NCT03664973

Brief Summary

Patients with ipsilateral multiple rib fractures will be randomized to receive either a single-shot ultrasound-guided serratus plane block, or a continuous serratus plane block within 24h from the chest trauma. Primary outcome is the difference in forced respiratory volume (FEV1) at 72h.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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 2, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

September 3, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 11, 2018

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

June 25, 2025

Status Verified

May 1, 2019

Enrollment Period

5.3 years

First QC Date

September 2, 2018

Last Update Submit

June 20, 2025

Conditions

Chest TraumaChest Pain

Outcome Measures

Primary Outcomes (1)

  • Pulmonary change function

    FEV 1

    day 0 and day 3

Secondary Outcomes (3)

  • Numerical rating scale (NRS) of pain

    day 0, day 1, day 2, day 3, day 4

  • Morphine

    day 0, day 1, day 2, day 3, day 4

  • hospital stay

    day 1, day 2, day 3, day 4, day 5, day 6, day7

Study Arms (2)

continuous

EXPERIMENTAL

continuous local anesthetic infusion (ropivacaine 0.2%)on the serratus plane for at least 72h adds to a Single-shot serratus plane block with ropivacaine 0.37% solution 20 ml.

Procedure: Serratus plane block

single-shot

ACTIVE COMPARATOR

Single-shot serratus plane block with ropivacaine 0.37% solution 20 ml

Procedure: Serratus plane block

Interventions

Serratus plane blockPROCEDURE

Local anesthetic infusion though a peripheral nerve catheter placed on the 5th rib under the serratus plane

continuoussingle-shot

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • o more ipsilateral rib fractures
  • Trauma within 24h from hospital admission
  • Informed consent

You may not qualify if:

  • Chest drain
  • head trauma
  • bilateral rib fractures
  • Intensive care admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AUSL IRCCS Reggio Emilia

Reggio Emilia, 42120, Italy

Location

MeSH Terms

Conditions

Thoracic InjuriesChest Pain

Condition Hierarchy (Ancestors)

Wounds and InjuriesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2018

First Posted

September 11, 2018

Study Start

September 3, 2018

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

June 25, 2025

Record last verified: 2019-05

Locations

IT(1)