Neuropathic Pain Clinical Trial
Official title:
Randomized Prospective Clinical Trial of Erector Spinae Plane (ESP) Versus Paravertebral Nerve (PVB) Blockade for Acute Unilateral Rib Fracture Pain
NCT number | NCT03540095 |
Other study ID # | PRO18040578 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | July 23, 2018 |
Est. completion date | May 7, 2019 |
Verified date | May 2019 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 7 |
Est. completion date | May 7, 2019 |
Est. primary completion date | May 7, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh Medical Center - Presbyterian Hospital | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total Opioid Consumption | first 72 hours after intervention | ||
Secondary | Visual Analog Scale (VAS) Pain Scores | Visual Analog Scale is numerical from 0-10, with 10 being the worst pain imaginable, and 0 being no pain. The pain score will be recorded at rest and with deep breathing at the time intervals below. There are no subscales involved in this measurement. Simply, we will record single pain scores by VAS scale at rest and with deep breathing at indicated times. | Immediately prior to intervention. 15 minutes after intervention. 60 minutes after intervention. Daily (in morning) for 3 total days after intervention. | |
Secondary | Adverse Events | We will record total number of pneumothoraxes, site infections, significant bleeding events, and unintentional catheter removals. Each of these events will be added separately per patient. We will analyze how many patients experience any adverse effect, and then further study the incidence of each specific adverse effect and compare them across both interventions. | During the expected duration of this study, which is on average 5 days. | |
Secondary | Number of Nerve Blocks | The provider will use his/her judgement to determine how many nerve blocks are required for management of the rib fracture pain. Compare the number of nerve blocks required for each type of intervention in the separate arms. | During the expected duration of this study, which is on average 5 days. | |
Secondary | Length of Stay | Total length of hospitalization | Will evaluate length of stay upon termination of the last study subject. Expected to be within 6 months of initiation of the trial. | |
Secondary | Time until discharge | Time from intervention to discharge from hospital | Will evaluate length of stay upon termination of the last study subject. Expected to be within 6 months of initiation of the trial. |
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