Spine Disease, Spinal Diseases
Conditions
Brief summary
This clinical study aims to determine which of two medications-dexamethasone or dexmedetomidine-works better and is safer when used together with a local anesthetic (ropivacaine) in a type of nerve block called the erector spinae plane block (ESPB). This block helps reduce pain after lumbar spine surgery.
Detailed description
All participants will receive general anesthesia for surgery and, in addition, a nerve block on both sides of the lower back. The nerve block will be done with ultrasound guidance and will include ropivacaine plus either dexamethasone or dexmedetomidine. Patients will be randomly assigned to one of these two groups, and neither the patient nor the doctors checking pain after surgery will know which medication was used. The main goal is to see how much opioid pain medicine patients need during the first 24 and 48 hours after surgery. Other things we will look at include how strong the pain is, how soon pain relief is necessary, if there are any side effects like nausea or low blood pressure, and if there are any complications related to the block. This study will help doctors choose the best option to manage pain after spine surgery while reducing the need for opioids and their side effects.
Interventions
DRUG0.9%NaCl
2 x 20ml 0.2% ropivacaine with 2ml of 0.9% NaCl
DRUGDexamethasone 4mg
2 x 20ml 0.2% ropivacaine with 2mg of dexamethasone
DRUGDexmedetomidine
2 x 20ml 0.2% ropivacaine with 25ug Dexmedetomidine
Sponsors
Poznan University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 to N/A (no limit) * Scheduled for elective lumbar spine surgery (e.g., decompression or fusion) via posterior approach * American Society of Anesthesiologists (ASA) physical status I-III * Body weight ≥ 50 kg * Ability to provide written informed consent * Expected postoperative hospitalization of at least 48 hours
Exclusion criteria
* Known allergy or contraindication to ropivacaine, dexamethasone, or dexmedetomidine * Infection at or near the site of block placement * Coagulation disorders or current use of anticoagulant therapy (not discontinued per guidelines) * Chronic opioid use or opioid dependence * Neurological or psychiatric disorders interfering with pain assessment * Diabetes mellitus with poorly controlled glycemia (e.g., HbA1c \> 8%) * Severe hepatic or renal dysfunction * Body mass index (BMI) \> 40 kg/m² * Pregnancy or breastfeeding * Refusal or inability to cooperate with the study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total opioid Consuption | 48 hours after surgery | Cumulative opioid consumption during the first 24 and 48 hours after surgery, converted to morphine milligram equivalents (MME) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nerve injury | 12 hours after surgery | Nerve damage assesment will be performed using the nerve damage score (N0- no nerve damage; N1- minor - sensory paresthesia; N2- major -complete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome) |
| adverce effects | 48 hours after surgery | nausea, vomitting, bradycardia, hypotension |
| Time to first rescue analgesia | 48 hours after surgery | Time after surgery when the patient needs rescue analgesia for the first time |
| NRS | 4 hours after surgery | Numerical Rating Scale (0 - no pain; 10 - the worst pain ever) |
| NLR - Neutrophil-to-Lymphocyte Ratio | 12 hours after surgery | NLR will be calculated from complete blood count results |
| PLR - Platelet-to-Lymphocyte Ratio | 12 hours after surgery | PLR will be calculated from complete blood count results |
| blood glucose | 12 hours after surgery | Blood glucose concentration measured postoperatively |
Countries
Poland
Contacts
Primary ContactMalgorzata Reysner, M.D. Ph.D.
Outcome results
None listed