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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Postoperative, Pain

Intervention / Treatment
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* Drug: Erector Spinae (ESP) Block with Lidocaine/Bupivacaine
* Drug: Erector Spinae (ESP) Block with placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a double blind, randomized control clinical trial.
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opioid, Reduction, Enhanced, Postoperative, Recovery