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Clinical Trials in Turkey / NCT06801574
Recruiting Not applicable

Evaluation Of Three Different Anagesic Techniques In Patients Undergoing Lumbar Fixation Surgery

NCT06801574 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2025-02-01
Last updated
2025-10-03

Condition(s) studied

Lumbar Fixation Surgery

Investigational drug(s) / intervention(s)

Erector Spinae Plane Blockinfiltration

Erector 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.

infiltration: Before the surgical team closes the incision, local infiltration with 40 mL of 0.25% bupivacaine will be performed at the surgical site.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Ataturk University Erzurum Turkey (Türkiye) Recruiting

More Ataturk University trials in Turkey

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06801574 on ClinicalTrials.gov ↗ ← All trials in Turkey