Spine Disease
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGRopivacaine 0.2% Injectable Solution
Ultrasound-guided bilateral interfascial plane block performed at the lumbar level for postoperative analgesia in patients undergoing lumbar spine surgery.
Sponsors
Poznan University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* ge ≥65 years * Scheduled for elective lumbar spine surgery * American Society of Anesthesiologists (ASA) physical status I-III * Ability to assess pain using the Numeric Rating Scale (NRS) * Provision of written informed consent
Exclusion criteria
* Refusal to participate * Chronic opioid therapy * Coagulation disorders * Use of anticoagulant therapy contraindicating regional anesthesia * Infection at the planned needle insertion site * Allergy to ropivacaine or other study-related medications * Severe hepatic failure * Severe renal failure * Cognitive impairment preventing reliable pain assessment * Inability to cooperate with study procedures * Extensive reoperation or surgery of unusually large extent that may interfere with outcome assessment * Contraindications to general anesthesia or regional anesthesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total opioid consumption within 48 hours after surgery | 48 hours postoperatively | Total cumulative opioid consumption within the first 48 hours after surgery, converted to intravenous morphine equivalents. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to first rescue analgesia | 48 hours after surgery | Time from completion of the surgery to the administration of the first dose of rescue opioid analgesic (in minutes). |
| Postoperative pain intensity at rest (NRS) | 0 hours postoperatively | Pain intensity at rest assessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain) |
| Postoperative pain intensity at during movement (NRS) | 0 hours postoperatively | Pain intensity at during movementassessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain) |
| Interleukin-6 (IL-6) level | 12 hours after surgery | serum interleukin-6 (IL-6) level |
| NLR | 12 hours after surgery | neutrophil-to-lymphocyte ratio (NLR) |
| PLR | 12 hours after surgery | platelet-to-lymphocyte ratio (PLR) |
Countries
Poland
Contacts
CONTACTTomasz Reysner, MD PhD
CONTACTGrzegorz Kowalski, MD PhD
STUDY_CHAIRKatarzyna Wieczorowska-Tobis, MD PhD
Poznan University of Medical Sciences
STUDY_DIRECTORMałgorzata Reysner, Md PhD
Poznan University of Medical Sciences
Outcome results
None listed