Erector Spinae Plane Block Versus Conventional Analgesia in Complex Spine Surgery

Study Overview
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Brief Summary
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Enhanced recovery pathways (ERPs) emphasize evidence-based, multimodal anesthetic and analgesic choices to minimize opioid consumption while providing adequate pain control after surgery. Although ERPs for spine surgery are now being described, few pathways include regional analgesia. The Erector Spinae Plane Block (ESPB) may represent a novel opportunity to incorporate regional analgesia into ERPs for spine surgery. To date, there is minimal data to support the utility of ESPB in spine surgery, and this block has not yet been evaluated in complex spine surgery. This study seeks to see whether ESPB will reduce opioid consumption and pain scores, and improve patient recovery during the first 24 hours after complex spine surgery when included in a comprehensive ERP.

Official Title
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Erector Spinae Plane Block Versus Conventional Analgesia in Complex Spine Surgery: A Randomized Controlled Trial

Conditions
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Opioid Use, Pain, Postoperative

Intervention / Treatment
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* Drug: Bupivacaine
* Drug: Dexamethasone
* Other: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-80 Planned primary complex spine surgery: >2 level- lumbar and/or thoraco-lumbar spine fusion with or without decompression Planned stand-alone posterior surgical approach Able to follow study protocol Able to communicate in English (outcome questionnaires validated in English) Exclusion Criteria: Age <18 or >80 Revision surgery BMI > 35 planned prolonged intubation/intubation overnight on night of surgery Unable to communicate in English History of chronic pain condition requiring gabapentin/pregabalin/antidepressant medication longer than 3 months Opioid tolerance (>60 OME daily for >2 weeks) Allergy, intolerance or contraindication to any protocol component/study medication/technique Patient refusal of regional analgesia (ESPB)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ESPB with Bupivacaine and Dexamethasone<br>23 complex spine surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with 0.375% bupivacaine plus 2 mg preservative free dexamethasone, 25-30 mL total per side according to patient weight. | Drug: Bupivacaine<br>* Bupivacaine is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures.<br>Drug: Dexamethasone<br>* Dexamethasone is a corticosteroid that reduces inflammation.<br>|
| Placebo Comparator: ESPB with saline placebo<br>23 complex spine surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with saline placebo, 25-30 mL total per side according to patient weight. | Other: Saline<br>* Saline is a mixture of NaCl and water that can be used as a placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Opioid Consumption | Measured in mean oral morphine equivalents (OME) | 0-24 hours after surgery (intraoperative + immediately after surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores at Rest | Measured by Numeric Rating Scale (NRS) pain at rest (0 being no pain and 10 being as bad as you can imagine) | at baseline (holding area), PACU (hour 0), hour 6, 12, and 24 hours after surgery | 
| Pain Scores with Physical Therapy | Measured by Numeric Rating Scale (NRS) pain with movement (0 being no pain and 10 being as bad as you can imagine) | on post-operative physical therapy day 0, 1, and 2 | 
| Quality of Recovery: QoR15 | Measured by QoR15 (Part A: 0 to 10 where 0=none of the time [poor] and 10=all the time [excellent]; Part B: 0 to 10 where 10=none of the time [poor] and 0=all the time [excellent]) | at baseline (holding area), 24 and 72 hours after surgery | 
| Opioid Related Side Effects | Measured by 10 symptom ORSDS (symptom frequency: rarely to almost constantly; symptom severity: slight to very severe; symptom distress: not at all to very much) | at 24 hours after surgery | 
| Blinding Assessment | Measured by bang blinding index (choose between two treatment arms and provide explanation as to why arm was chosen) | at 72 hours after surgery | 
| Time to Opioid Use | Time to pressing IV PCA and to requesting first oral opioid | up to 24 hours after surgery | 
| Total Opioid Consumption | Measured in mean oral morphine equivalents (OME) | 0-12 hours after surgery (intraoperative + immediately after surgery) | 
| Total Opioid Consumption | Measured in mean oral morphine equivalents (OME) | 13-24 hours after surgery |