Clinical trial NCT06801574: Evaluation of Three Different Anagesic Techniques in Patients Undergoing Lumbar Fixation Surgery
Official 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lumbar Fixation Surgery
Keywords: lumbar fixation surgery
erector spinal plane block
local infiltration
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2025-01-30
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Comparison of the Postoperative Efficacy of Analgesic Methods Using Salivary Opiorphin Levels
timeFrame: postoperative 24 hours
Secondary outcomes:
measure: Total amount of opioid consumption
timeFrame: Postoperative 24 hours
measure: Pain scores in first 24 hours at rest and at movement
timeFrame: postoperative 24 hours
measure: Correlation between basal Salivary Opiorphin Levels and total 24 hours opioid consumption and pain scores
timeFrame: postoperative 24 hours
Other outcomes:
Locations:
Study officials:
References:
citation: Deng K, Huang K, Wu GF. Ultrasound-guided erector spinae plane block in posterior lumbar surgery (Review). Biomed Rep. 2024 Apr 22;20(6):95. doi: 10.3892/br.2024.1783. eCollection 2024 Jun.
citation: Hong B, Baek S, Kang H, Oh C, Jo Y, Lee S, Park S. Regional analgesia techniques for lumbar spine surgery: a frequentist network meta-analysis. Int J Surg. 2023 Jun 1;109(6):1728-1741. doi: 10.1097/JS9.0000000000000270.
citation: Lurie J, Tomkins-Lane C. Management of lumbar spinal stenosis. BMJ. 2016 Jan 4;352:h6234. doi: 10.1136/bmj.h6234.