NCT06801574 Evaluation Of Three Different Anagesic Techniques In Patients Undergoing Lumbar Fixation Surgery
| NCT ID | NCT06801574 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ataturk University |
| Condition | Lumbar Fixation Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2025-02-01 |
| Primary Completion | 2026-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 84 participants in total. It began in 2025-02-01 with a primary completion date of 2026-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Feyza Simsek
PRINCIPAL INVESTIGATOR
Dr
Frequently Asked Questions
Who can join the NCT06801574 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Lumbar Fixation Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06801574 currently recruiting?
Yes, NCT06801574 is actively recruiting participants. Contact the research team at feyzasimsek0205@gmail.com for enrollment information.
Where is the NCT06801574 trial being conducted?
This trial is being conducted at Erzurum, Turkey (Türkiye).
Who is sponsoring the NCT06801574 clinical trial?
NCT06801574 is sponsored by Ataturk University. The principal investigator is Feyza Simsek at Dr. The trial plans to enroll 84 participants.