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

NCT ID: NCT05080686

Last Updated: 2022-07-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2022-12-31

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.

Detailed Description

The study has been approved by the hospital research ethics committee.

Arm1: The management and assessment of pain control in rib fracture with non-invasive stabilization: a randomized controlled trial (inpatients)

Arm2: The management and assessment of pain control in rib fracture with non-invasive stabilization: a randomized controlled trial (outpatients)

Primary outcome:

1. inpatient: Visual analog scale (VAS) for 6 hours, 12 hours and 24 hours after the surgery

2. outpatient: Visual analog scale (VAS) for the times at emergency room; 3 days, 3 weeks and 3 months after rib fracture at an outpatient clinic.

Secondary outcome:

• inpatients

1. The accumulated dose of the inter-venous patient-controlled analgesic drug within 6 hours, 24 hours and 48 hours after the surgery

2. Complication during the hospital stay

3. Hospital stay

4. VAS before discharge

5. Unanticipated events (ICU admission, a second surgery, death)

6. VAS during the 1-week, 1-month and 3-month outpatient clinic visit after the surgery

7. An X-ray examination at an outpatient clinic

8. Compliance on ThoraxBelt after discharge

• outpatients

1. Complication during the follow-up period

2. Unanticipated events (ward admission, ICU admission, a surgery, OHCA)

3. Compliance on ThoraxBelt after discharge

4. An X-ray examination at an outpatient clinic

Conditions

Rib Fractures; Pain; Thorax; Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

ThoraxBelt (Inpatients)

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).

Group Type: EXPERIMENTAL

Posthorax Thoraxbelt

Intervention Type: 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.

Standard Care (Inpatients)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

ThoraxBelt (Outpatients)

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).

Group Type: EXPERIMENTAL

Posthorax Thoraxbelt

Intervention Type: 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.

Standard Care (Outpatients)

Standard Care and on-request oral painkiller.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Posthorax Thoraxbelt

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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)

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital Hsin-Chu Branch

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Taiwan University Hospital Hsin-Chu Branch

Hsinchu, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Cheng-Yi Fan, M.D.

Role: CONTACT

chengyi.md@gmail.com

+886911438312

Facility Contacts

Cheng-Yi Fan, MD

Role: primary

kpfzboekbof@gmail.com

0911438312

Other Identifiers

110-079-F

Identifier Type: -

Identifier Source: org_study_id