NCT05983393

Brief Summary

Erector spinae plane (ESP) block is an interfacial plane block with visceral and somatic analgesic activity at paraspinal muscles. This study aims to examine the postoperative analgesic efficacy of ESP block in patients undergoing posterior spinal instrumentation

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable pain

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

September 1, 2021

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2023

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 9, 2023

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

1.9 years

First QC Date

August 1, 2023

Last Update Submit

October 6, 2023

Conditions

PainPost Operative Pain

Keywords

Painpostoperative analgesiaErector spinae plane blockposterior spinal instrumentation

Outcome Measures

Primary Outcomes (1)

  • opioid consumption

    The amount of morphine consumed in milligrams in the first 24 hours was determined with a patient-controlled analgesia pump.

    up to 24 hour

Study Arms (2)

Control group

SHAM COMPARATOR

No block was performed

Procedure: Control

Erector spinae plane block

ACTIVE COMPARATOR

Erector spinae plane block was performed, morphine was administered with patient-controlled analgesia (PCA) and all patients were followed in the ward.

Procedure: Erector spinae plane block

Interventions

Erector spinae plane blockPROCEDURE

Erector spinae plane block was performed

Erector spinae plane block
ControlPROCEDURE

Erector spinae plane block was not applied.

Control group

Eligibility Criteria

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

You may qualify if:

  • ASA I-III patients
  • Agreed to participate in the study

You may not qualify if:

  • Patients with infection at the injection site
  • Coagulopathy Allergy to amide-type local anesthetics
  • History of peripheral neuropathy
  • Hepatic and/or renal failure
  • Refusing the procedure
  • Patients with heart disease
  • Patients who have previously undergone surgery from the same area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaras Sutcu Imam University Hospital

Kahramanmaraş, 46100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainPain, Postoperative

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Study Officials

  • Gökce Gişi

    Kahramanmaras Sutcu Imam Universty

    PRINCIPAL INVESTIGATOR

  • Gözen Öksüz

    Kahramanmaras Sutcu Imam Universty

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 1, 2023

First Posted

August 9, 2023

Study Start

September 1, 2021

Primary Completion

August 7, 2023

Study Completion

August 7, 2023

Last Updated

October 10, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)