ESPB-Spine: Erector Spinae Plane Block Versus Conventional Analgesia in Complex Spine Surgery
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: ESPB with Bupivacaine and Dexamethasone 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
Bupivacaine is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures.
Drug: Dexamethasone
Dexamethasone is a corticosteroid that reduces inflammation.
|
| Placebo Comparator: ESPB with saline placebo 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
Saline is a mixture of NaCl and water that can be used as a placebo.
|
Outcome Measures
Primary Outcome Measures
- Total Opioid Consumption [0-24 hours after surgery (intraoperative + immediately after surgery)]
Measured in mean oral morphine equivalents (OME)
Secondary Outcome Measures
- Pain Scores at Rest [at baseline (holding area), PACU (hour 0), hour 6, 12, and 24 hours after surgery]
Measured by Numeric Rating Scale (NRS) pain at rest (0 being no pain and 10 being as bad as you can imagine)
- Pain Scores with Physical Therapy [on post-operative physical therapy day 0, 1, and 2]
Measured by Numeric Rating Scale (NRS) pain with movement (0 being no pain and 10 being as bad as you can imagine)
- Quality of Recovery: QoR15 [at baseline (holding area), 24 and 72 hours after surgery]
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])
- Opioid Related Side Effects [at 24 hours after surgery]
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)
- Blinding Assessment [at 72 hours after surgery]
Measured by bang blinding index (choose between two treatment arms and provide explanation as to why arm was chosen)
- Time to Opioid Use [up to 24 hours after surgery]
Time to pressing IV PCA and to requesting first oral opioid
- Total Opioid Consumption [0-12 hours after surgery (intraoperative + immediately after surgery)]
Measured in mean oral morphine equivalents (OME)
- Total Opioid Consumption [13-24 hours after surgery]
Measured in mean oral morphine equivalents (OME)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 18-80
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Planned primary complex spine surgery: >2 level- lumbar and/or thoraco-lumbar spine fusion with or without decompression
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Planned stand-alone posterior surgical approach
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Able to follow study protocol
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Able to communicate in English (outcome questionnaires validated in English)
Exclusion Criteria:
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Age <18 or >80
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Revision surgery
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BMI > 35
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planned prolonged intubation/intubation overnight on night of surgery
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Unable to communicate in English
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History of chronic pain condition requiring gabapentin/pregabalin/antidepressant medication longer than 3 months
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Opioid tolerance (>60 OME daily for >2 weeks)
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Allergy, intolerance or contraindication to any protocol component/study medication/technique
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Patient refusal of regional analgesia (ESPB)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital for Special Surgery | New York | New York | United States | 10021 |
Sponsors and Collaborators
- Hospital for Special Surgery, New York
Investigators
- Principal Investigator: Ellen Soffin, MD PhD, Hospital for Special Surgery, New York
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2019-1282