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Recruiting NCT04646707

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

No phase Interventional Postoperative Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Erector Spinae (ESP) Block with Lidocaine/Bupivacaine, Erector Spinae (ESP) Block with placebo.
Who it may be relevant to
Registry conditions: Postoperative, Pain. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

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.

Interventions

  • 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)
  • Drug Erector Spinae (ESP) Block with placebo
    Bilateral ESP block at T1 level with 20 ml of 0.9% normal saline

Primary outcome measures

  • Quality of Recovery 40 Questionnaire [Time frame: 24 hours after surgery.]
Secondary outcome measures (2)
  • Postoperative pain [Time frame: 2 weeks and one month]
  • Opioids consumption [Time frame: 2 weeks and one month]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Toronto Western Hospital?UHN — Toronto

Identifiers

NCT: NCT04646707 · 19-5818

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗