Effect of Erector Spinae (ESP) Block on Opioid Reduction and Enhanced Recovery After Posterior Cervical Spine Surgery

Patients undergoing spine surgery frequently experience significant pain after surgery. This can limit patient activity and hinder rehabilitation. If inadequately treated, severe pain can result in emotional and psychological distress and ultimately impact long-term function, and increase the risk of developing pain that lasts longer than six months associated with depression, anxiety and disability.

More specifically, Erector Spinae Plane (ESP) block is a recently described plane block designed to block the dorsal and ventral rami of the thoracic spinal nerves. It has shown to be an effective modality for postoperative pain management as a part of multimodal analgesia in spinal surgery.

Study Overview

• Status: Recruiting
• Conditions: Pain; Postoperative
• Intervention / Treatment: Drug: Erector Spinae (ESP) Block with Lidocaine/Bupivacaine; Drug: Erector Spinae (ESP) Block with placebo

Detailed Description

Patients undergoing spine surgery frequently experience significant pain after surgery. Currently, standard management of acute pain after surgery consists mainly of systemic opioid narcotics and nonsteroidal anti-inflammatory drugs (NSAIDs). Generally, opiates and NSAIDs are not completely effective at managing pain, and they carry significant risk of addiction and overdose, particularly with prolonged or increased dosing. The concept of multimodal or ''balanced'' analgesia is rapidly becoming the 'standard of care' for preventing post-operative pain. It consists of the use of combinations of analgesics of different classes with different sites of action in an attempt to provide superior pain relief with reduced analgesic related side effects. Local anesthetic injection to block specific nerves has been widely recognized as a useful adjunct in a multimodal approach to postoperative pain management.

Erector Spinae Plane (ESP) block is a recently described plane block designed to block the dorsal and ventral rami of the thoracic spinal nerves. It has shown to be an effective modality for postoperative pain management as a part of multimodal analgesia in spinal surgery.

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Dinsmore, MD; Phone Number: 2269 416 603 5800; Email: michael.dinsmore@uhn.ca
• Study Contact Backup: Name: Ki Jinn Chin, MD; Phone Number: 2269 416 603 5800

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 2S8
      • Recruiting
      • Toronto Western Hospital?UHN
      • Contact: Michael Dinsmore, MD
      • Contact: Emad Al Azazi, MD; Phone Number: 6237 416-603-5800; Email: emad.alazazi@uhnresearch.ca

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

All adult patients aged 18-80 years with ASA class I - III undergoing posterior cervical (C3-T2) decompression and instrumented fusion for cervical stenosis in prone position.

Exclusion Criteria:

1. In patients who are allergic to local anesthetics.
2. ASA IV patients
3. Lack of informed consent
4. Pregnant patient.
5. Fracture cervical spine
6. Extradural or intradural cervical tumors
7. Surgery of C1 and C2 spine

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group; Bilateral ESP block at T1 level with 20 ml of 1:1 mixture (2% Lidocaine: 0.5% bupivacaine)	Drug: Erector Spinae (ESP) Block with Lidocaine/Bupivacaine; Bilateral ESP block at T1 level with 20 ml of 1:1 mixture (2% Lidocaine: 0.5% bupivacaine); Other Names: Study group
Placebo Comparator: Placebo Group; Bilateral ESP block at T1 level with 20 ml of 0.9% normal saline	Drug: Erector Spinae (ESP) Block with placebo; Bilateral ESP block at T1 level with 20 ml of 0.9% normal saline; Other Names: Placebo group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Recovery 40 Questionnaire	the global Quality of Recovery-40 aggregate score is a scale from (1 to 5, where: 1 = very poor and 5 = excellent)	24 hours after surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	is a visual analog scale from (1 to 10, where: 1 is the mildest and 10 the worst possible)	2 weeks and one month
Opioids consumption	Patient Opioid/Non-Opioid Pain Medications Diary Card After Surgery	2 weeks and one month

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Michael Dinsmore, MD, University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2020
• Primary Completion (Estimated): December 17, 2023
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: November 5, 2019
• First Submitted That Met QC Criteria: November 23, 2020
• First Posted (Actual): November 30, 2020

Study Record Updates

• Last Update Posted (Actual): August 28, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Recovery; Opioid; Postoperative; Enhanced; Reduction
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Bupivacaine
• Other Study ID Numbers: 19-5818

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No