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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04646707
• Other study ID #: 19-5818
• Status: Recruiting
• Phase: N/A
• Start date: February 17, 2020
• Est. completion date: December 30, 2024

Study information

• Verified date: August 2023
• Source: University Health Network, Toronto
• Contact: Michael Dinsmore, MD
• Phone: 416 603 5800
• Email: michael.dinsmore[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: December 30, 2024
• Est. primary completion date: December 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain
• Postoperative

Intervention

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

Locations

Country	Name	City	State
Canada	Toronto Western Hospital?UHN	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Opioids consumption	Patient Opioid/Non-Opioid Pain Medications Diary Card After Surgery	2 weeks and one month