Clinical trial NCT05080686: The Pain Control in Rib Fracture With Non-invasive Stabilization (RCT)
Official title: The Management and Assessment of Pain Control in Rib Fracture With Non-invasive Stabilization: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rib Fractures
Pain
Thorax; Fracture
Keywords: Rib fractures
pain control
Posthorax Thoraxbelt
Lead sponsor: National Taiwan University Hospital Hsin-Chu Branch
Sponsor class: OTHER
First posted: 2021-10-18
Enrollment: 112
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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)

Primary outcomes:
measure: Inpatients: Visual analog scale (VAS)
timeFrame: 48 hours
measure: Outpatients: Visual analog scale (VAS)
timeFrame: 3 months
Secondary outcomes:
measure: Inpatients: IV PCA dose
timeFrame: 48 hours
measure: Inpatients: On-request oral painkiller dose
timeFrame: 48 hours
measure: Inpatients: Complication during the hospital stay
timeFrame: 48 hours
measure: Inpatients: Length of hospital stay
timeFrame: 1 month
measure: Inpatients: VAS before discharge
timeFrame: 3 months
measure: Inpatients: The amount of unanticipated events
timeFrame: 3 months
measure: Inpatients: VAS in outpatient clinic follow-up
timeFrame: 3 months
measure: Inpatients/Outpatients: X-ray examination
timeFrame: 3 months
measure: Inpatients/Outpatients: Compliance on ThoraxBelt after discharge
timeFrame: 3 months
measure: Outpatients: Complication during the follow-up period
timeFrame: 6 months
measure: Outpatients: The amount of unanticipated events
timeFrame: 3 months
Other outcomes:
Locations:
city: Hsinchu
country: Taiwan
facility: National Taiwan University Hospital Hsin-Chu Branch
Study officials:
References: