Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04156581
Recruitment Status : Recruiting
First Posted : November 7, 2019
Last Update Posted : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

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
Opioid Use Pain, Postoperative Drug: Bupivacaine Drug: Dexamethasone Other: Saline Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Erector Spinae Plane Block Versus Conventional Analgesia in Complex Spine Surgery: A Randomized Controlled Trial
Actual Study Start Date : October 14, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


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 HCl and water that can be used as a placebo.




Primary Outcome Measures :
  1. Total Opioid Consumption [ Time Frame: 0-24 hours after surgery (intraoperative + immediately after surgery) ]
    Measured in mean oral morphine equivalents (OME)


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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])

  4. 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)

  5. 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)

  6. Time to Opioid Use [ Time Frame: up to 24 hours after surgery ]
    Time to pressing IV PCA and to requesting first oral opioid

  7. Total Opioid Consumption [ Time Frame: 0-12 hours after surgery (intraoperative + immediately after surgery) ]
    Measured in mean oral morphine equivalents (OME)

  8. Total Opioid Consumption [ Time Frame: 13-24 hours after surgery ]
    Measured in mean oral morphine equivalents (OME)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04156581


Contacts
Layout table for location contacts
Contact: Avery Schnell, B.S. (646) 797-8536 SchnellA@HSS.edu
Contact: Audrey Tseng, B.S. (646) 797-8535 TsengA@HSS.edu

Locations
Layout table for location information
United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: Avery Schnell, B.S.    646-797-8536    SchnellA@HSS.edu   
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
Layout table for investigator information
Principal Investigator: Ellen Soffin, MD PhD Hospital for Special Surgery, New York

Layout table for additonal information
Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT04156581     History of Changes
Other Study ID Numbers: 2019-1282
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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).
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code
Time Frame: Beginning 3 months and ending 5 years following article publication.
Access Criteria: Researchers who provide a methodologically sound proposal, in order to achieve aims in the approved proposal.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Dexamethasone
Dexamethasone acetate
Bupivacaine
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents