NCT04554186

Brief Summary

Compare between serratus anterior plane block and thoracic Paravertebral block in analgesia for patients with multiple rib fractures

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

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

September 12, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 18, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

September 22, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2021

Completed
Last Updated

September 23, 2020

Status Verified

September 1, 2020

Enrollment Period

3 months

First QC Date

September 12, 2020

Last Update Submit

September 22, 2020

Conditions

Keywords

Fracture ribTPVBSAPB

Outcome Measures

Primary Outcomes (1)

  • VAS score

    Visual analogue pain score describe by the patient

    24 hour

Secondary Outcomes (1)

  • Total analgesic consumption

    24 hour

Study Arms (3)

Serratus anterior plane block

EXPERIMENTAL

20 patients will receive SAP block with 0.4 ml / kg bupivacaine 0.125% then continuous infusion through a catheter at rate of 7 ml / hour to max 10 ml / hour of bupivacaine 0.0625%

Procedure: Serratus anterior plane block

Thoracic Paravertebral block

ACTIVE COMPARATOR

20 patients will receive TPVB 0.4ml / kg bupivacaine 0.125% then continuous infusion through a catheter at rate of 7 ml / hour to max 10 ml / hour of bupivacaine 0.0625%

Procedure: Thoracic Paravertebral block

Control group

PLACEBO COMPARATOR

20 patients will receive Fentanyl patch 50 microgram

Procedure: Control

Interventions

Injection of bupivacaine between serratus anterior plane and latissimus dorsi muscle using ultrasound

Serratus anterior plane block

Injection of bupivacaine in the thoracic Paravertebral space using ultrasound

Thoracic Paravertebral block
ControlPROCEDURE

Place a fentanyl patch 50 microgram

Control group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ASA 1\_3 Age 18\_60 Unilateral fracture ribs

You may not qualify if:

  • Drug allergy Morbid obese Opioid dependence Patients refuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minia university hospital

Minya, 61511, Egypt

RECRUITING

MeSH Terms

Conditions

Rib FracturesAgnosia

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesThoracic InjuriesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Amany K Aboelhassan

    Minia University Hospital

    STUDY CHAIR

Central Study Contacts

Ahmed G Shehata, Master

CONTACT

Omyma M Shehata, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

September 12, 2020

First Posted

September 18, 2020

Study Start

September 22, 2020

Primary Completion

January 1, 2021

Study Completion

January 15, 2021

Last Updated

September 23, 2020

Record last verified: 2020-09

Locations