An interventional study of Ropivacaine 0.2% Injectable Solution and Ropivacaine 0.2% Injectable Solution in Spine Disease, sponsored by Poznan University of Medical Sciences. Recruiting at 1 site in Poland. Open to participants aged 65 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Poznan University of Medical Sciences · Not applicable, Interventional, and Treatment
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 1:1:1 ratio to receive either bilateral L-PVB or bilateral L-ESPB with a standardized dose of local anesthetic or general anesthesia only.
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.
174 studies on the registry are indexed under Spinal Diseases; 39 are open to participants now.
This study's planned enrollment of 120 is above the median of 60 across 106 interventional studies indexed under Spinal Diseases.
Browse Spinal Diseases studies →Poznan University of Medical Sciences is the lead sponsor of 151 studies on the registry; 41 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive standardized general anesthesia and multimodal postoperative analgesia according to institutional protocol. No regional anesthesia technique will be performed.
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 7.5 mL per side (total 15 mL). All patients will receive standardized multimodal postoperative analgesia.
Drug: Ropivacaine 0.2% Injectable Solution
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 7.5 mL per side (total 15 mL). All patients will receive standardized multimodal postoperative analgesia.
Drug: Ropivacaine 0.2% Injectable Solution
Ultrasound-guided bilateral interfascial plane block performed at the lumbar level for postoperative analgesia in patients undergoing lumbar spine surgery.
Also known as: Lumbar Erector Spinae Plane Block (L-ESPB)
Ultrasound-guided bilateral paravertebral block at the lumbar level targeting spinal nerves for postoperative analgesia in patients undergoing lumbar spine surgery.
Also known as: Lumbar Paravertebral Block (L-PVB)
Total opioid consumption within 48 hours after surgery
Total cumulative opioid consumption within the first 48 hours after surgery, converted to intravenous morphine equivalents.
Time frame: 48 hours postoperatively
Time to first rescue analgesia
Time from completion of the surgery to the administration of the first dose of rescue opioid analgesic (in minutes).
Time frame: 48 hours after surgery
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 48 hours postoperatively
Interleukin-6 (IL-6) level
serum interleukin-6 (IL-6) level
Time frame: 12 hours after surgery
Interleukin-6 (IL-6) level
serum interleukin-6 (IL-6) level
Time frame: 24 hours after surgery
Interleukin-6 (IL-6) level
serum interleukin-6 (IL-6) level
Time frame: 48 hours after surgery
NLR
neutrophil-to-lymphocyte ratio (NLR)
Time frame: 12 hours after surgery
NLR
neutrophil-to-lymphocyte ratio (NLR)
Time frame: 24 hours after surgery
NLR
neutrophil-to-lymphocyte ratio (NLR)
Time frame: 48 hours after surgery
PLR
platelet-to-lymphocyte ratio (PLR)
Time frame: 12 hours after surgery
PLR
platelet-to-lymphocyte ratio (PLR)
Time frame: 24 hours after surgery
PLR
platelet-to-lymphocyte ratio (PLR)
Time frame: 48 hours after surgery
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data will be available beginning 6 months after publication of the primary results and will remain available for up to 5 years.
Access criteria: 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.
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Jul 2027, 14 months after the start.
Of 40 non-industry interventional studies with no phase under Spinal Diseases, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 50. This study's planned 14 months is below that.
Counting every sponsor, half of 43 studies reached it within 26 months; a quarter within 16 and three quarters within 60.
Start moved once since we started tracking on Sep 25, 2026: Jun 2026 → May 2026, on Nov 5, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Ropivacaine
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