Lumbar Fixation Surgery
Conditions
Keywords
lumbar fixation surgery, erector spinal plane block, local infiltration
Brief summary
Lumbar spinal stenosis is a degenerative condition characterized by the narrowing of the space surrounding the neurovascular structures of the lumbar vertebrae, resulting from age-related changes in the intervertebral discs, ligamentum flavum, and facet joints. It commonly causes unilateral pain in the lower back, hips, and legs, often described as cramping or burning. Postoperative pain management in these cases frequently involves oral opioids or intravenous administration using patient-controlled analgesia devices. However, opioids are associated with side effects such as reduced gastrointestinal motility, urinary retention, and respiratory depression. To mitigate these issues, local anesthetic wound infiltration is widely employed by surgeons to manage postoperative pain and reduce opioid consumption following lumbar spinal surgeries. The primary aim of this study is to compare the postoperative efficacy of three different analgesic methods in patients undergoing elective lumbar fixation surgery, using the percentage change in salivary opiorphin levels as a marker. Additionally, the study seeks to evaluate the correlation between these changes and postoperative pain scores, as well as the amount of opioids consumed.
Interventions
OTHERErector Spinae Plane Block
After the surgical team places the final suture, while the patient is in the prone position, an ultrasound-guided ESP (Erector Spinae Plane) block will be administered bilaterally using a block needle. A total of 40 mL of 0.25% bupivacaine will be injected.
OTHERinfiltration
Before the surgical team closes the incision, local infiltration with 40 mL of 0.25% bupivacaine will be performed at the surgical site.
Sponsors
Ataturk University
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 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients scheduled to undergo lumbar fixation surgery under general anesthesia * aged between 18 and 65 years, * American Society of Anesthesiologists physical status classification of I-II
Exclusion criteria
* Patients with a known allergy to local anesthetics. * Patients who used opioid analgesics within 48 hours prior to sample collection. * Patients with a history of smoking or alcohol consumption. * Patients with conditions affecting salivary flow, such as xerostomia or those who have undergone radiotherapy. * Patients with infectious diseases known to be transmissible through saliva. * Patients with an ASA physical status classification of III or higher. * Patients unable to use a patient-controlled analgesia (PCA) device. * Patients who do not consent to the study procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the Postoperative Efficacy of Analgesic Methods Using Salivary Opiorphin Levels | postoperative 24 hours | The primary aim of this study is to compare the postoperative efficacy of three different analgesic methods applied to patients undergoing elective lumbar fixation surgery by assessing the percentage change in salivary opiorphin levels. Additionally, the study aims to evaluate the correlation of these changes with postoperative Visual Analog Scale (VAS) pain scores and the amount of opioids consumed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total amount of opioid consumption | Postoperative 24 hours | the secondary objective was to measure the total amount of opioid consumption in the first 24 hours postoperatively |
| Pain scores in first 24 hours at rest and at movement | postoperative 24 hours | Evaluation of pain scores during movement and rest within 24 hours postoperatively using the Visual Analog Scale |
| Correlation between basal Salivary Opiorphin Levels and total 24 hours opioid consumption and pain scores | postoperative 24 hours | The correlation between basal salivary opiorphin levels and total 24-hour opioid consumption, as well as pain scores will be analyzed to reveal any correlation |
Countries
Turkey (Türkiye)
Contacts
Primary ContactFeyza Simsek
Backup ContactCanan Atalay
Outcome results
None listed