Erector Spinae Plane (ESP) Versus Paravertebral Nerve (PVB) Blockade for Acute Unilateral Rib Fracture Pain
Stopped early · Not applicable
Conditions studied: Rib Fractures, Pain, Acute, Thoracic Injuries, Neuropathic Pain, Neuromuscular Blockade, Anesthesia, Local
In brief
Continuous paravertebral analgesia and erector spinae plane blockade (ESP) are accepted techniques at University of Pittsburgh Medical Center (UPMC) for the management of thoracic pain following surgery and trauma. Recently, an increasing number of erector spinae plane blocks are being performed as it has been demonstrated in our institution and via case reports that they provide clinical effectiveness, but may have a better side-effect profile than the paravertebral nerve block. However, the relative efficacy of ESP and continuous paravertebral analgesia for patients with rib fractures remains to be established. This study will include 60 consecutive patients presenting to the UPMC Presbyterian Acute Interventional Perioperative Pain Service suffering from unilateral rib fractures and will be randomized to receive either nerve blocks via continuous paravertebral infusion or via erector spinae plane infusion. In addition, to treat breakthrough pain, the patients in both arms will receive multimodal adjunctive therapy per routine. Bupivicaine and ropivicaine are FDA approved for use in nerve block catheters. The primary outcome will be total opioid consumption in the first 3 days of nerve block. Secondary outcomes include highest visual analog pain score (VAS) with deep breathing and at rest, adverse events, and total number of nerve blocks. Other data points include time to readiness for discharge, and length of hospital stay.
Key facts
- Study ID
- NCT03540095
- Run by
- University of Pittsburgh
- People needed
- 7
- Starts
- 2018-07-23
- Expected to finish
- 2019-05-07
- Last updated by the study team
- 2019-05-16
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age between 18-85 years
- no contraindications to the placement of a paravertebral catheter or erector spinae plane catheter
- American Society of Anesthesiologists physical status between I-IV
- no chronic opioid use
- patients who are not expected to be on therapeutic anticoagulants post-procedurally
- no clopidogrel in last 48 hours
- no known allergies to any of the drugs/agents used study protocol
- no personal or family history of malignant hyperthermia
- not pregnant
- not having an altered mental status (oriented to place, person, or time)
- no comorbid condition(s) that in the judgment of the anesthesiologist, would preclude the patient from any aspect of the study. Comorbid conditions include bleeding disorders, thrombocytopenia, localized infection, sepsis, possibly abnormalities of the thoracic spine or paravertebral anatomy neoplastic mass occupying the paravertebral space, empyema, allergy to local anesthestic drug, increased intracranial pressure, severe uncorrected hypovolemia, fixed cardiac output states.
You may not qualify if…
- Age younger than 18 years or older than 85 years
- any contraindication to the placement of a paravertebral or erector spinae catheters
- American Society of Anesthesiologists physical status V or greater
- chronic opioid use
- coagulation abnormalities or patients who are expected to be on therapeutic anticoagulants postprocedurally
- clopidogrel use within 48 hours
- allergy to any of the drugs/agents used study protocol
- personal or family history of malignant hyperthermia
- pregnancy
- having an altered mental status (not oriented to place, person, or time), (11) any comorbid condition that in the judgment of the anesthesiologist would preclude the patient from any aspect of the study
- patient refusal. Comorbid conditions include bleeding disorders, thrombocytopenia, localized infection, sepsis, possibly abnormalities of the thoracic spine or paravertebral anatomy neoplastic mass occupying the paravertebral space, empyema, allergy to local anesthetic drug, increased intracranial pressure, severe uncorrected hypovolemia, fixed cardiac output states.
Where it is running
- University of Pittsburgh Medical Center - Presbyterian Hospital — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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