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

Not Applicable

Recruiting

• Conditions: Postoperative; Pain
• Interventions: Drug: Erector Spinae (ESP) Block with placebo; Drug: Erector Spinae (ESP) Block with Lidocaine/Bupivacaine

• Registration Number: NCT04646707
• Lead Sponsor: University Health Network, Toronto

Brief Summary

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.

Study Timeline

• Study First Submitted: 2019-11-05
• Study Start: 2020-02-17
• Study First Submitted QC: 2020-11-23
• Study First Posted: 2020-11-30
• Status Verified: 2023-08
• Last Update Submitted: 2024-05-17
• Last Update Posted: 2024-05-20
• Primary Completion: 2025-12-17
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 52

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Erector Spinae (ESP) Block with placebo	Bilateral ESP block at T1 level with 20 ml of 0.9% normal saline
Study group	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)

Primary Outcome Measures

Name	Time	Method
Quality of Recovery 40 Questionnaire	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 Outcome Measures

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

Trial Locations

Locations (1)

Toronto Western Hospital?UHN; 🇨🇦 Toronto, Ontario, Canada