Erector Spinae Plane Block Versus Conventional Analgesia in Complex Spine Surgery (ESPB-Spine)

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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Opioid Use
• Intervention / Treatment: Drug: Bupivacaine; Drug: Dexamethasone; Other: Saline

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Hospital for Special Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York
• Investigators: Principal Investigator: Ellen Soffin, MD, PhD, Hospital for Special Surgery, New York

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2019
• Primary Completion (Actual): June 18, 2022
• Study Completion (Actual): June 18, 2022

Study Registration Dates

• First Submitted: October 25, 2019
• First Submitted That Met QC Criteria: November 6, 2019
• First Posted (Actual): November 7, 2019

Study Record Updates

• Last Update Posted (Actual): September 26, 2022
• Last Update Submitted That Met QC Criteria: September 23, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Anesthetics, Local; Dexamethasone; Bupivacaine
• Other Study ID Numbers: 2019-1282

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Certain individual participant data will be available. Individual participant data that underlie the results reported in a future article, after deidentification (text, tables, figures, appendices).
• IPD Sharing Time Frame: Beginning 3 months and ending 5 years following article publication.
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal, in order to achieve aims in the approved proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No