Intraoperative Placement of Superficial Erector Spinae Plane Block; A New Approach in Spine Surgery
Primary Purpose
Postoperative Pain, Spine Deformity, Spine Injury
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
superficial erector spina plane block
Standard (opioid-based) analgesia
Sponsored by
About this trial
This is an interventional supportive care trial for Postoperative Pain focused on measuring Postoperative pain, Superficial Erector Spinae Plane Block, Spine Surgery, Local anesthetic
Eligibility Criteria
Inclusion Criteria:
- Ages of 18-65
- Patients who will undergo spine surgery (at least two level)
- ASA I-II-III patients
Exclusion Criteria:
- Clinically known local anesthetic allergy
- Morbid obesity (body mass index>40 kg m2)
- Clinically diagnosis of opioid, alcohol and substance dependence
- Clinically diagnosis of psychiatric disease
- Coagulopathy
- Patients with ASA IV-V
- Single level surgery
Sites / Locations
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Superficial ESP
Control group
Arm Description
The investigators performed superficial erector spina plane block to that patient group for postoperative analgesia
The investigators performed intravenous opioid infusion with PCA to that patient group for postoperative analgesia
Outcomes
Primary Outcome Measures
NRS scores of patients
NRS at 1, 6,12, 18, 24, 36, 48th hours
Secondary Outcome Measures
Postoperative 48-hours total morphine consumption
This will be measured only one time by pca device at the 48th hour after surgery.
Full Information
NCT ID
NCT05244031
First Posted
February 8, 2022
Last Updated
February 16, 2022
Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05244031
Brief Title
Intraoperative Placement of Superficial Erector Spinae Plane Block; A New Approach in Spine Surgery
Official Title
Intraoperative Placement of Superficial Erector Spinae Plane Block in Spine Surgery; An Effective Approach at Enhanced Recovery After Spine Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
May 10, 2021 (Actual)
Primary Completion Date
February 7, 2022 (Actual)
Study Completion Date
February 7, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Major spine surgery causes severe postoperative pain. The primary objective of this randomized controlled study is to compare the effect of ultrasound (US)-guided superficial erector spinae plane (ESP) block on 48-hour postoperative cumulative opioid requirements with standard (opioid-based) analgesia.
Detailed Description
46 patients (ASA I-II-III) between 18 and 65 years of age, who were to undergo spine surgery, were randomized and divided into two groups. (23 patients in each of the control and superficial ESP groups). Superficial ESP block was performed for SESP group and standard (opioid-based) analgesia performed in the control group. Postoperative analgesia was provided by intravenous morphine infusion using a patient-controlled analgesia device. Postoperative numeric rating scale values were the primary outcome measure. 24-hour total morphine consumption was secondary outcome measure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Spine Deformity, Spine Injury, Spine Fracture, Spine Malformation
Keywords
Postoperative pain, Superficial Erector Spinae Plane Block, Spine Surgery, Local anesthetic
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Superficial ESP
Arm Type
Active Comparator
Arm Description
The investigators performed superficial erector spina plane block to that patient group for postoperative analgesia
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
The investigators performed intravenous opioid infusion with PCA to that patient group for postoperative analgesia
Intervention Type
Procedure
Intervention Name(s)
superficial erector spina plane block
Intervention Description
The investigators performed superficial erector spina plane block to that patient group for postoperative analgesia
Intervention Type
Procedure
Intervention Name(s)
Standard (opioid-based) analgesia
Intervention Description
The investigators performed intravenous opioid infusion with PCA to that patient group for postoperative analgesia
Primary Outcome Measure Information:
Title
NRS scores of patients
Description
NRS at 1, 6,12, 18, 24, 36, 48th hours
Time Frame
48 hours postoperatively
Secondary Outcome Measure Information:
Title
Postoperative 48-hours total morphine consumption
Description
This will be measured only one time by pca device at the 48th hour after surgery.
Time Frame
48 hours postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ages of 18-65
Patients who will undergo spine surgery (at least two level)
ASA I-II-III patients
Exclusion Criteria:
Clinically known local anesthetic allergy
Morbid obesity (body mass index>40 kg m2)
Clinically diagnosis of opioid, alcohol and substance dependence
Clinically diagnosis of psychiatric disease
Coagulopathy
Patients with ASA IV-V
Single level surgery
Facility Information:
Facility Name
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
City
Istanbul
State/Province
Bakirkoy
ZIP/Postal Code
34147
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Intraoperative Placement of Superficial Erector Spinae Plane Block; A New Approach in Spine Surgery
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