NCT03853330

Brief Summary

To assess the analgesic and respiratory effect of continuous Erector Spinae Plane block versus Thoracic Epidural in patients with multiple fracture ribs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 25, 2019

Completed
9 months until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

March 14, 2022

Status Verified

February 1, 2022

Enrollment Period

2 years

First QC Date

February 20, 2019

Last Update Submit

February 26, 2022

Conditions

Fracture; Rib, Multiple

Outcome Measures

Primary Outcomes (1)

  • Pain score (verbal numeric rating scale) as the median VNRS at rest and cough

    All patients will be assessed for pain score using the 11 points verbal numeric rating scale (VNRS), where zero equals no pain and 10 equals the worst pain imaginable. This assessment will be done before the block and after the block by 60 minutes and then every 6 hours up to 24 hours.

    up to 24 hours

Secondary Outcomes (1)

  • Pulmonary function test

    up to 24 hours

Study Arms (2)

Thoracic Epidural Analgesia group

ACTIVE COMPARATOR

25 patients will receive ultrasound-guided thoracic epidural analgesia for multiple fracture ribs at the level of T8 with 7.5-12 ml of Bupivacaine HCl Inj 0.25% as a loading dose followed by catheter insertion and infusion of Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution at 5-7 ml/h. For breakthrough pain bolus of Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution 5-10 ml can be used.

Device: UltrasoundDrug: Bupivacaine HCl Inj 0.25%Drug: Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution

Erector spinae plane block group

ACTIVE COMPARATOR

25 patients will receive ultrasound-guided ESP block for multiple fracture ribs at the level from T1 to T5 with 7.5-12 ml of Bupivacaine HCl Inj 0.25% as a loading dose followed by catheter insertion and infusion of Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution at 5-7 ml/h. For breakthrough pain bolus of Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution 5-10 ml can be used.

Device: UltrasoundDrug: Bupivacaine HCl Inj 0.25%Drug: Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution

Interventions

UltrasoundDEVICE

Ultrasound-guided Thoracic Epidural Analgesia and Erector spinae plane block.

Erector spinae plane block groupThoracic Epidural Analgesia group
Bupivacaine HCl Inj 0.25%DRUG

Bupivacaine HCl Inj 0.25% will be used in both blocks by the same dose of 7.5-12 ml

Erector spinae plane block groupThoracic Epidural Analgesia group
Bupivacaine Hydrochloride, 0.125%-0.9% Injectable SolutionDRUG

infusion of Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution at 5-7 ml/h will be used in both blocks and also for breakthrough pain after both blocks as a bolus of 5-10 ml.

Erector spinae plane block groupThoracic Epidural Analgesia group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with multiple fracture ribs.

You may not qualify if:

  • Patient refusal.
  • Patients with pre-existing infection at the block site.
  • Coagulopathy.
  • Allergy to local anesthetics.
  • Pre-existing neurological deficits.
  • Psychiatric illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospital

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Fractures, Bone

Interventions

UltrasonographyBupivacaine

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
prospective, double-blinded controlled trial; both the patient and data collector is unaware of the study nature
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. Prof. in Anesthesia and ICU

Study Record Dates

First Submitted

February 20, 2019

First Posted

February 25, 2019

Study Start

December 1, 2019

Primary Completion

December 1, 2021

Study Completion

December 30, 2021

Last Updated

March 14, 2022

Record last verified: 2022-02

Locations

EG(1)