NCT04473508

Brief Summary

: 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 27, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2020

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 16, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2021

Completed
Last Updated

December 4, 2025

Status Verified

March 1, 2022

Enrollment Period

1.6 years

First QC Date

January 27, 2020

Last Update Submit

November 26, 2025

Conditions

MorphineAdverseEventSpine SurgeryPain Relief

Outcome Measures

Primary Outcomes (1)

  • morphine consumption (mg)

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

    24 Hours after surgery

Secondary Outcomes (7)

  • Adverse events

    from surgery to 3 months

  • pain at rest and at movement: Visual Analogic scale

    Day 1 to Day 3, Day od hospital discharge and month 3

  • chronic pain: DN4 questionnaire

    Questionnaire DN4 at 3 months

  • Length of hospital stay

    hospital length of stay, an average of 4 days

  • Length of stay in the post-intervention care unit

    Day 1

  • +2 more secondary outcomes

Study Arms (2)

Treated

EXPERIMENTAL

active treatment (Local anaesthetic): Local administration of ropivacaine 30 mL (5mg/mL)

Drug: Local administration of ropivacaine

Control

PLACEBO COMPARATOR

Local administration of Placebo ( Saline Solution)

Drug: Local administration of placebo (saline solution)

Interventions

Local administration of ropivacaineDRUG

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

Treated
Local administration of placebo (saline solution)DRUG

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

Control

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Nimes

Nîmes, Gard, 30 000, France

Location

Related Publications (1)

  • Avis G, Gricourt Y, Vialatte PB, Meunier V, Perin M, Simon N, Claret PG, El Fertit H, Lefrant JY, Bertrand M, Cuvillon P. Analgesic efficacy of erector spinae plane blocks for lumbar spine surgery: a randomized double-blind controlled clinical trial. Reg Anesth Pain Med. 2022 Jul 21:rapm-2022-103737. doi: 10.1136/rapm-2022-103737. Online ahead of print.

    PMID: 35863786RESULT

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Geoffrey Avis, Md

    Geoffrey.avis@chu-nimes.fr

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2020

First Posted

July 16, 2020

Study Start

November 27, 2019

Primary Completion

June 25, 2021

Study Completion

September 9, 2021

Last Updated

December 4, 2025

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)