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

NCT ID: NCT04646707

Last Updated: 2025-01-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-17
• Study Completion Date: 2025-12-30

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.

Conditions

Postoperative; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Study group

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

Group Type: EXPERIMENTAL

Erector Spinae (ESP) Block with Lidocaine/Bupivacaine

Intervention Type: DRUG

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

Placebo Group

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

Group Type: PLACEBO_COMPARATOR

Erector Spinae (ESP) Block with placebo

Intervention Type: DRUG

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

Interventions

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)

Intervention Type: DRUG

Erector Spinae (ESP) Block with placebo

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

Intervention Type: DRUG

Other Intervention Names

Study group; Placebo group

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Dinsmore, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

Toronto Western Hospital?UHN

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Michael Dinsmore, MD

Role: CONTACT

michael.dinsmore@uhn.ca

416 603 5800 ext. 2269

Ki Jinn Chin, MD

Role: CONTACT

416 603 5800 ext. 2269

Facility Contacts

Michael Dinsmore, MD

Role: primary

Emad Al Azazi, MD

Role: backup

emad.alazazi@uhnresearch.ca

416-603-5800 ext. 6237

Other Identifiers

19-5818

Identifier Type: -

Identifier Source: org_study_id