Recruiting

ESP Block

Sponsor:

University Health Network, Toronto

Code:

NCT04646707

Conditions

Postoperative

Pain

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Erector Spinae (ESP) Block with Lidocaine/Bupivacaine

Erector Spinae (ESP) Block with placebo

Study Details

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

Study ID

NCT04646707

Start date

Feb 17, 2020

Status verified date

Jan, 2025

Completion date

Dec 30, 2025

Anticipated

Primary completion date

Dec 17, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

52 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Study group

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

placebo comparator: Placebo Group

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)

Erector Spinae (ESP) Block with placebo

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

Primary outcome measure

  • Quality of Recovery 40 Questionnaire [ Time Frame: 24 hours after surgery. ]

Central Contacts and Locations

Central contacts

Michael Dinsmore, MD

416 603 5800michael.dinsmore@uhn.ca

Ki Jinn Chin, MD

416 603 5800

Locations

Toronto Western Hospital?UHN

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Emad Al Azazi, MD

416-603-5800emad.alazazi@uhnresearch.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jan 30, 2025

Last verified

Jan, 2025

Keywords

  • Opioid
  • Reduction
  • Enhanced
  • Postoperative
  • Recovery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2025-01-30.