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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Erector Spinae Plane Block | Active Comparator |
| |
| Group Local Infiltration | Active Comparator |
| |
| Group Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erector Spinae Plane Block | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the Postoperative Efficacy of Analgesic Methods Using Salivary Opiorphin Levels | 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. | postoperative 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Total amount of opioid consumption | the secondary objective was to measure the total amount of opioid consumption in the first 24 hours postoperatively | Postoperative 24 hours |
| Pain scores in first 24 hours at rest and at movement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feyza Simsek | Contact | +90 554 947 52 61 | feyzasimsek0205@gmail.com | |
| Canan Atalay | Contact | +90 (533) 363 53 18 |
| Name | Affiliation | Role |
|---|---|---|
| Feyza Simsek | Dr | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ataturk University | Recruiting | Erzurum | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38765858 | Result | 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. | |
| 36912781 | Result | 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. |
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|
| infiltration | Other | Before the surgical team closes the incision, local infiltration with 40 mL of 0.25% bupivacaine will be performed at the surgical site. |
|
Evaluation of pain scores during movement and rest within 24 hours postoperatively using the Visual Analog Scale
| postoperative 24 hours |
| Correlation between basal Salivary Opiorphin Levels and total 24 hours opioid consumption and pain scores | The correlation between basal salivary opiorphin levels and total 24-hour opioid consumption, as well as pain scores will be analyzed to reveal any correlation | postoperative 24 hours |
| 26727925 | Result | Lurie J, Tomkins-Lane C. Management of lumbar spinal stenosis. BMJ. 2016 Jan 4;352:h6234. doi: 10.1136/bmj.h6234. |