NCT04459624

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
13 days until next milestone

Study Start

First participant enrolled

July 20, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

February 4, 2022

Status Verified

February 1, 2022

Enrollment Period

1 year

First QC Date

June 23, 2020

Last Update Submit

February 3, 2022

Conditions

Keywords

Erector Spina Plan BlockQuadratus Lumborum BlockNephrectomyPostoperative Pain

Outcome Measures

Primary Outcomes (1)

  • Effect of QLB2 and ESP on postoperative pain scores in nephrectomy surgery

    Visual analog scale at rest and movement (0 (no pain)-10 (unbearable pain))

    24 hours

Secondary Outcomes (1)

  • Total opiate consumption

    24 hours

Study Arms (2)

ESP block

ACTIVE COMPARATOR

Intervention: Erector Spina Plane Block will administer with 20 ml of % 0.25 bupivacaine

Procedure: Erector Spina Plane Block

QLB 2 block

ACTIVE COMPARATOR

Intervention: Quadratus Lumborum Block 2 will administer with 20 ml of % 0.25 bupivacaine

Procedure: Quadratus Lumborum Block 2

Interventions

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.

Also known as: Fascial plane block at nephrectomy
ESP block

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.

Also known as: Fascial plane block at nephrectomy
QLB 2 block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eskisehir Osmangazi Univercıty

Odunpazari, Eskişehir, 26040, Turkey (Türkiye)

Location

Related Publications (4)

  • Aksu C, Sen MC, Akay MA, Baydemir C, Gurkan Y. Erector Spinae Plane Block vs Quadratus Lumborum Block for pediatric lower abdominal surgery: A double blinded, prospective, and randomized trial. J Clin Anesth. 2019 Nov;57:24-28. doi: 10.1016/j.jclinane.2019.03.006. Epub 2019 Mar 6.

    PMID: 30851499BACKGROUND
  • Ueshima H, Otake H, Lin JA. Ultrasound-Guided Quadratus Lumborum Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:2752876. doi: 10.1155/2017/2752876. Epub 2017 Jan 3.

    PMID: 28154824BACKGROUND
  • Oksuz G, Bilal B, Gurkan Y, Urfalioglu A, Arslan M, Gisi G, Oksuz H. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Children Undergoing Low Abdominal Surgery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):674-679. doi: 10.1097/AAP.0000000000000645.

    PMID: 28759502BACKGROUND
  • Yousef NK. Quadratus Lumborum Block versus Transversus Abdominis Plane Block in Patients Undergoing Total Abdominal Hysterectomy: A Randomized Prospective Controlled Trial. Anesth Essays Res. 2018 Jul-Sep;12(3):742-747. doi: 10.4103/aer.AER_108_18.

    PMID: 30283187BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativePostoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Meryem Onay, Dr

    Eskisehir Osmangazi University Faculty Of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
In the postoperative period, the effectiveness and safety of the block will be evaluated by another researcher (blind) who does not know which group the patient is in.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Group E: ESP block will be applied at the end of the operation. Patients will receive paracetamol 1gr 4 \* 1 and tramadol 1mg/kg 30 minutes before the end of the operation. All patients will undergo IV morphine patient-controlled analgesia (PCA). Pain, opioid consumption, hemodynamic parameters and complications will be monitored in the first 24 hours in the postoperative period. Group Q: QLB2 block will be applied at the end of the operation. Patients will receive paracetamol 1gr 4 \* 1 and tramadol 1mg / kg 30 minutes before the end of the operation. All patients will undergo IV morphine patient-controlled analgesia (PCA). Pain, opioid consumption, hemodynamic parameters and complications will be monitored in the first 24 hours in the postoperative period.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist Doctor-Anesthesiologist

Study Record Dates

First Submitted

June 23, 2020

First Posted

July 7, 2020

Study Start

July 20, 2020

Primary Completion

July 20, 2021

Study Completion

January 31, 2022

Last Updated

February 4, 2022

Record last verified: 2022-02

Locations