Poznan University of Medical Sciences
Poznan, 62-701, Poland
Location status: Recruiting
NCT Number: NCT07180940
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
Poznan, 62-701, Poland
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
2 x 20ml 0.2% ropivacaine with 2ml of 0.9% NaCl
2 x 20ml 0.2% ropivacaine with 2mg of dexamethasone
2 x 20ml 0.2% ropivacaine with 25ug Dexmedetomidine
Time frame: 48 hours after surgery
Cumulative opioid consumption during the first 24 and 48 hours after surgery, converted to morphine milligram equivalents (MME)
Time frame: 4 hours after surgery
Numerical Rating Scale (0 - no pain; 10 - the worst pain ever)
Time frame: 8 hours after surgery
Numerical Rating Scale (0 - no pain; 10 - the worst pain ever)
Time frame: 12 hours after surgery
Numerical Rating Scale (0 - no pain; 10 - the worst pain ever)
Time frame: 24 hours after surgery
Numerical Rating Scale (0 - no pain; 10 - the worst pain ever)
Time frame: 48 hours after surgery
Numerical Rating Scale (0 - no pain; 10 - the worst pain ever)
Time frame: 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)
Time frame: 24 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)
Time frame: 48 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)
Time frame: 48 hours after surgery
nausea, vomitting, bradycardia, hypotension
Time frame: 48 hours after surgery
Time after surgery when the patient needs rescue analgesia for the first time
Time frame: 12 hours after surgery
Blood glucose concentration measured postoperatively
Time frame: 24 hours after surgery
Blood glucose concentration measured postoperatively
Time frame: 48 hours after surgery
Blood glucose concentration measured postoperatively
Time frame: 12 hours after surgery
NLR will be calculated from complete blood count results
Time frame: 24 hours after surgery
NLR will be calculated from complete blood count results
Time frame: 48 hours after surgery
NLR will be calculated from complete blood count results
Time frame: 12 hours after surgery
PLR will be calculated from complete blood count results
Time frame: 24 hours after surgery
PLR will be calculated from complete blood count results
Time frame: 48 hours after surgery
PLR will be calculated from complete blood count results
Contact information is provided by the study sponsor or research team.
Poznan University of Medical Sciences
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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