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

ConditionSpine Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-100
SponsorPoznan University of Medical Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Refusal to participate

Chronic opioid therapy

Coagulation disorders

Use of anticoagulant therapy contraindicating regional anesthesia

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Ropivacaine 0.2% Injectable Solution

    Drug

    Ultrasound-guided bilateral paravertebral block at the lumbar level targeting spinal nerves for postoperative analgesia in patients undergoing lumbar spine surgery.

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: General Anesthesia Alone (GA-only)No intervention 0 interventions
Group B: General Anesthesia + Lumbar Erector Spinae Plane Block (L-ESPB)Active comparator 1 intervention
Group C: General Anesthesia + Lumbar Paravertebral Block (L-PVB)Active comparator 1 intervention

Trial outcomes

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.

Time frame
48 hours postoperatively

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Poznan University of Medical Sciences

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: