NCT03890757

Brief Summary

Pain associated with rib movement cause inability to cough and breathe deeply that leads to reduction in the tidal volume and predisposes to significant atelectasis, sputum retention, pneumonia and a reduction in functional residual capacity .These factors in turn lead to decreased lung compliance, ventilation perfusion mismatch, hypoxemia and respiratory distress. Therefore, effective pain relief remains the cornerstone of management to prevent serious respiratory complications .

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
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2019

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 26, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 26, 2019

Status Verified

March 1, 2019

Enrollment Period

7 months

First QC Date

March 17, 2019

Last Update Submit

March 23, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • The primary outcome of this study was to compare ultrasound guided serratus anterior plane block and ultrasound guided paravertebral block as regard the efficacy of analgesia in patients with blunt chest trauma with unilateral multiple rib fractures

    pain will be assessed by the visual analogue scale(VAS)

    VAS will be recorded before performing the technique , this will be the base line record, then it will be compared by the value of VAS 30 minutes after performing the technique and the value of VAS at 1, 3, 6,12 and 24 hours

Secondary Outcomes (1)

  • total dose of rescue analgesia

    the observation will be for 24 hours

Study Arms (1)

serratus anteriorblock

Serratus plane block will be performed with the patient in the lateral position and the arm abducted. Using a high-frequency linear ultrasound probe

Other: ultrasound guided paravertebral or serratus anterior block

Interventions

Patients groups will be as follow: Group (I): Serratus plane block will be performed with the patient in the lateral position and the arm abducted. Using a high-frequency linear ultrasound probe ,Group (II): thoracic paravertebral block will be performed in the sitting position. The spinal level chosen for needle insertion will be two segments below the upper most fractured rib or midway between the upper most and lowest fractured rib, 2-2.5 cm distance from the midline in the same injury site

serratus anteriorblock

Eligibility Criteria

Age20 Years - 70 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsadult malesandfemales
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aging from 20 to 70 years old. - ASA physical status status I-II \-- Patients suffering from blunt chest trauma with unilateral multiple rib fractures.

You may qualify if:

  • ASA physical status status I-II -- Patients suffering from blunt chest trauma with unilateral multiple rib fractures.

You may not qualify if:

  • Epidural or spinal cord haematoma.
  • Thoracic vertebral body fracture.
  • Spinal injury awaiting assessment.
  • Coagulopathy (platelets \<50×109 litre-1, INR\>1.5).
  • Local infection or sepsis.
  • Allergy to local anaesthetic.
  • Inability to position patient due to associated injuries.
  • Severe traumatic brain injury.
  • Unstable lumbar or cervical spinal fractures.
  • Hypotension.
  • Hypovolaemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beni-Suef University Hospital

Banī Suwayf, Egypt

RECRUITING

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Samaa Rashwan, MD

    Assisstant proffesor of anesthesia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Samaa A Rashwan, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
2 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Samaa Abou Alkassem Rashwan

Study Record Dates

First Submitted

March 17, 2019

First Posted

March 26, 2019

Study Start

May 1, 2019

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

March 26, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations