Back to resultsErector Spina Plane Block for Multilevel Major Spinal Surgery
Primary Purpose
Pain, Post Operative Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Erector spinae plane block
Control
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring Pain, postoperative analgesia, Erector spinae plane block, posterior spinal instrumentation
Eligibility Criteria
Inclusion Criteria: ASA I-III patients Agreed to participate in the study Exclusion Criteria: Patients with infection at the injection site Coagulopathy Allergy to amide-type local anesthetics History of peripheral neuropathy Hepatic and/or renal failure Refusing the procedure Patients with heart disease Patients who have previously undergone surgery from the same area
Sites / Locations
- Kahramanmaras Sutcu Imam University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
Control group
Erector spinae plane block
Arm Description
No block was performed
Erector spinae plane block was performed, morphine was administered with patient-controlled analgesia (PCA) and all patients were followed in the ward.
Outcomes
Primary Outcome Measures
opioid consumption
The amount of morphine consumed in milligrams in the first 24 hours was determined with a patient-controlled analgesia pump.
Secondary Outcome Measures
Full Information
NCT ID
NCT05983393
First Posted
August 1, 2023
Last Updated
October 6, 2023
Sponsor
Kahramanmaras Sutcu Imam University
1. Study Identification
Unique Protocol Identification Number
NCT05983393
Brief Title
Erector Spina Plane Block for Multilevel Major Spinal Surgery
Official Title
Effect of Ultrasound-guided Bilateral Erector Spina Plan Block for Postoperative Analgesia in Patients Undergoing Multilevel Posterior Spinal Instrumentation.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
August 7, 2023 (Actual)
Study Completion Date
August 7, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kahramanmaras Sutcu Imam 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
Erector spinae plane (ESP) block is an interfacial plane block with visceral and somatic analgesic activity at paraspinal muscles. This study aims to examine the postoperative analgesic efficacy of ESP block in patients undergoing posterior spinal instrumentation
Detailed Description
Postoperative patient-controlled analgesia in the ESP group and control group will be compared with 24-hour morphine consumption and NRS scores at different time points. In addition, the need for rescue analgesics and patient satisfaction will be evaluated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Post Operative Pain
Keywords
Pain, postoperative analgesia, Erector spinae plane block, posterior spinal instrumentation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
No block was performed
Arm Title
Erector spinae plane block
Arm Type
Active Comparator
Arm Description
Erector spinae plane block was performed, morphine was administered with patient-controlled analgesia (PCA) and all patients were followed in the ward.
Intervention Type
Procedure
Intervention Name(s)
Erector spinae plane block
Intervention Description
Erector spinae plane block was performed
Intervention Type
Procedure
Intervention Name(s)
Control
Intervention Description
Erector spinae plane block was not applied.
Primary Outcome Measure Information:
Title
opioid consumption
Description
The amount of morphine consumed in milligrams in the first 24 hours was determined with a patient-controlled analgesia pump.
Time Frame
up to 24 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
ASA I-III patients
Agreed to participate in the study
Exclusion Criteria:
Patients with infection at the injection site
Coagulopathy Allergy to amide-type local anesthetics
History of peripheral neuropathy
Hepatic and/or renal failure
Refusing the procedure
Patients with heart disease
Patients who have previously undergone surgery from the same area
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gökce Gişi
Organizational Affiliation
Kahramanmaras Sutcu Imam Universty
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gözen Öksüz
Organizational Affiliation
Kahramanmaras Sutcu Imam Universty
Official's Role
Study Director
Facility Information:
Facility Name
Kahramanmaras Sutcu Imam University Hospital
City
Kahramanmaras
ZIP/Postal Code
46100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Erector Spina Plane Block for Multilevel Major Spinal Surgery
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