Erector Spinae Plane Block Versus Conventional Analgesia in Complex Spine Surgery
NCT ID: NCT04156581
Last Updated: 2024-12-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
46 participants
INTERVENTIONAL
2019-11-19
2022-06-18
Brief Summary
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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.
Detailed Description
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As in other orthopedic subspecialty surgeries, enhanced recovery pathways (ERPs) are now being described in spine surgery (Wang 2017; Soffin 2018; Soffin 2019a; Ali 2019). Published data emphasizes the importance of opioid-sparing MMA to achieve analgesia and minimize opioid-related side effects. However, with the exception of a report from our group, none include regional analgesia or field blocks as an element of care (Soffin 2019b). Further, comparative research regarding the benefits of regional analgesia within standardized ERPs is lacking for other surgical modalities - even within subspecialties where the evidence base to support such trials is more advanced. These deficits highlight an opportunity to demonstrate the unique advantages of regional analgesia over and above that which can be provided by conventional oral and/or intravenous MMA.
Ultrasound-guided erector spinae plane block (ESPB) may represent a novel opportunity to apply regional analgesia to patients undergoing spine surgery. First described in 2016, ESPB provides analgesia by depositing local anesthetic deep to the erector spinae muscles (Forero 2016). Studies have not completely defined the mechanism of the block, but the target of the local anesthetic has been proposed to be unmyelinated C fibers / sensory cell bodies within the dorsal root ganglia (Ivanusic 2018).
Since its introduction, hundreds of case reports with a wide spectrum of indications have described ESPB as a useful analgesic adjunct for a wide range of indications (Tsui 2019). The feasibility of ESPBs in spine surgery has likewise been suggested in case reports (Almeida 2019; Chin 2019), case series (Melvin 2018; Singh 2018) and retrospective cohort studies (Ueshima 2019). Each conclude significant opioid-sparing capacity and improved NRS pain scores in patients who receive ESPB for a variety of spine surgery procedures.
More recently, results from 2 RCTs describing outcomes after ESPB for lumbar decompression have been reported. In the first, 60 patients were randomized to receive bilateral ESPB or no intervention (Yayik 2019). NRS scores and tramadol consumption were significantly lower in the first 24 hours after surgery, and the time to requesting opioid analgesia was significantly longer in patients were received ESPB. In the second RCT, postoperative morphine consumption was lower in patients who received ESPB compared to patients who did not receive ESPB (Singh, 2019). NRS scores were lower up to 6 hours after surgery in the ESPB group, and patient satisfaction scores were higher.
These preliminary RCTs are promising; however, both suffer from methodological flaws, including lack of power, inadequate blinding, and incomplete standardization of other intra- and post-operative analgesics.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Bupivacaine
Bupivacaine is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures.
Dexamethasone
Dexamethasone is a corticosteroid that reduces inflammation.
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.
Saline
Saline is a mixture of NaCl and water that can be used as a placebo.
Interventions
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Bupivacaine
Bupivacaine is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures.
Dexamethasone
Dexamethasone is a corticosteroid that reduces inflammation.
Saline
Saline is a mixture of NaCl and water that can be used as a placebo.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
80 Years
ALL
No
Sponsors
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Hospital for Special Surgery, New York
OTHER
Responsible Party
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Principal Investigators
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Ellen Soffin, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital for Special Surgery, New York
Locations
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Hospital for Special Surgery
New York, New York, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2019-1282
Identifier Type: -
Identifier Source: org_study_id