Clinical trial

The Efficacy of Continuous Intercostal Nerve Blocks in the Treatment of Patients With Multiple Rib Fractures

NCT05642026

Name

SURMI-22-INTERCOSTAL-NB

Description

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.

Trial arms

Trial start

2024-06-01

Estimated PCD

2024-12-01

Trial end

2024-12-31

Status

Recruiting

Phase

Early phase I

Treatment

Ropivacaine

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.

Arms:

continuous intercostal nerve block (CINB)

Other names:

Naropin

Non steroidal anti-inflammatory drug and opioids

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

Arms:

continuous intercostal nerve block (CINB), standard medical care

Size

180

Primary endpoint

Length of hospital stay

7 days

Eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * Documented allergy to study medication * Epidural catheter use * Prisoners * Refusal of CINB therapy

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 180, 'type': 'ESTIMATED'}}

Updated at

2024-05-31

1 organization

2 products

1 indication

Organization

Zachary Warriner

Product

Ropivacaine

Indication

Rib Fractures

Product

Non steroidal anti-inflammatory drug and opioids