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

NCT04646707 | Recruiting

• 1 other identifier: 19-5818
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative; Pain

Keywords

Opioid; Reduction; Enhanced; Postoperative; Recovery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Postoperative pain

  2 weeks and one month

• Opioids consumption

  2 weeks and one month

Study Arms (2)

Study group

EXPERIMENTAL

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

Placebo Group

PLACEBO COMPARATOR

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

Drug: Erector Spinae (ESP) Block with placebo

Interventions

Erector Spinae (ESP) Block with Lidocaine/Bupivacaine DRUG

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

Also known as: Study group

Study group

Erector Spinae (ESP) Block with placebo DRUG

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

Also known as: Placebo group

Placebo Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital?UHN

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Parapsychology; Dental Occlusion; Lidocaine; Bupivacaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavioral Sciences; Behavioral Disciplines and Activities; Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Michael Dinsmore, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Dinsmore, MD

CONTACT

416 603 5800; michael.dinsmore@uhn.ca

Ki Jinn Chin, MD

CONTACT

416 603 5800

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a double blind, randomized control clinical trial.

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: November 30, 2020
• Study Start: February 17, 2020
• Primary Completion: December 17, 2025
• Study Completion: December 30, 2025
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)