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

The Management and Assessment of Pain Control in Rib Fracture With Non-invasive Stabilization: a Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Pain; Rib Fractures; Thorax; Fracture
• Intervention / Treatment: Device: Posthorax Thoraxbelt

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

• Study Type: Interventional
• Enrollment (Anticipated): 112
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cheng-Yi Fan, M.D.; Phone Number: +886911438312; Email: chengyi.md@gmail.com

Study Locations

• Taiwan
  • Hsinchu, Taiwan, 300
    • Recruiting
    • National Taiwan University Hospital Hsin-Chu Branch
    • Contact: Cheng-Yi Fan, MD; Phone Number: 0911438312; Email: kpfzboekbof@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Device: 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.
No Intervention: Standard Care (Inpatients); Standard Care with IV PCA and on-request oral painkiller.
Experimental: 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).	Device: 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.
No Intervention: Standard Care (Outpatients); Standard Care and on-request oral painkiller.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inpatients: IV PCA dose	the accumulated IV PCA drug dose	48 hours
Inpatients: On-request oral painkiller dose	the accumulated oral painkiller dose	48 hours
Inpatients: Complication during the hospital stay	Any complications whether related to ThoraxBelt or not	48 hours
Inpatients: Length of hospital stay	the amount of days in hospital stay	1 month
Inpatients: VAS before discharge	Visual analog scale before discharge	3 months
Inpatients: The amount of unanticipated events	send to the ICU admission, a second surgery or death	3 months
Inpatients: VAS in outpatient clinic follow-up	VAS during the 1-week, 1-month and 3-month outpatient clinic visit after the surgery	3 months
Inpatients/Outpatients: X-ray examination	An X-ray examination at an outpatient clinic	3 months
Inpatients/Outpatients: Compliance on ThoraxBelt after discharge	How long is the ThroaxBelt removed except during the bath within the whole day. The unit is hour.	3 months
Outpatients: Complication during the follow-up period	Any complications whether related to ThoraxBelt or not	6 months
Outpatients: The amount of unanticipated events	send to the ward admission, ICU admission, a surgery or OHCA	3 months

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital Hsin-Chu Branch

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: October 4, 2021
• First Submitted That Met QC Criteria: October 4, 2021
• First Posted (Actual): October 18, 2021

Study Record Updates

• Last Update Posted (Actual): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 17, 2022
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: pain control; Posthorax Thoraxbelt; Rib fractures
• Additional Relevant MeSH Terms: Wounds and Injuries; Thoracic Injuries; Fractures, Bone; Rib Fractures
• Other Study ID Numbers: 110-079-F

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Currently, we have no plan on sharing the IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No