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

Sponsor

National Taiwan University Hospital Hsin-Chu Branch (Other)

Overall Status

Recruiting

CT.gov ID

NCT05080686

Collaborator

(none)

112

Enrollment

Location

Arms

Anticipated Duration (Months)

9.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rib Fractures Pain Thorax; Fracture	Device: Posthorax Thoraxbelt	N/A

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:

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

The accumulated dose of the inter-venous patient-controlled analgesic drug within 6 hours, 24 hours and 48 hours after the surgery
Complication during the hospital stay
Hospital stay
VAS before discharge
Unanticipated events (ICU admission, a second surgery, death)
VAS during the 1-week, 1-month and 3-month outpatient clinic visit after the surgery
An X-ray examination at an outpatient clinic
Compliance on ThoraxBelt after discharge

outpatients

Complication during the follow-up period
Unanticipated events (ward admission, ICU admission, a surgery, OHCA)
Compliance on ThoraxBelt after discharge
An X-ray examination at an outpatient clinic

Study Design

Study Type:

Interventional

Anticipated Enrollment :

112 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

Inpatients: Visual analog scale (VAS) [48 hours]
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.
Outpatients: Visual analog scale (VAS) [3 months]
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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan University Hospital Hsin-Chu Branch	Hsinchu		Taiwan	300

Sponsors and Collaborators

National Taiwan University Hospital Hsin-Chu Branch

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

National Taiwan University Hospital Hsin-Chu Branch

ClinicalTrials.gov Identifier:

NCT05080686

Other Study ID Numbers:

110-079-F

First Posted:

Oct 18, 2021

Last Update Posted:

Jul 19, 2022

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by National Taiwan University Hospital Hsin-Chu Branch

Rib fractures

pain control

Posthorax Thoraxbelt

Additional relevant MeSH terms:

Fractures, Bone

Rib Fractures

Study Results

No Results Posted as of Jul 19, 2022