Comparison of Postoperative Analgesic Efficacy of the Erector Spina Plane Block and Quadratus Lumborum Block in Open Nephrectomy: a Prospective Randomized Clinical Study

October 24, 2024 updated by: Zehra Ipek ARSLAN, Kocaeli University

Comparison of Erector Spina and Quadratus Lumborum in Open Nephrectomy

patients who will undergo elective open nephrectomy will be divided into three groups; the control (PCA), the erector spina plane block, and the quadratus lumborum block. After standard anesthesia induction and monitorization then Bispectral index monitoring will be applied to all patients. Anesthesia will be maintained using sevoflurane in a mixture of oxygen and air. Continuous remifentanil infusion will be used for analgesia. Then patient's numeric rating scales and morphine pca consumptions will be recorded for one day.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

patients who will undergo elective open nephrectomy will be divided into three groups; the control (PCA), the erector spina plane block and the quadratus lumborum block. After standard anesthesia induction and monitorization then Bispectral index monitoring will be applied to all patients. Anesthesia will be maintained using sevoflurane in a mixture of oxygen and air. Continious remifentanil infusion will be used for analgesia. Then patient's numeric rating scales and morphine pca consumptions will be recorded for one day.

Study Type

Interventional

Enrollment (Estimated)

60

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
        • Active, not recruiting
        • Kocaeli University Medical Faculty
      • İzmit, Turkey, 41100
        • Recruiting
        • Kocaeli University Medical Faculty
        • Contact:

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:

  • ASA 1-3
  • open nephrectomy elective patients
  • BMI<35

Exclusion Criteria:

  • ASA 4-5-6
  • Laparoscopic nephrectomy
  • infection at the block side
  • coagulation disorder
  • BMI>35

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
Placebo Comparator: patient controlled analgesia
this group of patients received no block, received only postoperative patient-controlled analgesia with morphine
Procedure: preoperative remifentanil consumption
continuous remifentanil infusion will applied for peroperative analgesia
Procedure: postopeartive controlled anlagesia with morphine
postoperative morphine patient controlled analgesia will be applied for postoperative analgesia
Active Comparator: erector spina plane block
this group of patients received erector spina plane block preoperatively, received only postoperative patient-controlled analgesia with morphine
Procedure: preoperative remifentanil consumption
continuous remifentanil infusion will applied for peroperative analgesia
Procedure: postopeartive controlled anlagesia with morphine
postoperative morphine patient controlled analgesia will be applied for postoperative analgesia
Active Comparator: quadratus lumborum block
this group of patients received erector spina plane block preoperatively, received only postoperative patient-controlled analgesia with morphine
Procedure: preoperative remifentanil consumption
continuous remifentanil infusion will applied for peroperative analgesia
Procedure: postopeartive controlled anlagesia with morphine
postoperative morphine patient controlled analgesia will be applied for postoperative analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative morphine consumption
Time Frame: 24 hour postoperatively
amount of postoperative morphine use of the patient's
24 hour postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
peroperative remifentanil consumptions
Time Frame: 4 hour preoperatively
amount of remifentanil use of the patient's
4 hour preoperatively
numeric rating scale
Time Frame: 24 hour postoperatively
numeric rating scores of the patient's postoepartively
24 hour postoperatively

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)

October 24, 2024

Primary Completion (Estimated)

January 3, 2027

Study Completion (Estimated)

January 3, 2027

Study Registration Dates

First Submitted

March 31, 2023

First Submitted That Met QC Criteria

March 31, 2023

First Posted (Actual)

April 12, 2023

Study Record Updates

Last Update Posted (Actual)

October 26, 2024

Last Update Submitted That Met QC Criteria

October 24, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KAEK / 12bl.01

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

product manufactured in and exported from the U.S.

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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