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

National Taiwan University Hospital Hsin-Chu Branch

Status: Unknown

Conditions: Thorax; Fracture; Rib Fractures; Pain

Treatments: Device: Posthorax Thoraxbelt

Study type: Interventional

Funder types: Other

Identifiers

NCT05080686

110-079-F

Details and patient eligibility

About

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.

Full 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

Enrollment: 112 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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112 participants in 4 patient groups

ThoraxBelt (Inpatients)

Experimental group

Description:

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).

Treatment:

Device: Posthorax Thoraxbelt

Standard Care (Inpatients)

No Intervention group

Description:

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

ThoraxBelt (Outpatients)

Experimental group

Description:

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).

Treatment:

Device: Posthorax Thoraxbelt

Standard Care (Outpatients)

No Intervention group

Description:

Standard Care and on-request oral painkiller.