Comparing three analgesic techniques for lumbar fixation surgery
EVALUATION OF POSTOPERATIVE EFFECT OF THREE DIFFERENT ANALGESIC TECHNIQUES IN PATIENTS UNDERGOING LUMBAR FIXATION SURGERY USING SALIVARY OPIORPHIN LEVEL: A PROSPECTIVE RANDOMIZED CLINICAL STUDY
This trial tests three ways of controlling pain — including an erector spinae plane block and wound infiltration — for adults having elective lumbar fixation surgery to see if they reduce postoperative pain and opioid use.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Ataturk University Academic / other |
| Locations | 1 site (Erzurum) |
| Trial ID | NCT06801574 on ClinicalTrials.gov |
What this trial studies
This interventional trial compares postoperative pain control provided by three different analgesic approaches in adults undergoing elective lumbar fixation under general anesthesia. Eligible participants aged 18–65 with ASA physical status I–II will receive one of the analgesic techniques perioperatively and then be followed after surgery. Postoperative pain scores and opioid consumption via patient-controlled analgesia will be recorded, along with standard safety monitoring. Patients with allergies to local anesthetics, recent opioid use, significant comorbidities, or inability to use PCA are excluded.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–65 scheduled for elective lumbar fixation under general anesthesia with ASA I–II status who can use a PCA device and have no contraindication to local anesthetics.
Not a fit: Patients with ASA III or higher, known allergy to local anesthetics, recent opioid use, smoking or alcohol history, or inability to use PCA are unlikely to benefit from participating.
Why it matters
Potential benefit: If one technique provides better pain relief with less opioid use, patients could experience lower pain levels and fewer opioid-related side effects after lumbar fixation.
How similar studies have performed: Prior small trials and case series have suggested erector spinae plane blocks and local wound infiltration can reduce postoperative pain and opioid use after spine surgeries, but large randomized comparisons are limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Erzurum
- Ataturk University — Erzurum, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Feyza Simsek — Dr
- Study coordinator: Feyza Simsek
- Email: feyzasimsek0205@gmail.com
- Phone: +90 554 947 52 61
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.