Clinical trial NCT04646707: Effect of Erector Spinae (ESP) Block on Opioid Reduction and Enhanced Recovery After Posterior Cervical Spine Surgery
Official title: Effect of Erector Spinae (ESP) Block on Opioid Reduction and Enhanced Recovery After Posterior Cervical Spine Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative
Pain
Keywords: Opioid
Reduction
Enhanced
Postoperative
Recovery
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2020-11-30
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a double blind, randomized control clinical trial.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Quality of Recovery 40 Questionnaire
timeFrame: 24 hours after surgery.
Secondary outcomes:
measure: Postoperative pain
timeFrame: 2 weeks and one month
measure: Opioids consumption
timeFrame: 2 weeks and one month
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital?UHN
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Michael Dinsmore, MD
role: PRINCIPAL_INVESTIGATOR
References: