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NCT Number: NCT07607509

Lumbar Paravertebral Block vs 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.

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Key information

Age range

65 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Poznan University of Medical Sciences

Poznan, 62-701, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Lumbar Erector Spinae Plane Block (L-ESPB)

Primary outcomes

  1. 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.

Secondary outcomes

  1. Time to first rescue analgesia

    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).

  2. Postoperative pain intensity at rest (NRS)

    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)

  3. Postoperative pain intensity at rest (NRS)

    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)

  4. Postoperative pain intensity at rest (NRS)

    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)

  5. Postoperative pain intensity at rest (NRS)

    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)

  6. Postoperative pain intensity at rest (NRS)

    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)

  7. Postoperative pain intensity at rest (NRS)

    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)

  8. Postoperative pain intensity at during movement (NRS)

    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)

  9. Postoperative pain intensity at during movement (NRS)

    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)

  10. Postoperative pain intensity at during movement (NRS)

    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)

  11. Postoperative pain intensity at during movement (NRS)

    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)

  12. Postoperative pain intensity at during movement (NRS)

    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)

  13. Postoperative pain intensity at during movement (NRS)

    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)

  14. Interleukin-6 (IL-6) level

    Time frame: 12 hours after surgery

    serum interleukin-6 (IL-6) level

  15. Interleukin-6 (IL-6) level

    Time frame: 24 hours after surgery

    serum interleukin-6 (IL-6) level

  16. Interleukin-6 (IL-6) level

    Time frame: 48 hours after surgery

    serum interleukin-6 (IL-6) level

  17. NLR

    Time frame: 12 hours after surgery

    neutrophil-to-lymphocyte ratio (NLR)

  18. NLR

    Time frame: 24 hours after surgery

    neutrophil-to-lymphocyte ratio (NLR)

  19. NLR

    Time frame: 48 hours after surgery

    neutrophil-to-lymphocyte ratio (NLR)

  20. PLR

    Time frame: 12 hours after surgery

    platelet-to-lymphocyte ratio (PLR)

  21. PLR

    Time frame: 24 hours after surgery

    platelet-to-lymphocyte ratio (PLR)

  22. PLR

    Time frame: 48 hours after surgery

    platelet-to-lymphocyte ratio (PLR)

Study contacts

Contact information is provided by the study sponsor or research team.

Grzegorz Kowalski, MD PhD

CONTACT

[email protected]

Tomasz Reysner, MD PhD

CONTACT

[email protected]

+48 (61) 831-01-22

Sponsors and collaborators

Lead sponsor

Poznan University of Medical Sciences

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 26, 2026
Registry last updated
May 26, 2026

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.

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