Pain, Postoperative
Conditions
Keywords
Opioid, Reduction, Enhanced, Postoperative, Recovery
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.
Interventions
Bilateral ESP block at T1 level with 20 ml of 1:1 mixture (2% Lidocaine: 0.5% bupivacaine)
DRUGErector Spinae (ESP) Block with placebo
Bilateral ESP block at T1 level with 20 ml of 0.9% normal saline
Sponsors
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
This is a double blind, randomized control clinical trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Canada
Contacts
Primary ContactMichael Dinsmore, MD
Backup ContactKi Jinn Chin, MD
Outcome results
None listed