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

Sponsor

University Health Network, Toronto (Other)

Overall Status

Recruiting

CT.gov ID

NCT04646707

Collaborator

(none)

Enrollment

Location

Arms

25.4

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Drug: Erector Spinae (ESP) Block with Lidocaine/Bupivacaine Drug: Erector Spinae (ESP) Block with placebo	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This is a double blind, randomized control clinical trial.This is a double blind, randomized control clinical trial.

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 17, 2020

Anticipated Primary Completion Date :

Feb 17, 2022

Anticipated Study Completion Date :

Mar 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study group 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 Bilateral ESP block at T1 level with 20 ml of 1:1 mixture (2% Lidocaine: 0.5% bupivacaine) Other Names: Study group
Placebo Comparator: Placebo Group Bilateral ESP block at T1 level with 20 ml of 0.9% normal saline	Drug: Erector Spinae (ESP) Block with placebo Bilateral ESP block at T1 level with 20 ml of 0.9% normal saline Other Names: Placebo group

Arm

Intervention/Treatment

Experimental: Study group

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

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

Other Names:

Study group

Placebo Comparator: Placebo Group

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

Drug: Erector Spinae (ESP) Block with placebo

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

Other Names:

Placebo group

Outcome Measures

Primary Outcome Measures

Quality of Recovery 40 Questionnaire [24 hours after surgery.]
the global Quality of Recovery-40 aggregate score is a scale from (1 to 5, where: 1 = very poor and 5 = excellent)

Secondary Outcome Measures

Postoperative pain [2 weeks and one month]
is a visual analog scale from (1 to 10, where: 1 is the mildest and 10 the worst possible)
Opioids consumption [2 weeks and one month]
Patient Opioid/Non-Opioid Pain Medications Diary Card After Surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.