Back to resultsComparison of Postoperative Analgesic Efficacy of the Erector Spina Plane Block and Quadratus Lumborum Block in Open Nephrectomy: a Prospective Randomized Clinical Study
Primary Purpose
Renal Cell Carcinoma
Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
preoperative remifentanil consumption
postopeartive controlled anlagesia with morphine
Sponsored by
About this trial
This is an interventional diagnostic trial for Renal Cell Carcinoma focused on measuring erector spina plane block, quadratus lumborum block, patient controlled analgesia, nephrectomy, analgesia
Eligibility Criteria
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
Sites / Locations
- Kocaeli University School of Medicine
- Kocaeli University Medical Faculty
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
patient controlled analgesia
erector spina plane block
quadratus lumborum block
Arm Description
this group of patients received no block, received only postoperative patient-controlled analgesia with morphine
this group of patients received erector spina plane block preoperatively, received only postoperative patient-controlled analgesia with morphine
this group of patients received erector spina plane block preoperatively, received only postoperative patient-controlled analgesia with morphine
Outcomes
Primary Outcome Measures
postoperative morphine consumption
amount of postoperative morphine use of the patient's
Secondary Outcome Measures
peroperative remifentanil consumptions
amount of remifentanil use of the patient's
numeric rating scale
numeric rating scores of the patient's postoepartively
Full Information
NCT ID
NCT05810571
First Posted
March 31, 2023
Last Updated
March 31, 2023
Sponsor
Kirsehir Ahi Evran University
1. Study Identification
Unique Protocol Identification Number
NCT05810571
Brief Title
Comparison of Postoperative Analgesic Efficacy of the Erector Spina Plane Block and Quadratus Lumborum Block in Open Nephrectomy: a Prospective Randomized Clinical Study
Official Title
Comparison of Erector Spina and Quadratus Lumborum in Open Nephrectomy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
January 3, 2024 (Anticipated)
Study Completion Date
April 3, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran 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
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma
Keywords
erector spina plane block, quadratus lumborum block, patient controlled analgesia, nephrectomy, analgesia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
participant will not know which block applied, and the outcome assessor of the postoperative analgesia will not know
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patient controlled analgesia
Arm Type
Placebo Comparator
Arm Description
this group of patients received no block, received only postoperative patient-controlled analgesia with morphine
Arm Title
erector spina plane block
Arm Type
Active Comparator
Arm Description
this group of patients received erector spina plane block preoperatively, received only postoperative patient-controlled analgesia with morphine
Arm Title
quadratus lumborum block
Arm Type
Active Comparator
Arm Description
this group of patients received erector spina plane block preoperatively, received only postoperative patient-controlled analgesia with morphine
Intervention Type
Procedure
Intervention Name(s)
preoperative remifentanil consumption
Intervention Description
continuous remifentanil infusion will applied for peroperative analgesia
Intervention Type
Procedure
Intervention Name(s)
postopeartive controlled anlagesia with morphine
Intervention Description
postoperative morphine patient controlled analgesia will be applied for postoperative analgesia
Primary Outcome Measure Information:
Title
postoperative morphine consumption
Description
amount of postoperative morphine use of the patient's
Time Frame
24 hour postoperatively
Secondary Outcome Measure Information:
Title
peroperative remifentanil consumptions
Description
amount of remifentanil use of the patient's
Time Frame
4 hour preoperatively
Title
numeric rating scale
Description
numeric rating scores of the patient's postoepartively
Time Frame
24 hour postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Kocaeli University School of Medicine
City
Kocaeli
ZIP/Postal Code
41900
Country
Turkey
Facility Name
Kocaeli University Medical Faculty
City
Kocaeli
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Postoperative Analgesic Efficacy of the Erector Spina Plane Block and Quadratus Lumborum Block in Open Nephrectomy: a Prospective Randomized Clinical Study
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