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Completed

NCT Number: NCT04473508

Erectus Nerve Block for Lumbar Spine Surgery

: Spine surgery induced severe postoperative pain. Several techniques as intravenous multimodal analgesia have been proposed to reduce pain relief and morphine rescue over the first postoperative days. Regional anesthesia using the erectus nerve block is a simple infiltration across lamina of the vertebra: Ultrasound-guided posterior ramus of spinal nerve block for anesthesia and analgesia in lumbar spinal surgery This study compared erector nerve block with local anesthetic vs placebo to reduce pain and morphine rescue after lumbar spine surgery. The investigators hypothesized that eructor nerve block induced a large block from L1 to L5 that induced posterior nerve roots block anesthesia. This block reduced pain after surgery.

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Key information

Conditions

Spine Surgery AdverseEvent Morphine Pain Relief

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Nimes

Nîmes, Gard, 30 000, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age> 18years and <80 years
  • lumbar spine surgery (2-4 levels)
  • posterior approach
  • ASA 1-3

Exclusion criteria

  • refusal
  • age < 18yrs
  • <50 kg and >120 kg
  • pregnant
  • renal or hepatic severe desease
  • ASA 4
  • no French speaking
  • emergency surgery
  • local or systemic infection
  • surgical resumption of the surgical site
  • surgery involving a thoracic approach
  • allergy to local anesthetics

Treatment and study plan

Local administration of ropivacaine

Drug

Erector nerve block with local ropivacaine injection in addition with conventional anesthesia for spine surgery

Local administration of placebo (saline solution)

Drug

injection of saline solution in addition with conventional anesthesia for spine surgery

Primary outcomes

  1. morphine consumption (mg)

    Time frame: 24 Hours after surgery

    Quantity administered in the post-interventional monitoring room and in hospitalization via a self-controlled morphine pump by the patient

Secondary outcomes

  1. Adverse events

    Time frame: from surgery to 3 months

    Nausea, vomiting, confusion, urinary retention, hematoma, reintervention

  2. pain at rest and at movement: Visual Analogic scale

    Time frame: Day 1 to Day 3, Day od hospital discharge and month 3

    Visual Analogic scale of pain (0-10)

  3. chronic pain: DN4 questionnaire

    Time frame: Questionnaire DN4 at 3 months

    pain score as mesured with DN4 questionnaire

  4. Length of hospital stay

    Time frame: hospital length of stay, an average of 4 days

    Number of day in hospital

  5. Length of stay in the post-intervention care unit

    Time frame: Day 1

    Number of minutes that patient stay in post intervention care unit in minutes

  6. Patient Satisfaction: visual analogic scale

    Time frame: Day of hospital discharge, an average of day 4

    Patient satisfaction mesured with a visual analogic scale (0-10)

  7. Patient Quality of life: EQ-5D Questionnaire

    Time frame: 3 months

    Patient Quality of life mesured with EQ-5D Questionnaire

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

Erectus Nerve Block for Lumbar Spine Surgery : a Prospective Randomized Study

Acronym: EFABE

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 16, 2020
Registry last updated
Dec 4, 2025

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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