Health TrialsbyHealthPanel

INTERCOSTAL NERVE BLOCK: Efficacy of CINB for Patients With Multiple Rib Fractures

ConditionRib Fractures
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorZachary Warriner

About this trial

This is a prospective, randomized, non-blinded study comparing CINB plus medical therapy versus standard medical care (non-steroidals and opioids intravenous/oral inpatient and oral outpatient) alone for patients with multiple rib fractures. The objective of this study is to analyze the effect of continuous intercostal nerve block (CINB) in the treatment of patients admitted to the adult trauma service with rib fractures. The effectiveness of CINB as adjunctive treatment will be compared to standard medical therapy involving nonsteroidal and intravenous/oral opioid medications.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects will be at least 18 years old

Subjects will have 2 or more identified rib fractures

Subjects will be willing to provide informed consent for procedure

Subjects will be identified as appropriate for initiation of continuous nerve block therapy for treatment of rib fracture associated pain.

Disqualifiers

Documented allergy to study medication

Epidural catheter use

Prisoners

Refusal of CINB therapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ropivacaine

    Drug

    Patients in this group will receive CINB (continuous local intercostal infusion of 0.2% Ropivacaine). A single catheter will be placed for short segment involvement and two catheters will be placed in series for longer segments of involvement. If necessary and as part of standard of care, CINB treatment will continue after patient discharge. The administration of CINB therapy will continue in the same manner as inpatient therapy.

  • Non steroidal anti-inflammatory drug and opioids

    Drug

    Patients in this group receive nonsteroidal and opioid pain medications (intravenous/oral inpatient and oral outpatient) per standard of care.

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: continuous intercostal nerve block (CINB)Experimental treatment 2 interventions
Group B: standard medical careActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Length of hospital stay

time from randomization until the time of discharge

Time frame
7 days

Secondary outcomes

1

Patient daily pain scores

Pain will be assessed using a 10-Point Numerical Pain Scale (as part of standard of care) every day while patient is hospitalized and 2 days following discharge at follow contact. Scores range from 0-10; higher scores indicated higher levels of pain.

Time frame
7 days
2

Modified Morphine Equivalent (MME) differences

Total morphine milligram equivalents (MME) will be assessed

Time frame
7 days
3

hospital-free days

number of outpatient days for 1 month following randomization

Time frame
30 days
4

spirometry values

measurements of inspiratory volume in milliliters will be taken pre-placement, 60 minutes after catheter insertion, the following day, and each subsequent morning

Time frame
7 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zachary Warriner

Lead sponsor

University of Kentucky

Sponsor institution

Source ClinicalTrials.gov
Apply now