Ataturk University
Erzurum, Turkey (Türkiye)
Location status: Recruiting
Location contact
Canan Atalay
CONTACT
Recruiting
NCT Number: NCT06801574
Evaluation Of Three Different Anagesic Techniques In Patients Undergoing Lumbar Fixation Surgery
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Erector spinae plane block
OtherAfter 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.
Infiltration
OtherBefore the surgical team closes the incision, local infiltration with 40 mL of 0.25% bupivacaine will be performed at the surgical site.
Primary outcomes
-
Comparison of the Postoperative Efficacy of Analgesic Methods Using Salivary Opiorphin Levels
Time frame: 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 outcomes
-
Total amount of opioid consumption
Time frame: 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
Time frame: 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
Time frame: 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
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Ataturk University
Other
Registry information
Official study title
EVALUATION OF POSTOPERATIVE EFFECT OF THREE DIFFERENT ANALGESIC TECHNIQUES IN PATIENTS UNDERGOING LUMBAR FIXATION SURGERY USING SALIVARY OPIORPHIN LEVEL: A PROSPECTIVE RANDOMIZED CLINICAL STUDY
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Jan 30, 2025
- Registry last updated
- Oct 3, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Completed
Effect of Addition of Dexmedetomidine During Ultrasound Guided Bilateral Single Shot Erector Spinae Plane Block in Patients Undergoing Posterior Lumbar Interbody Fusion Under General Anesthesia
NCT03746418
Bone Diseases, Double Level Lumbar Spondylolisthesis (L3-L5)
Tanta, Egypt
View Trial Details