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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05398406
Enrollment
60
Registered
2022-06-01
Start date
2020-01-01
Completion date
2021-01-01
Last updated
2026-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Comparison, Evaluation

Keywords

plane blocks, ultrasonography, bupivacaine

Brief summary

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.

Detailed description

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.

Interventions

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

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.

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.

Sponsors

Yuzuncu Yil University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

This was a single-blind study. Participants and the investigator assessing postoperative outcomes were blinded to group allocation. The anesthesiologist performing the regional blocks was not involved in postoperative data collection.

Intervention model description

randomized, single-blind, closed-envelope method

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative pain intensity measured by 10-cm Visual Analogue Scale (VAS)6 hours postoperativelyPain intensity assessed using a 10-cm Visual Analogue Scale (VAS), where 0 indicates no pain and 10 indicates worst imaginable pain.

Secondary

MeasureTime frameDescription
Postoperative rescue analgesic requirementWithin the first 6 hours postoperativelyRequirement for rescue analgesia (intravenous dexketoprofen 50 mg) administered for VAS ≥5.
Intraoperative opioid consumptionDuring surgeryTotal intraoperative supplemental fentanyl requirement administered in response to hemodynamic changes.
Intraoperative neuromuscular blocker requirementDuring surgerySupplemental intraoperative rocuronium requirement based on train-of-four (TOF) monitoring.
Incidence of postoperative adverse eventsWithin the first 6 hours postoperativelyIncidence of postoperative nausea, vomiting, shivering, pruritus, and oxygen desaturation recorded during the early postoperative period.
Time to first mobilizationWithin the first 6 hours postoperativelyTime from arrival in the recovery unit to first independent mobilization (standing or walking without assistance).

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORArzu E Tekeli, MD

Yuzuncu Yil University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026