Erector Spinae Plane Block Versus Conventional Analgesia in Complex Spine Surgery

Overview

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.

Full Title of Study: “Erector Spinae Plane Block Versus Conventional Analgesia in Complex Spine Surgery: A Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 2020

Interventions

  • 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.
  • Other: Saline
    • Saline is a mixture of HCl and water that can be used as a placebo.

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Total Opioid Consumption
    • Time Frame: 0-24 hours after surgery (intraoperative + immediately after surgery)
    • Measured in mean oral morphine equivalents (OME)

Secondary Measures

  • Pain Scores at Rest
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: up to 24 hours after surgery
    • Time to pressing IV PCA and to requesting first oral opioid
  • Total Opioid Consumption
    • Time Frame: 0-12 hours after surgery (intraoperative + immediately after surgery)
    • Measured in mean oral morphine equivalents (OME)
  • Total Opioid Consumption
    • Time Frame: 13-24 hours after surgery
    • Measured in mean oral morphine equivalents (OME)

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospital for Special Surgery, New York
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ellen Soffin, MD PhD, Principal Investigator, Hospital for Special Surgery, New York
  • Overall Contact(s)
    • Avery Schnell, B.S., (646) 797-8536, SchnellA@HSS.edu

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