry last updated
Mar 5, 2026

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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