Lumbar Paravertebral Block vs Erector Spinae Plane Block in Elderly Patients Undergoing Lumbar Spine Surgery

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Spine Disease
• Intervention / Treatment: Drug: Ropivacaine 0.2% Injectable Solution; Drug: Ropivacaine 0.2% Injectable Solution

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tomasz Reysner, MD PhD; Phone Number: +48 (61) 831-01-22; Email: treysner@ump.edu.pl
• Study Contact Backup: Name: Grzegorz Kowalski, MD PhD; Email: gkowalski@ump.edu.pl

Study Locations

• Poland
  • Poznan, Poland, 62-701
    • Poznan University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: General Anesthesia Alone (GA-only); Participants will receive standardized general anesthesia and multimodal postoperative analgesia according to institutional protocol. No regional anesthesia technique will be performed.
Active Comparator: General Anesthesia + Lumbar Erector Spinae Plane Block (L-ESPB); 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 20 mL per side (total 40 mL). No adjuvants will be used. 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.; Other Names: Lumbar Erector Spinae Plane Block (L-ESPB); Drug: Ropivacaine 0.2% Injectable Solution; Ultrasound-guided bilateral paravertebral block at the lumbar level targeting spinal nerves for postoperative analgesia in patients undergoing lumbar spine surgery.; Other Names: Lumbar Paravertebral Block (L-PVB)
Active Comparator: General Anesthesia + Lumbar Paravertebral Block (L-PVB); 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 20 mL per side (total 40 mL). No adjuvants will be used. 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.; Other Names: Lumbar Erector Spinae Plane Block (L-ESPB); Drug: Ropivacaine 0.2% Injectable Solution; Ultrasound-guided bilateral paravertebral block at the lumbar level targeting spinal nerves for postoperative analgesia in patients undergoing lumbar spine surgery.; Other Names: Lumbar Paravertebral Block (L-PVB)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total opioid consumption within 48 hours after surgery	Total cumulative opioid consumption within the first 48 hours after surgery, converted to intravenous morphine equivalents.	48 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first rescue analgesia	Time from completion of the surgery to the administration of the first dose of rescue opioid analgesic (in minutes).	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	48 hours postoperatively
Interleukin-6 (IL-6) level	serum interleukin-6 (IL-6) level	12 hours after surgery
Interleukin-6 (IL-6) level	serum interleukin-6 (IL-6) level	24 hours after surgery
Interleukin-6 (IL-6) level	serum interleukin-6 (IL-6) level	48 hours after surgery
NLR	neutrophil-to-lymphocyte ratio (NLR)	12 hours after surgery
NLR	neutrophil-to-lymphocyte ratio (NLR)	24 hours after surgery
NLR	neutrophil-to-lymphocyte ratio (NLR)	48 hours after surgery
PLR	platelet-to-lymphocyte ratio (PLR)	12 hours after surgery
PLR	platelet-to-lymphocyte ratio (PLR)	24 hours after surgery
PLR	platelet-to-lymphocyte ratio (PLR)	48 hours after surgery

Collaborators and Investigators

• Sponsor: Poznan University of Medical Sciences
• Investigators: Study Chair: Katarzyna Wieczorowska-Tobis, MD PhD, Poznan University of Medical Sciences; Study Director: Małgorzata Reysner, Md PhD, Poznan University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: May 6, 2026
• First Submitted That Met QC Criteria: May 20, 2026
• First Posted (Actual): May 26, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines; Ropivacaine
• Other Study ID Numbers: 4/2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will be available beginning 6 months after publication of the primary results and will remain available for up to 5 years.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No