Comparison of Erector Spina Plan Block and Trnsversus Abdominis Plan Block in Laparoscopic Nephrectomy: Prospective Randomized Clinical Trial

December 1, 2023 updated by: Zehra Ipek ARSLAN, Kocaeli University

Comparison of Erector Spina and Transversus Abdominus Plan Blocks

Nephrectomy pain was higher. erector spina plan block and transversus abdominis plan block had shown to be effective in abdominal surgeries. This study aimed to compare these two bloc analgesic efficacy in laparoscopic nephrectomy patients. The primary aim is postoperative morphine consumption.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients ASA 18-65 who will undergo laparoscopic nephrectomy are included in this prospective randomized clinical trial. Patients will be divided into two groups; erector spina and transversus abdominis plane block. Anesthesia will. induced with propofol, fentanyl, and rocuronium will be administered for muscle relaxation. Bispectral index monitoring will be used for monitorisation of the depth of anesthesia. Remifentanil was used during the whole procedure. the amount of consumption will be recorded. Patient-controlled device will be used with morphine. The postoperative morphine consumption will also be recorded.

Study Type

Interventional

Enrollment (Estimated)

50

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 Contact Backup

Study Locations

  • Turkey
      • Kocaeli, Turkey, 41900
        • Recruiting
        • Kocaeli University
        • Contact:
        • Principal Investigator:
          • Zehra I ARSLAN, Associate Professor

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:

  • 18-65 age
  • patients undergoing laparoscopic nephrectomy
  • ASA 1-3

Exclusion Criteria:

  • <18- >65 < age
  • patients undergoing open nephrectomy
  • ASA 4-5

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Erector spina plan block
Erector spina plan block will be administered to the patients in this group.
Procedure: laparoscopic nephrectomy
laparoscopic nephrectomy
Active Comparator: Transversus abdominis plan block
Transversus abdominis plan block will be administered to the patients in this group.
Procedure: laparoscopic nephrectomy
laparoscopic nephrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative morphine consumption
Time Frame: 24 hour postoperatively
morphine patient controlled analgesia was applied to the patients
24 hour postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative analgesia numeric rating scales
Time Frame: postoperative 24 hours
patients will give numbers to their pain first hour, 6th hour and 24 th hour after surgery
postoperative 24 hours
Peroperative remifentanil consumptions
Time Frame: peroperatively
continious remifentanil infusion was applied
peroperatively

Collaborators and Investigators

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

Sponsor

Kocaeli University

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 (Actual)

August 15, 2023

Primary Completion (Estimated)

June 15, 2025

Study Completion (Estimated)

June 15, 2025

Study Registration Dates

First Submitted

June 12, 2023

First Submitted That Met QC Criteria

June 12, 2023

First Posted (Actual)

June 22, 2023

Study Record Updates

Last Update Posted (Estimated)

December 8, 2023

Last Update Submitted That Met QC Criteria

December 1, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • LAPNEF2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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