Comparison of Quadratus Lumborum Block and Erector Spina Plane Block in Nephrectomy

February 3, 2022 updated by: Meryem Onay, Eskisehir Osmangazi University

Comparison of the Effects of Quadratus Lumborum Block (QLB) and Erector Spina Plane Block (ESP) on Postoperative Pain in Open Nephrectomy

Postoperative pain is important due to the limitation of physical functions, delay in recovery of quality of life, long-term opiate use, length of hospital stay, increased care costs and early postoperative pain trigger chronic pain. It is associated with postoperative morbidity. Multimodal analgesia techniques with fascial plan blocks are frequently used.The investigators aimed to evaluate the effect of QLB2 and ESP on postoperative pain scores in nephrectomy surgery, total opiate consumption, initial analgesia requirement, additional analgesia consumption, patient and surgeon satisfaction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

At the end of the operation, patients will be randomly divided into 2 groups as Group E (ESP block) and Group Q (QLB). The blocks will be administered under general anesthesia in lateral position by same anesthesiologist. Group E (ESP block) will be applied 20 ml of %0.25 bupivacaine between the erector spina muscle and transverse process at the 8th thoracic level. Group Q (QLB2 block) will be applied 20 ml of %0.25 bupivacaine at lumbar interfacial triangle (LIFT). At the end of the operation, the patients with a Modified aldreate score ≥9 will be sent from the postoperative anesthesia unit. All patients will be equipped with an IV morphine patient-controlled analgesia (PCA) device. The solution will be prepared such that morphine is 0.5 mg / ml. PCA 1mg bolus dose will be delivered with 10 min lock-out time. In the postoperative period, the patient was evaluated by another researcher who blind to the groups at the 1st and 6th, 12th and 24th hours. Visual pain scores (VAS) in rest and movement, hemodynamic values, morphine consumption, initial analgesic requirement, nausea-vomiting score, ramsey sedation scale, length of hospital stay, patient and surgeon satisfaction, and postoperative complications will be recorded.

Study Type

Interventional

Enrollment (Actual)

40

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 Locations

  • Turkey
    • Eskisehir
      • Odunpazarı, Eskisehir, Turkey, 26040
        • Eskisehir Osmangazi Univercıty

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Partial or radical nephrectomy
  • American Society of Anesthesiologist physical status I-III

Exclusion Criteria:

  • Infection in the incision area
  • Coagulation disorder
  • Known allergy history against to the study drugs
  • Lack of adequate cognitive activity in the use of patient-controlled analgesia and VAS

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ESP block
Intervention: Erector Spina Plane Block will administer with 20 ml of % 0.25 bupivacaine
Procedure: Erector Spina Plane Block
Group E (ESP block) will be applied 20 ml of % 0.25 bupivacaine between the erector spina muscle and transverse process at the 8th thoracic level. The blocks will be administered under general anesthesia in lateral position by the same anesthesiologist.
Other Names:
  • Fascial plane block at nephrectomy
Active Comparator: QLB 2 block
Intervention: Quadratus Lumborum Block 2 will administer with 20 ml of % 0.25 bupivacaine
Procedure: Quadratus Lumborum Block 2
Group Q (QLB2 block) lumbar interfacial triangle (LIFT) will be applied 20 ml of % 0.25 bupivacaine. The blocks will be administered under general anesthesia in lateral position by the same anesthesiologist.
Other Names:
  • Fascial plane block at nephrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of QLB2 and ESP on postoperative pain scores in nephrectomy surgery
Time Frame: 24 hours
Visual analog scale at rest and movement (0 (no pain)-10 (unbearable pain))
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total opiate consumption
Time Frame: 24 hours
Total morphine patient control analgesia prepared 0.5 mg / ml. PCA 1mg bolus dose will be delivered with 10 min lock-out time. Follow up morphine consumption at postoperative 24 hours
24 hours

Collaborators and Investigators

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

Sponsor

Eskisehir Osmangazi University

Investigators

  • Principal Investigator: Meryem Onay, Dr, Eskisehir Osmangazi University Faculty of Medicine

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 (Actual)

July 20, 2020

Primary Completion (Actual)

July 20, 2021

Study Completion (Actual)

January 31, 2022

Study Registration Dates

First Submitted

June 23, 2020

First Submitted That Met QC Criteria

July 6, 2020

First Posted (Actual)

July 7, 2020

Study Record Updates

Last Update Posted (Actual)

February 4, 2022

Last Update Submitted That Met QC Criteria

February 3, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESOGU 2

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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