The Pain Control in Rib Fracture With Non-invasive Stabilization (RCT)

NCT05080686 | Unknown

• 1 other identifier: 110-079-F
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

Brief summary: Background: Rib fractures are one of the most common causes of trauma disabilities and have become an important health issue. Patients usually suffer from severe pain. A rapid and adequate pain control is considered as a priority to improve respiratory mechanics and reduce the risk of pulmonary and systemic complications. So far, there was no gold standard regarding pain control for rib fractures. Objective: To assess the effect of the newly-designed Prosthorax Thoraxbelt in addition to oral analgesics on pain control of rib fractures Method: There will be two groups of patients in this study. One group will be the patients with rib fractures who are necessary for in-hospital intense pain control. The other will consist of follow-up patients with rib fractures at an outpatient clinic. The investigators will aim to recruit 30 and 82 patients respectively.

Conditions

Rib Fractures; Pain; Thorax; Fracture

Keywords

Rib fractures; pain control; Posthorax Thoraxbelt

Outcome Measures

Primary Outcomes (2)

• Inpatients: Visual analog scale (VAS)

  A pain score will be assessed to each patient after the total amount of visual analog scale. The minimum is 0 and the maximum is 10, from the least pain to the highest pain.

  48 hours

• Outpatients: Visual analog scale (VAS)

  A pain score will be assessed to each patient after the total amount of visual analog scale. The minimum is 0 and the maximum is 10, from the l

  3 months

Secondary Outcomes (11)

• Inpatients: IV PCA dose

  48 hours

• Inpatients: On-request oral painkiller dose

  48 hours

• Inpatients: Complication during the hospital stay

  48 hours

• Inpatients: Length of hospital stay

  1 month

• Inpatients: VAS before discharge

  3 months

Study Arms (4)

ThoraxBelt (Inpatients)

EXPERIMENTAL

Received ThoraxBelt after the surgery in addition to oral analgesics. Standard care for pain management will be the same as the Standard Care Arm (Inpatients).

Device: Posthorax Thoraxbelt

Standard Care (Inpatients)

NO INTERVENTION

Standard Care with IV PCA and on-request oral painkiller.

ThoraxBelt (Outpatients)

EXPERIMENTAL

Received ThoraxBelt at the emergency room in addition to oral analgesics. Standard care for pain management will be the same as the Standard Care Arm (Outpatients).

Device: Posthorax Thoraxbelt

Standard Care (Outpatients)

NO INTERVENTION

Standard Care and on-request oral painkiller.

Interventions

Posthorax Thoraxbelt DEVICE

The patients will be assisted to put on the ThoraxBelt after surgery or at the emergency room by our research members and will be asked to keep it on except for showering through the whole study period.

ThoraxBelt (Inpatients); ThoraxBelt (Outpatients)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The adult patients with rib fractures (inpatients/outpatients)
• The patients will be assessed to the further admission (inpatients)
• The patients will be assessed to be at follow-up clinic visit (outpatients)

You may not qualify if:

• The accident of rib fractures has been occurred over 24 hours. (inpatients/outpatients)
• Refuse to be arranged to the admission (inpatients)
• Refuse to receive the CT scan (inpatients/outpatients)
• Chest wall infection or other diseases (inpatients/outpatients)
• Chest wall infected by rumors (inpatients/outpatients)
• Pregnancy (inpatients/outpatients)
• Further complications arise (inpatients/outpatients)
• Known allergy to ThoraxBelt (inpatients/outpatients)

Sponsors & Collaborators

• National Taiwan University Hospital Hsin-Chu Branch: lead

Study Sites (1)

National Taiwan University Hospital Hsin-Chu Branch

Hsinchu, 300, Taiwan

RECRUITING

MeSH Terms

Conditions

Rib Fractures; Pain; Fractures, Bone; Agnosia

Condition Hierarchy (Ancestors)

Wounds and Injuries; Thoracic Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Central Study Contacts

Cheng-Yi Fan, M.D.

CONTACT

+886911438312; chengyi.md@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The surgeon will not know the patients' group before or during the surgery. The outcome assessor will not know the group during the whole research.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: October 18, 2021
• Study Start: January 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: July 19, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)