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NCT Number: NCT04646707

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.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto Western Hospital?UHN

Toronto, Ontario, M5T 2S8, Canada

Location status: Recruiting

Location contact

Emad Al Azazi, MD

CONTACT

[email protected]

416-603-5800 ext. 6237

Michael Dinsmore, MD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • In patients who are allergic to local anesthetics.
  • ASA IV patients
  • Lack of informed consent
  • Pregnant patient.
  • Fracture cervical spine
  • Extradural or intradural cervical tumors
  • Surgery of C1 and C2 spine

Treatment and study plan

Erector Spinae (ESP) Block with Lidocaine/Bupivacaine

Drug

Bilateral ESP block at T1 level with 20 ml of 1:1 mixture (2% Lidocaine: 0.5% bupivacaine)

Other names: Study group

Erector Spinae (ESP) Block with placebo

Drug

Bilateral ESP block at T1 level with 20 ml of 0.9% normal saline

Other names: Placebo group

Primary outcomes

  1. Quality of Recovery 40 Questionnaire

    Time frame: 24 hours after surgery.

    the global Quality of Recovery-40 aggregate score is a scale from (1 to 5, where: 1 = very poor and 5 = excellent)

Secondary outcomes

  1. Postoperative pain

    Time frame: 2 weeks and one month

    is a visual analog scale from (1 to 10, where: 1 is the mildest and 10 the worst possible)

  2. Opioids consumption

    Time frame: 2 weeks and one month

    Patient Opioid/Non-Opioid Pain Medications Diary Card After Surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Ki Jinn Chin, MD

CONTACT

416 603 5800 ext. 2269

Michael Dinsmore, MD

CONTACT

[email protected]

416 603 5800 ext. 2269

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Nov 30, 2020
Registry last updated
Jan 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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