Comparison of ESP Block and STAP Plane Block

December 4, 2024 updated by: Sevim Cesur, Kocaeli University

Comparison of ESP Block and STAP Plane Block in Laparoscopic Cholecystectomy Surgery

In order to effectively manage postoperative analgesia in patients planned to undergo elective laparoscopic cholecystectomy, patients will be divided into 2 (two) groups and informed consent forms will be obtained after the necessary information is provided so that both groups can be included in the study. In the group planned to undergo erector spinae plane block, erector spinae plane block will be performed after monitoring and sedation in the operating room block unit before being taken to the surgical table preoperatively and postoperative PCA analgesia will be applied. In patients who will undergo subcostal transversus abdominis plane block, subcostal tap block will be performed after monitoring and sedation in the operating room block unit before being taken to the surgical table preoperatively and postoperative PCA analgesia will be applied. The patients' perioperative pain will be monitored with NOL (nociception level) monitor. Remifentanil dose will be adjusted to keep the NOL level between 10 and 25. After the patients are followed up for 24 hours postoperatively, their additional analgesia needs and amounts during this process will be compared. In this way, it is aimed to show that the analgesic method can be used effectively in the follow-up of pain management by comparing the Erector Spina Plane block and the Subcostal Transversus Abdominis Plane block as an effective analgesic application in laparoscopic cholecystectomy operations.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Kocaeli, Turkey
        • Kocaeli University
        • Contact:
          • Sevim CESUR, MD
          • Phone Number: +902623038248

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients who will undergo laparoscopic cholecystectomy:
  • 18-75 years old
  • ASA I-II-III patients

Exclusion Criteria:

  • Use of anticoagulant drugs
  • Known allergy to drugs to be used
  • Infection in the area where the block will be performed
  • Patient's reluctance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: GROUP USING subcostal transversus abdominis plane block
Before being taken to the surgical table preoperatively, monitoring and sedation will be performed in the operating room block unit, then subcostal tap block will be performed and postoperative PCA will be applied.Patients' perioperative pain will be monitored with a NOL (nociception level) monitor. The remifentanil dose will be adjusted to keep the NOL level between 10 and 25. After the patients are followed up for 24 hours postoperatively, their additional analgesia needs and amounts during this period will be compared.
Procedure: subcostal transversus abdominis plane block
subcostal transversus abdominis plane block will be performed using 20 mL of 0.25 bupivacaine
Active Comparator: GROUP USING erector spinae plane block
Before being taken to the surgical table preoperatively, monitoring and sedation will be performed in the operating room block unit, then erector spinae plane block will be performed and postoperative PCA will be applied.Patients' perioperative pain will be monitored with a NOL (nociception level) monitor. The remifentanil dose will be adjusted to keep the NOL level between 10 and 25. After the patients are followed up for 24 hours postoperatively, their additional analgesia needs and amounts during this period will be compared.
Procedure: erector spinae plane block
erector spinae plane block will be performed using 20 mL of 0.25 bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NRS Scores
Time Frame: 1 hours after surgery(T1), 3 hours after surgery (T2), 6 hours after surgery (T3), 12 hours after surgery (T4) and 24 hours after surgery(T5)
NRS scores of the patients after the surgery (0=no pain, 10=worst pain imaginable)
1 hours after surgery(T1), 3 hours after surgery (T2), 6 hours after surgery (T3), 12 hours after surgery (T4) and 24 hours after surgery(T5)
Morphine consumption
Time Frame: 1 hours after surgery(T1), 3 hours after surgery (T2), 6 hours after surgery (T3), 12 hours after surgery (T4) and 24 hours after surgery(T5)
Amount of morphine consumption (mg)
1 hours after surgery(T1), 3 hours after surgery (T2), 6 hours after surgery (T3), 12 hours after surgery (T4) and 24 hours after surgery(T5)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kocaeli University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 15, 2024

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

October 14, 2024

First Submitted That Met QC Criteria

October 28, 2024

First Posted (Actual)

October 29, 2024

Study Record Updates

Last Update Posted (Estimated)

December 5, 2024

Last Update Submitted That Met QC Criteria

December 4, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KAEK/13.bI.04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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