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Continuous Intercostal Nerve Blockade for Traumatic Rib Fractures

NCT02604589 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2017-05-12

Study results available
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Summary

Rib fractures are common injuries in accident patients and can be associated with significant pain during recovery. If poorly controlled, pain from splinting due to rib fractures can result in difficulty in breathing leading to incomplete expansion of lung, and even the need to put a patient on a ventilator to help them breathe. Therefore, pain control is critical in managing patients with rib fractures. To date, many studies have shown the effectiveness of continuous intercostal nerve blockade (a slow release of pain medications at the site of injury that prevents the transmission of pain signals). This approach has never been studied in a randomized fashion in rib fracture patients, and has never been compared to patient-controlled narcotic pain medication, commonly used at many hospitals. The purpose of this study is to evaluate the effectiveness of the placement of an elastomeric infusion pump (a small, external, wearable balloon used to deliver medication over time) attached to a continuous infusion catheter or "soaker" catheter (a tube which releases the pain medication through tiny holes in it, right at the site of injury) to deliver local anesthetic medication to reduce pain caused by two or more rib fractures.

Conditions

  • Rib Fractures

Interventions

DRUG

hydromorphone hydrochloride

Patient-controlled narcotic analgesia pump

PROCEDURE

Infusion catheter placement

Placement of continuous infusion catheter and elastomeric pump into extrathoracic paraspinous space

DRUG

bupivicaine 0.25%

Low Dose analgesia

DRUG

bupivicaine 0.5%

High dose analgesia

Sponsors & Collaborators

  • William Beaumont Hospitals

    collaborator OTHER

  • Anthony Iacco

    lead OTHER

Principal Investigators

  • Anthony Iacco, MD · Beaumont Hospital, Royal Oak MI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02604589 on ClinicalTrials.gov