Spine DiseaseNCT07607509
Lumbar Paravertebral Block vs Erector Spinae Plane Block in Elderly Patients Undergoing Lumbar Spine Surgery
A study testing Ropivacaine 0.2% Injectable Solution in people with Spine Disease, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Spine Disease
- What is being tested?
- Ropivacaine 0.2% Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePoland
- Study dates
- 25 May 2026to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Grzegorz Kowalski, MD PhD contact
Poland1 site, 1 recruiting
- Recruiting
Poznan University of Medical Sciences
Poznan, 62-701
Malgorzata Reysner, M.D. Ph.D., +48 61 873 83 03, mreysner@ump.edu.pl
About this study
Official title: 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
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.
Read the 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 1:1:1 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.
- Conditions
- Spine Disease
- Being tested
- Ropivacaine 0.2% Injectable Solution
- Medical subject headings
- Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine 0.2% Injectable SolutionDrug
Also called Lumbar Erector Spinae Plane Block (L-ESPB)
Ultrasound-guided bilateral interfascial plane block performed at the lumbar level for postoperative analgesia in patients undergoing lumbar spine surgery.
Ropivacaine 0.2% Injectable SolutionDrug
Also called Lumbar Paravertebral Block (L-PVB)
Ultrasound-guided bilateral paravertebral block at the lumbar level targeting spinal nerves for postoperative analgesia in patients undergoing lumbar spine surgery.
| Study group | Role | What they receive |
|---|---|---|
| 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 7.5 mL per side (total 15 mL). All patients will receive standardized multimodal postoperative analgesia. Receives: Drug: Ropivacaine 0.2% Injectable Solution |
| 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 7.5 mL per side (total 15 mL). All patients will receive standardized multimodal postoperative analgesia. Receives: Drug: Ropivacaine 0.2% Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total opioid consumption within 48 hours after surgery
Total cumulative opioid consumption within the first 48 hours after surgery, converted to intravenous morphine equivalents.
Measured: 48 hours postoperatively
Secondary outcomes (22)
Time to first rescue analgesia
Time from completion of the surgery to the administration of the first dose of rescue opioid analgesic (in minutes).
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 48 hours postoperatively
Interleukin-6 (IL-6) level
serum interleukin-6 (IL-6) level
Measured: 12 hours after surgery
Interleukin-6 (IL-6) level
serum interleukin-6 (IL-6) level
Measured: 24 hours after surgery
Interleukin-6 (IL-6) level
serum interleukin-6 (IL-6) level
Measured: 48 hours after surgery
NLR
neutrophil-to-lymphocyte ratio (NLR)
Measured: 12 hours after surgery
NLR
neutrophil-to-lymphocyte ratio (NLR)
Measured: 24 hours after surgery
NLR
neutrophil-to-lymphocyte ratio (NLR)
Measured: 48 hours after surgery
PLR
platelet-to-lymphocyte ratio (PLR)
Measured: 12 hours after surgery
PLR
platelet-to-lymphocyte ratio (PLR)
Measured: 24 hours after surgery
PLR
platelet-to-lymphocyte ratio (PLR)
Measured: 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start25 May 2026
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katarzyna Wieczorowska-Tobis, MD PhD, Study chair, Poznan University of Medical SciencesMałgorzata Reysner, Md PhD, Study director, Poznan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07607509
- Sponsor's protocol ID
- 4/2026
- Status last verified
- Nov 2026
- First submitted
- 6 May 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07607509
- Acronym / sponsor ID
- 4/2026
- Conditions
- Spine Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 25 May 2026 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 1:1:1 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: Ropivacaine 0.2% Injectable SolutionParticipants 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. |
| General Anesthesia + Lumbar Paravertebral Block (L-PVB) | Active comparator | Drug: Ropivacaine 0.2% Injectable SolutionParticipants 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. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- Refusal to participate
- Chronic opioid therapy
- Coagulation disorders
- Use of anticoagulant therapy contraindicating regional anesthesia
- Infection at the planned needle insertion site
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ropivacaine 0.2% Injectable SolutionAlso: Lumbar Erector Spinae Plane Block (L-ESPB)Ultrasound-guided bilateral interfascial plane block performed at the lumbar level for postoperative analgesia in patients undergoing lumbar spine surgery. | Drug | General Anesthesia + Lumbar Erector Spinae Plane Block (L-ESPB) |
| Ropivacaine 0.2% Injectable SolutionAlso: Lumbar Paravertebral Block (L-PVB)Ultrasound-guided bilateral paravertebral block at the lumbar level targeting spinal nerves for postoperative analgesia in patients undergoing lumbar spine surgery. | Drug | General Anesthesia + Lumbar Paravertebral Block (L-PVB) |
Primary outcome
Total opioid consumption within 48 hours after surgery
Time frame: 48 hours postoperatively
Total cumulative opioid consumption within the first 48 hours after surgery, converted to intravenous morphine equivalents.
22 secondary outcomes
Time to first rescue analgesia
Time frame: 48 hours after surgery
Postoperative pain intensity at rest (NRS)
Time frame: 0 hours postoperatively
Postoperative pain intensity at rest (NRS)
Time frame: 2 hours postoperatively
Postoperative pain intensity at rest (NRS)
Time frame: 6 hours postoperatively
Postoperative pain intensity at rest (NRS)
Time frame: 12 hours postoperatively
Postoperative pain intensity at rest (NRS)
Time frame: 24 hours postoperatively
Postoperative pain intensity at rest (NRS)
Time frame: 48 hours postoperatively
Postoperative pain intensity at during movement (NRS)
Time frame: 0 hours postoperatively
Postoperative pain intensity at during movement (NRS)
Time frame: 2 hours postoperatively
Postoperative pain intensity at during movement (NRS)
Time frame: 6 hours postoperatively
Postoperative pain intensity at during movement (NRS)
Time frame: 12 hours postoperatively
Postoperative pain intensity at during movement (NRS)
Time frame: 24 hours postoperatively
Postoperative pain intensity at during movement (NRS)
Time frame: 48 hours postoperatively
Interleukin-6 (IL-6) level
Time frame: 12 hours after surgery
Interleukin-6 (IL-6) level
Time frame: 24 hours after surgery
Interleukin-6 (IL-6) level
Time frame: 48 hours after surgery
NLR
Time frame: 12 hours after surgery
NLR
Time frame: 24 hours after surgery
NLR
Time frame: 48 hours after surgery
PLR
Time frame: 12 hours after surgery
PLR
Time frame: 24 hours after surgery
PLR
Time frame: 48 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Grzegorz Kowalski, MD PhD contact
Katarzyna Wieczorowska-Tobis, MD PhD study chair
Poznan University of Medical Sciences
Małgorzata Reysner, Md PhD study director
Poznan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine 0.2% Injectable Solution in people with Spine Disease, run by Poznan University of Medical Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tomasz Reysner, MD PhD (+48 (61) 831-01-22, treysner@ump.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total opioid consumption within 48 hours after surgery (time frame: 48 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.