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

NCT07607509 | Not Yet Recruiting

• 1 other identifier: 4/2026
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Spine Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (22)

• Time to first rescue analgesia

  48 hours after surgery

• Postoperative pain intensity at rest (NRS)

  0 hours postoperatively

• Postoperative pain intensity at rest (NRS)

  2 hours postoperatively

• Postoperative pain intensity at rest (NRS)

  6 hours postoperatively

• Postoperative pain intensity at rest (NRS)

  12 hours postoperatively

Study Arms (3)

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 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

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 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

Interventions

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.

Also known as: Lumbar Erector Spinae Plane Block (L-ESPB)

General Anesthesia + Lumbar Erector Spinae Plane Block (L-ESPB)

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (1)

Poznan University of Medical Sciences

Poznan, 62-701, Poland

Location

MeSH Terms

Conditions

Spinal Diseases

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Katarzyna Wieczorowska-Tobis, MD PhD

  Poznan University of Medical Sciences

  STUDY CHAIR

• Małgorzata Reysner, Md PhD

  Poznan University of Medical Sciences

  STUDY DIRECTOR

Central Study Contacts

Tomasz Reysner, MD PhD

CONTACT

+48 (61) 831-01-22; treysner@ump.edu.pl

Grzegorz Kowalski, MD PhD

CONTACT

gkowalski@ump.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 26, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: May 26, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.

Locations

PL (1)