Poznan University of Medical Sciences
Poznan, 62-701, Poland
NCT Number: NCT07607509
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.
Trial opening soon.
Get Notified65 year–100 year
All sexes
Interventional
Not applicable
Poznan, 62-701, Poland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ultrasound-guided bilateral interfascial plane block performed at the lumbar level for postoperative analgesia in patients undergoing lumbar spine surgery.
Other names: Lumbar Erector Spinae Plane Block (L-ESPB)
Time frame: 48 hours postoperatively
Total cumulative opioid consumption within the first 48 hours after surgery, converted to intravenous morphine equivalents.
Time frame: 48 hours after surgery
Time from completion of the surgery to the administration of the first dose of rescue opioid analgesic (in minutes).
Time frame: 0 hours postoperatively
Pain intensity at rest assessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain)
Time frame: 2 hours postoperatively
Pain intensity at rest assessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain)
Time frame: 6 hours postoperatively
Pain intensity at rest assessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain)
Time frame: 12 hours postoperatively
Pain intensity at rest assessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain)
Time frame: 24 hours postoperatively
Pain intensity at rest assessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain)
Time frame: 48 hours postoperatively
Pain intensity at rest assessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain)
Time frame: 0 hours postoperatively
Pain intensity at during movementassessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain)
Time frame: 2 hours postoperatively
Pain intensity at during movementassessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain)
Time frame: 6 hours postoperatively
Pain intensity at during movementassessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain)
Time frame: 12 hours postoperatively
Pain intensity at during movementassessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain)
Time frame: 24 hours postoperatively
Pain intensity at during movementassessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain)
Time frame: 48 hours postoperatively
Pain intensity at during movementassessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain)
Time frame: 12 hours after surgery
serum interleukin-6 (IL-6) level
Time frame: 24 hours after surgery
serum interleukin-6 (IL-6) level
Time frame: 48 hours after surgery
serum interleukin-6 (IL-6) level
Time frame: 12 hours after surgery
neutrophil-to-lymphocyte ratio (NLR)
Time frame: 24 hours after surgery
neutrophil-to-lymphocyte ratio (NLR)
Time frame: 48 hours after surgery
neutrophil-to-lymphocyte ratio (NLR)
Time frame: 12 hours after surgery
platelet-to-lymphocyte ratio (PLR)
Time frame: 24 hours after surgery
platelet-to-lymphocyte ratio (PLR)
Time frame: 48 hours after surgery
platelet-to-lymphocyte ratio (PLR)
Contact information is provided by the study sponsor or research team.
Grzegorz Kowalski, MD PhD
CONTACT
Tomasz Reysner, MD PhD
CONTACT
Poznan University of Medical Sciences
Other
A Prospective, Randomized Controlled Trial Comparing the Analgesic Efficacy of Lumbar Paravertebral Block and Lumbar Erector Spinae Plane Block in Elderly Patients Undergoing Lumbar Spine Surgery
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06974721
Bone Diseases, Musculoskeletal Diseases
View Trial DetailsNCT06462729
Bone Diseases, Degenerative Disc Disease
Fort Wayne, Indiana, United States
View Trial DetailsNCT06233617
Bone Diseases, Erector Spinae Plane Block
Poznan, Poznań, Poland
View Trial DetailsNCT06400680
Bone Diseases, Gait
Bosisio Parini, Lecco, Italy
View Trial Details