Intraoperative Placement of Superficial Erector Spinae Plane Block; A New Approach in Spine Surgery
1 other identifier
interventional
46
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable postoperative-pain
Started May 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 7, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 7, 2022
CompletedFirst Submitted
Initial submission to the registry
February 8, 2022
CompletedFirst Posted
Study publicly available on registry
February 17, 2022
CompletedMarch 3, 2022
February 1, 2022
9 months
February 8, 2022
February 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
NRS scores of patients
NRS at 1, 6,12, 18, 24, 36, 48th hours
48 hours postoperatively
Secondary Outcomes (1)
Postoperative 48-hours total morphine consumption
48 hours postoperatively
Study Arms (2)
Superficial ESP
ACTIVE COMPARATORThe investigators performed superficial erector spina plane block to that patient group for postoperative analgesia
Control group
ACTIVE COMPARATORThe investigators performed intravenous opioid infusion with PCA to that patient group for postoperative analgesia
Interventions
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
Eligibility Criteria
You may qualify if:
- Ages of 18-65
- Patients who will undergo spine surgery (at least two level)
- ASA I-II-III patients
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Istanbul, Bakirkoy, 34147, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
February 8, 2022
First Posted
February 17, 2022
Study Start
May 10, 2021
Primary Completion
February 7, 2022
Study Completion
February 7, 2022
Last Updated
March 3, 2022
Record last verified: 2022-02