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Erector Spinae Plane (ESP) Versus Paravertebral Nerve (PVB) Blockade for Acute Unilateral Rib Fracture Pain

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ClinicalTrials.gov Identifier: NCT03540095
Recruitment Status : Not yet recruiting
First Posted : May 30, 2018
Last Update Posted : May 31, 2018
Sponsor:
Information provided by (Responsible Party):
Samuel Goldstein, University of Pittsburgh

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rib Fractures Pain, Acute Thoracic Injuries Neuropathic Pain Neuromuscular Blockade Anesthesia, Local Drug: Erector Spinae Plane Block Drug: Paravertebral Nerve Block Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: There are two arms. Our 60 patients will be randomized to either of the two arms and studied in parallel.
Masking: None (Open Label)
Masking Description: We are unable to mask the patient or provider for this study. The interventions are inherently similar, but different, thus making it impossible to blind.
Primary Purpose: Treatment
Official Title: Randomized Prospective Clinical Trial of Erector Spinae Plane (ESP) Versus Paravertebral Nerve (PVB) Blockade for Acute Unilateral Rib Fracture Pain
Estimated Study Start Date : July 1, 2018
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : September 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Erector Spinae Plane Block
The patients randomized to the Erector Spinae Plane Block arm will receive this nerve block at the level corresponding to the rib fractures. Ropivicaine 0.5% 25 mL will be used during the procedure for initiation of pain control. Bupivicaine 0.0625% will be used for continuous infusion of local anesthetic. It will be titrated to effect, at maximum 12 mL/hr. Bupivicaine 0.0625% 3mL will be given every hour as a bolus additionally.
Drug: Erector Spinae Plane Block
See arm description
Other Names:
  • Ropivicaine 0.5%
  • Bupivicaine 0.0625%
  • Braun 18 Ga x 3.5 in TUOHY Epidural Needle
  • Braun 20 Ga CLOSED TIP CATHETER
  • Sonosite X-Porte portable ultrasound machine

Experimental: Paravertebral Nerve Block
The patients randomized to the Paravertebral Nerve Block arm will receive this nerve block at the level corresponding to the rib fractures. Ropivicaine 0.5% 25 mL will be used during the procedure for initiation of pain control. Bupivicaine 0.0625% will be used for continuous infusion of local anesthetic. It will be titrated to effect, at maximum 12 mL/hr. Bupivicaine 0.0625% 3mL will be given every hour as a bolus additionally.
Drug: Paravertebral Nerve Block
See arm description
Other Names:
  • Ropivicaine 0.5%
  • Bupivicaine 0.0625%
  • Braun 18 Ga x 3.5 in TUOHY Epidural Needle
  • Braun 20 Ga CLOSED TIP CATHETER
  • Sonosite X-Porte portable ultrasound machine




Primary Outcome Measures :
  1. Total Opioid Consumption [ Time Frame: first 72 hours after intervention ]

Secondary Outcome Measures :
  1. Visual Analog Scale (VAS) Pain Scores [ Time Frame: Immediately prior to intervention. 15 minutes after intervention. 60 minutes after intervention. Daily (in morning) for 3 total days after intervention. ]
    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.

  2. Adverse Events [ Time Frame: During the expected duration of this study, which is on average 5 days. ]
    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.

  3. Number of Nerve Blocks [ Time Frame: During the expected duration of this study, which is on average 5 days. ]
    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.

  4. Length of Stay [ Time Frame: Will evaluate length of stay upon termination of the last study subject. Expected to be within 6 months of initiation of the trial. ]
    Total length of hospitalization

  5. Time until discharge [ Time Frame: Will evaluate length of stay upon termination of the last study subject. Expected to be within 6 months of initiation of the trial. ]
    Time from intervention to discharge from hospital



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03540095


Contacts
Contact: Samuel Goldstein, MD 6107331743 goldsteinsj@upmc.edu
Contact: Stephanie Nam 4127225477 nams@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center - Presbyterian Hospital Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Samuel Goldstein, MD    610-733-1743    goldsteinsj@upmc.edu   
Contact: Stephanie Nam    4127225477    nams@upmc.edu   
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Samuel Goldstein, MD University of Pittsburgh

Responsible Party: Samuel Goldstein, Anesthesia Resident, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03540095     History of Changes
Other Study ID Numbers: PRO18040578
First Posted: May 30, 2018    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Thoracic Injuries
Fractures, Bone
Neuralgia
Rib Fractures
Acute Pain
Wounds and Injuries
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents