Comparison of Quadratus Lumborum Block and Erector Spina Plane Block in Nephrectomy
Primary Purpose
Pain, Postoperative, Postoperative Complications
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Erector Spina Plane Block
Quadratus Lumborum Block 2
Sponsored by
About this trial
This is an interventional other trial for Pain, Postoperative focused on measuring Erector Spina Plan Block, Quadratus Lumborum Block, Nephrectomy, Postoperative Pain
Eligibility Criteria
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
Sites / Locations
- Eskisehir Osmangazi Univercıty
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
ESP block
QLB 2 block
Arm Description
Intervention: Erector Spina Plane Block will administer with 20 ml of % 0.25 bupivacaine
Intervention: Quadratus Lumborum Block 2 will administer with 20 ml of % 0.25 bupivacaine
Outcomes
Primary Outcome Measures
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))
Secondary Outcome Measures
Total opiate consumption
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
Full Information
NCT ID
NCT04459624
First Posted
June 23, 2020
Last Updated
February 3, 2022
Sponsor
Eskisehir Osmangazi University
1. Study Identification
Unique Protocol Identification Number
NCT04459624
Brief Title
Comparison of Quadratus Lumborum Block and Erector Spina Plane Block in Nephrectomy
Official Title
Comparison of the Effects of Quadratus Lumborum Block (QLB) and Erector Spina Plane Block (ESP) on Postoperative Pain in Open Nephrectomy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
July 20, 2020 (Actual)
Primary Completion Date
July 20, 2021 (Actual)
Study Completion Date
January 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eskisehir Osmangazi University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Postoperative Complications
Keywords
Erector Spina Plan Block, Quadratus Lumborum Block, Nephrectomy, Postoperative Pain
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ESP block
Arm Type
Active Comparator
Arm Description
Intervention: Erector Spina Plane Block will administer with 20 ml of % 0.25 bupivacaine
Arm Title
QLB 2 block
Arm Type
Active Comparator
Arm Description
Intervention: Quadratus Lumborum Block 2 will administer with 20 ml of % 0.25 bupivacaine
Intervention Type
Procedure
Intervention Name(s)
Erector Spina Plane Block
Other Intervention Name(s)
Fascial plane block at nephrectomy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Quadratus Lumborum Block 2
Other Intervention Name(s)
Fascial plane block at nephrectomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effect of QLB2 and ESP on postoperative pain scores in nephrectomy surgery
Description
Visual analog scale at rest and movement (0 (no pain)-10 (unbearable pain))
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Total opiate consumption
Description
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
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meryem Onay, Dr
Organizational Affiliation
Eskisehir Osmangazi University Faculty Of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eskisehir Osmangazi Univercıty
City
Odunpazarı
State/Province
Eskisehir
ZIP/Postal Code
26040
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
30851499
Citation
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.
Results Reference
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PubMed Identifier
28154824
Citation
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.
Results Reference
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PubMed Identifier
28759502
Citation
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.
Results Reference
background
PubMed Identifier
30283187
Citation
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.
Results Reference
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Comparison of Quadratus Lumborum Block and Erector Spina Plane Block in Nephrectomy
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