Intraoperative Placement of Superficial Erector Spinae Plane Block; A New Approach in Spine Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Intraoperative Placement of Superficial Erector Spinae Plane Block in Spine Surgery; An Effective Approach at Enhanced Recovery After Spine Surgery

Conditions
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Postoperative Pain, Spine Deformity, Spine Injury, Spine Fracture, Spine Malformation

Intervention / Treatment
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* Procedure: superficial erector spina plane block
* Procedure: Standard (opioid-based) analgesia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Superficial ESP<br>The investigators performed superficial erector spina plane block to that patient group for postoperative analgesia | Procedure: superficial erector spina plane block<br>* The investigators performed superficial erector spina plane block to that patient group for postoperative analgesia<br>|
| Active Comparator: Control group<br>The investigators performed intravenous opioid infusion with PCA to that patient group for postoperative analgesia | Procedure: Standard (opioid-based) analgesia<br>* The investigators performed intravenous opioid infusion with PCA to that patient group for postoperative analgesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NRS scores of patients | NRS at 1, 6,12, 18, 24, 36, 48th hours | 48 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative 48-hours total morphine consumption | This will be measured only one time by pca device at the 48th hour after surgery. | 48 hours postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative pain, Superficial Erector Spinae Plane Block, Spine Surgery, Local anesthetic