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

NCT03540095 | Terminated

• 1 other identifier: PRO18040578
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Rib Fractures; Pain, Acute; Thoracic Injuries; Neuropathic Pain; Neuromuscular Blockade; Anesthesia, Local

Outcome Measures

Primary Outcomes (1)

• Total Opioid Consumption

  first 72 hours after intervention

Secondary Outcomes (5)

• Visual Analog Scale (VAS) Pain Scores

  Immediately prior to intervention. 15 minutes after intervention. 60 minutes after intervention. Daily (in morning) for 3 total days after intervention.

• Adverse Events

  During the expected duration of this study, which is on average 5 days.

• Number of Nerve Blocks

  During the expected duration of this study, which is on average 5 days.

• Length of Stay

  Will evaluate length of stay upon termination of the last study subject. Expected to be within 6 months of initiation of the trial.

• Time until discharge

  Will evaluate length of stay upon termination of the last study subject. Expected to be within 6 months of initiation of the trial.

Study Arms (2)

Erector Spinae Plane Block

EXPERIMENTAL

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

Paravertebral Nerve Block

EXPERIMENTAL

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

Interventions

Erector Spinae Plane Block DRUG

See arm description

Also known as: 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

Erector Spinae Plane Block

Paravertebral Nerve Block DRUG

See arm description

Also known as: 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

Paravertebral Nerve Block

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh Medical Center - Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Rib Fractures; Acute Pain; Thoracic Injuries; Neuralgia

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Samuel Goldstein, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesia Resident

Model Details: There are two arms. Our 60 patients will be randomized to either of the two arms and studied in parallel.

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: May 30, 2018
• Study Start: July 23, 2018
• Primary Completion: May 7, 2019
• Study Completion: May 7, 2019
• Last Updated: May 16, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)