Erector Spinae Plane Block, Spinal Fusion, Spinal Stenosis, Spine Disease
Conditions
Brief summary
Effect of perineurial dexamethasone and dexmedetomidine on erector spinal plane block duration for spine surgery.
Detailed description
This study is proposed to explore the effect of perineurial Dexamethasone and Dexmedetomidine on erector spinal plane block duration for spine surgery. After spine surgery, patients need good analgesia. Peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe. The safety of local anaesthesia is essential due to the much lower toxicity threshold of local anaesthetics. An effective adjuvant, such as Dexamethasone or Dexmedetomidine, could allow for a higher dilution of local anaesthetics while maintaining and enhancing their analgesic effect. There is considerable research where intravenous and perineural dexamethasone and Dexmedetomidine use have been compared in adults. However, there is a massive lack of research regarding spine surgery and the Erector Spinae Plane Block. In this study, investigators compare perineural Dexamethasone and Dexmedetomidine. The investigator aims to find a dexamethasone or dexmedetomidine that covers the need for good pain relief and fast recovery postoperatively.
Interventions
DRUG0.9% Sodium Chloride Injection
biliteral administration of 20ml of 0,2% ropivacaine + 2ml 0.9% sodium chloride for the erector spine plane block
biliteral administration of 20ml of 0,2% ropivacaine with 4mg Dexamethasone for the erector spine plane block
DRUGDexmedetomidine injection
biliteral administration of 20ml of 0,2% ropivacaine with 50ug Dexmedetomidine for the erector spine plane block
Sponsors
Poznan University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* patients undergoing primary posterior lumbar decompression and stabilization with instrumentation involving multi-levels in the lumbar region, * aged \>18 years and \<100 years * ASA physical status 1, 2 or 3.
Exclusion criteria
* refuse to participate, * history of opioid abuse, * infection of the puncture site, * aged \<18 years and \>100 years * ASA 4 and 5
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| first need of opiate | 48 hours | Time after surgery when the patient needs opiate for the first time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid consumption | 48 hours | Total opiate consumption after surgery |
| Numerical Rating Scale [range 0:10] | Time Frame: 4 hours after surgery | NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever) |
| NLR | 48 hours after surgery | Neutrophil-to-lymphocyte ratio |
| PLR | 48 hours after surgery | Platelet-to-lymphocyte ratio |
Countries
Poland
Contacts
PRINCIPAL_INVESTIGATORMalgorzata Domagalska, PhD
Poznań University of Medical Sciences
Outcome results
None listed