Evaluation Of Three Different Anagesic Techniques In Patients Undergoing Lumbar Fixation Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Erector Spinae Plane Block, infiltration.
- Who it may be relevant to
- Registry conditions: Lumbar Fixation Surgery. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Other 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. - Other infiltration
Before the surgical team closes the incision, local infiltration with 40 mL of 0.25% bupivacaine will be performed at the surgical site.
Primary outcome measures
- Comparison of the Postoperative Efficacy of Analgesic Methods Using Salivary Opiorphin Levels [Time frame: postoperative 24 hours]
Secondary outcome measures (3)
- Total amount of opioid consumption [Time frame: Postoperative 24 hours]
- Pain scores in first 24 hours at rest and at movement [Time frame: postoperative 24 hours]
- Correlation between basal Salivary Opiorphin Levels and total 24 hours opioid consumption and pain scores [Time frame: postoperative 24 hours]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Ataturk University — Erzurum
Publications
- 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. PMID 38765858
- 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. PMID 36912781
- Lurie J, Tomkins-Lane C. Management of lumbar spinal stenosis. BMJ. 2016 Jan 4;352:h6234. doi: 10.1136/bmj.h6234. PMID 26727925
Identifiers
NCT: NCT06801574 · B.30.2.YYU.0.01.00.00/90