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This prospective, randomized controlled trial aims to compare the analgesic efficacy of lumbar paravertebral block (L-PVB) and lumbar erector spinae plane block (L-ESPB) in elderly patients undergoing lumbar spine surgery. Effective postoperative pain management in this population is essential due to increased susceptibility to opioid-related adverse effects.
Participants aged 65 years and older will be randomly assigned to receive either bilateral L-PVB or bilateral L-ESPB in addition to standardized general anesthesia. The primary objective is to evaluate differences in postoperative opioid consumption within the first 48 hours after surgery. Secondary outcomes include pain intensity, intraoperative opioid use, time to mobilization, length of hospital stay, and incidence of opioid-related adverse events.
Lumbar spine surgery is associated with significant postoperative pain, particularly in elderly patients, who are at increased risk of opioid-related adverse effects such as respiratory depression, sedation, delirium, and delayed mobilization. Regional anesthesia techniques may improve postoperative analgesia and reduce opioid requirements in this population.
The lumbar paravertebral block (L-PVB) is a well-established technique providing segmental analgesia by targeting spinal nerves in the paravertebral space. The erector spinae plane block (L-ESPB), a newer interfascial plane block, has gained popularity due to its technical simplicity and favorable safety profile. However, comparative data on their effectiveness in lumbar spine surgery, especially in elderly patients, remain limited.
This study is designed as a prospective, randomized, controlled trial comparing L-PVB and L-ESPB in patients aged 65 years and older undergoing elective lumbar spine surgery under general anesthesia. Participants will be randomly allocated in a 1:1 ratio to receive either bilateral L-PVB or bilateral L-ESPB with a standardized dose of local anesthetic.
All patients will receive a standardized general anesthesia protocol and multimodal analgesia regimen. Postoperative pain management will follow a uniform protocol across both groups.
The primary endpoint is total opioid consumption within 48 hours after surgery, expressed as intravenous morphine equivalents. Secondary endpoints include intraoperative opioid consumption, postoperative pain scores at predefined time points, time to first mobilization, length of hospital stay, use of rescue analgesia, and incidence of opioid-related adverse effects. Exploratory analyses will include assessment of inflammatory markers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General Anesthesia Alone (GA-only) | No Intervention | Participants will receive standardized general anesthesia and multimodal postoperative analgesia according to institutional protocol. No regional anesthesia technique will be performed. | |
| General Anesthesia + Lumbar Erector Spinae Plane Block (L-ESPB) | Active Comparator | Participants will receive standardized general anesthesia combined with bilateral lumbar erector spinae plane block (L-ESPB) performed under ultrasound guidance. Ropivacaine 0.2% will be administered at a volume of 20 mL per side (total 40 mL). No adjuvants will be used. All patients will receive standardized multimodal postoperative analgesia. |
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| General Anesthesia + Lumbar Paravertebral Block (L-PVB) | Active Comparator | Participants will receive standardized general anesthesia combined with bilateral lumbar paravertebral block (L-PVB) performed under ultrasound guidance. Ropivacaine 0.2% will be administered at a volume of 20 mL per side (total 40 mL). No adjuvants will be used. All patients will receive standardized multimodal postoperative analgesia. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine 0.2% Injectable Solution | Drug | Ultrasound-guided bilateral interfascial plane block performed at the lumbar level for postoperative analgesia in patients undergoing lumbar spine surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Total opioid consumption within 48 hours after surgery | Total cumulative opioid consumption within the first 48 hours after surgery, converted to intravenous morphine equivalents. | 48 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first rescue analgesia | Time from completion of the surgery to the administration of the first dose of rescue opioid analgesic (in minutes). | 48 hours after surgery |
| Postoperative pain intensity at rest (NRS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tomasz Reysner, MD PhD | Contact | +48 (61) 831-01-22 | treysner@ump.edu.pl | |
| Grzegorz Kowalski, MD PhD | Contact | gkowalski@ump.edu.pl |
| Name | Affiliation | Role |
|---|---|---|
| Katarzyna Wieczorowska-Tobis, MD PhD | Poznan University of Medical Sciences | Study Chair |
| Małgorzata Reysner, Md PhD | Poznan University of Medical Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Poznan University of Medical Sciences | Poznan | 62-701 | Poland |
Individual participant data (IPD) underlying the results reported in this study, after de-identification, will be made available to researchers upon reasonable request. The shared data will include demographic data, intervention allocation, and outcome measures.
Data will be available beginning 6 months after publication of the primary results and will remain available for up to 5 years.
Access to the data will be provided to researchers who submit a methodologically sound proposal. Requests will be reviewed by the principal investigator. Data will be shared after approval of a data access agreement.
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| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Ropivacaine 0.2% Injectable Solution | Drug | Ultrasound-guided bilateral paravertebral block at the lumbar level targeting spinal nerves for postoperative analgesia in patients undergoing lumbar spine surgery. |
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Pain intensity at rest assessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain)
| 0 hours postoperatively |
| Postoperative pain intensity at rest (NRS) | Pain intensity at rest assessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain) | 2 hours postoperatively |
| Postoperative pain intensity at rest (NRS) | Pain intensity at rest assessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain) | 6 hours postoperatively |
| Postoperative pain intensity at rest (NRS) | Pain intensity at rest assessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain) | 12 hours postoperatively |
| Postoperative pain intensity at rest (NRS) | Pain intensity at rest assessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain) | 24 hours postoperatively |
| Postoperative pain intensity at rest (NRS) | Pain intensity at rest assessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain) | 48 hours postoperatively |
| Postoperative pain intensity at during movement (NRS) | Pain intensity at during movementassessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain) | 0 hours postoperatively |
| Postoperative pain intensity at during movement (NRS) | Pain intensity at during movementassessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain) | 2 hours postoperatively |
| Postoperative pain intensity at during movement (NRS) | Pain intensity at during movementassessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain) | 6 hours postoperatively |
| Postoperative pain intensity at during movement (NRS) | Pain intensity at during movementassessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain) | 12 hours postoperatively |
| Postoperative pain intensity at during movement (NRS) | Pain intensity at during movementassessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain) | 24 hours postoperatively |
| Postoperative pain intensity at during movement (NRS) | Pain intensity at during movementassessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain) | 48 hours postoperatively |
| Interleukin-6 (IL-6) level | serum interleukin-6 (IL-6) level | 12 hours after surgery |
| Interleukin-6 (IL-6) level | serum interleukin-6 (IL-6) level | 24 hours after surgery |
| Interleukin-6 (IL-6) level | serum interleukin-6 (IL-6) level | 48 hours after surgery |
| NLR | neutrophil-to-lymphocyte ratio (NLR) | 12 hours after surgery |
| NLR | neutrophil-to-lymphocyte ratio (NLR) | 24 hours after surgery |
| NLR | neutrophil-to-lymphocyte ratio (NLR) | 48 hours after surgery |
| PLR | platelet-to-lymphocyte ratio (PLR) | 12 hours after surgery |
| PLR | platelet-to-lymphocyte ratio (PLR) | 24 hours after surgery |
| PLR | platelet-to-lymphocyte ratio (PLR) | 48 hours after surgery |
| D000588 |
| Amines |