NCT04028154

Brief Summary

Lumbar vertebra surgery is one of the most common surgical procedures. After lumbar veretebra surgery, patients complain of excessive pain. Postoperative pain usually occurs in the early postoperative period and delays patient mobilization and thus lengthens hospital stay. The aim of this study was to compare the efficacy of erector spina plan(ESP) block and thoraco lumbar interfacial(TLIP) block on postoperative pain in patients with spinal surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

July 16, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 22, 2019

Completed
1.2 years until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

September 23, 2020

Status Verified

September 1, 2020

Enrollment Period

1 year

First QC Date

July 16, 2019

Last Update Submit

September 21, 2020

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (6)

  • NRS(numerical rating scala)

    Each item is scored 0-10 ( 0=no pain, 10= pain as bad as can be) Postoperative pain intensity reported with NRS score : 30. minute, 1. hours, 6. hours, 12. hours, 24. hours

    [Time Frame: 24 hours]

  • pruritus

    each criterion is reported as present or absent each criterion is reported as present or absent

    [Time Frame: 24 hours]

  • mobilized

    each criterion is reported as when the patient is mobilized

    [Time Frame: 7 days]

  • nausea and vomiting

    each criterion is reported as present or absent each criterion is reported as present or absent

    [Time Frame: 24 hours]

  • use of antiemetics

    each criterion is reported as present or absent each criterion is reported as present or absent

    [Time Frame: 24 hours]

  • discharged

    each criterion is reported as when the patient is discharged

    [Time Frame: 7 days]

Study Arms (2)

ESP Block

EXPERIMENTAL
Procedure: Erector Spinae Plane (ESP) Block

TLIP Block

ACTIVE COMPARATOR
Procedure: Thoracolumbar interfacial plane (TLIP) Block

Interventions

Erector Spinae Plane (ESP) BlockPROCEDURE

ESP Block: Bilateral ESP block and with ultrasound guidance will be applied A total 40 ml, 20 ml bupivacaine 0.5%, 20 ml saline.

ESP Block
Thoracolumbar interfacial plane (TLIP) BlockPROCEDURE

TLIP Block: BilateralTLIP block and with ultrasound guidance will be applied A total 40 ml, 20 ml bupivacaine 0.5%, 20 ml saline.

TLIP Block

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients
  • ASA I-III,
  • Aged 18-75 years
  • underwent lumbar spine surgery under elective conditions

You may not qualify if:

  • Presence of contraindications to LA agents used in this study
  • Use of chronic opioids,
  • Psychiatric disorders.
  • The presence of infection at the injection area.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department

Aydin, 09100, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Almeida CR, Oliveira AR, Cunha P. Continuous Bilateral Erector of Spine Plane Block at T8 for Extensive Lumbar Spine Fusion Surgery: Case Report. Pain Pract. 2019 Jun;19(5):536-540. doi: 10.1111/papr.12774. Epub 2019 Mar 15.

    PMID: 30758122BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

ParapsychologyDental Occlusion

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavioral SciencesBehavioral Disciplines and ActivitiesDentistryDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Sinem Sarı

    Aydin Adnan Menderes University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

sinem sarı

CONTACT

905075396313sarısinem@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., clinical research

Study Record Dates

First Submitted

July 16, 2019

First Posted

July 22, 2019

Study Start

October 1, 2020

Primary Completion

October 1, 2021

Study Completion

December 1, 2021

Last Updated

September 23, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)