NCT03214536

Brief Summary

In spine surgery postoperative pain can often be severe and difficult to treat.With the use of ultrasound, the performance of plane blocks and other techniques like root blocks, facet infiltration have become possible without the use of either unreliable " pop-techniques" or the use of x-ray.The erector spinae block was recently described as a safe and simple and safe technique for neuropathic pain and acute post surgical pain, with effect on the dorsal rami of the spinal nerves and with promising results. In this observational pilot study we want to test the influence of these to blocks on the postoperative pain and opioid consumption after spine fusion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

June 25, 2017

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 11, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2017

Completed
Last Updated

November 14, 2018

Status Verified

November 1, 2018

Enrollment Period

4 months

First QC Date

July 5, 2017

Last Update Submit

November 13, 2018

Conditions

Spine DiseaseRegional Anaesthesia

Keywords

spine surgeryregional anaesthesiaopioid consumptionacute postoperative pain

Outcome Measures

Primary Outcomes (1)

  • 24 hour opioid consumption

    cumulative opioid consumption first 24 hours after block performance

    24 hours from injection ( T0)

Secondary Outcomes (3)

  • sensory block

    30 minutes after block performance

  • motor block

    30 minutes after block performance

  • pain scores

    24 postoperative at regular intervals

Study Arms (1)

erector spinae block

EXPERIMENTAL

bilateral erector spine block with 20 ml 0,375% ropivacaine

Procedure: erector spinae blockDrug: RopivacaineProcedure: Spine surgeryProcedure: anesthesia

Interventions

erector spinae blockPROCEDURE

bilateral injection of local anaesthetic between the erector spinae muscle and the transverse process

erector spinae block
RopivacaineDRUG

injection of 20 ml ropivacaine 0.375 % bilateral by erector spinae block

Also known as: naropin
erector spinae block
Spine surgeryPROCEDURE

Surgery of lumbar spine

erector spinae block
anesthesiaPROCEDURE

general anesthesia

erector spinae block

Eligibility Criteria

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

You may qualify if:

  • Patients planned for laminectomy or back surgery with lumbar pedicle screw placement or revision back surgery

You may not qualify if:

  • patient refusal, bleeding disorder, infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

AZ KLina

Brasschaat, Antwerp, Belgium

Location

University Hospital Antwerp

Edegem, Antwerp, 2650, Belgium

Location

MeSH Terms

Conditions

Spinal DiseasesPain, Postoperative

Interventions

RopivacaineAnesthesia

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesAnesthesia and Analgesia

Study Officials

  • margaretha breebaart, PhD

    University Hospital, Antwerp

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: observational feasibility trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

July 5, 2017

First Posted

July 11, 2017

Study Start

June 25, 2017

Primary Completion

October 30, 2017

Study Completion

October 30, 2017

Last Updated

November 14, 2018

Record last verified: 2018-11

Locations

BE(2)