EVALUATION OF POSTOPERATIVE EFFECT OF THREE DIFFERENT ANALGESIC TECHNIQUES IN PATIENTS UNDERGOING LUMBAR FIXATION SURGERY USING SALIVARY OPIORPHIN LEVEL: A PROSPECTIVE RANDOMIZED CLINICAL STUDY
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Ataturk University
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- Comparison of the Postoperative Efficacy of Analgesic Methods Using Salivary Opiorphin Levels
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Group Local Infiltration
Intervention: infiltration (Other)
Group Control
Group Erector Spinae Plane Block
Intervention: Erector Spinae Plane Block (Other)
Outcomes
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(Postoperative 24 hours)
- Pain scores in first 24 hours at rest and at movement(postoperative 24 hours)
- Correlation between basal Salivary Opiorphin Levels and total 24 hours opioid consumption and pain scores(postoperative 24 hours)
Investigators
Feyza Şimşek
Dr
Ataturk University