Continuous Erector Spinae Plane Blocks for Rib Fractures

NCT04558281 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: cESPB for Rib Fractures
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

Rib fractures are one of the most common injuries in trauma patients. These fractures are associated with significant pain as well as decreased ability to inspire deeply or cough to clear secretions, which together lead to complications of the lungs and breathing which leads to risks of further injury and even death. One recent study found that the ability to move air into and out of the lungs practically doubled with the administration of a single-injection Erector Spainae Plane Block (ESPB) while pain levels nearly halved. However, a single-injection nerve block lasts less than 24 hours while a perineural local anesthetic infusion (also termed a "continuous peripheral nerve block") may be administered for multiple days. This entails inserting a tiny tube through the skin and into the area around the nerves, after which more local anesthetic may be administered prolonging the numbing effects. The possibility of extending the duration of a ESPB with local anesthetic administration via a perineural catheter has not be investigated. We therefore are conducting a randomized, triple-masked, placebo-controlled, parallel-arm study to investigate the addition of a continuous ESPB to a single-injection ESPB following traumatic rib fractures. The primary outcome of this study will be the maximum inspired volume measured by incentive spirometry on the afternoon following the nerve block procedure. We hypothesize that the maximum inspired volume will be significantly increased in the afternoon following the procedure with the addition of a continuous ESPB to a single-injection ESPB.

Conditions

Rib Fractures; Trauma; Anesthesia; Anesthesia, Local

Outcome Measures

Primary Outcomes (1)

• Maximal Inspired Volume - Absolute

  Measured via a handheld incentive spirometer. The best of three measurements will be recorded as the maximum inspired volume.

  Between 1200 and 1700 on the day following the procedure

Secondary Outcomes (10)

• Maximal Inspired Volume - Absolute

  Afternoons on postoperative days 2 and 7, postoperative months 0.5, 1, 1.5, 2, 3, 6, and 12

• Maximal Inspired Volume - Percentage Change From Baseline Prior to Intervention

  Afternoons on postoperative days 1, 2 and 7, postoperative months 0.5, 1, 1.5, 2, 3, 6, and 12

• Brief Pain Inventory (Short Form, Interference Subscale)

  Months 0.5, 1, 1.5, 2, 3, 6, 12 following procedure

• Rib Fracture Pain When Using an Incentive Spirometer

  Days 1, 2, and 7, and months 0.5, 1, 1.5, 2, 3, 6, 12 following procedure

• WORST Rib Fracture Pain in Previous 24 Hours

  Days 1, 2, and 7, and months 0.5, 1, 1.5, 2, 3, 6, 12 following procedure

Study Arms (2)

Active Treatment

EXPERIMENTAL

This group will receive a single injection nerve block of ropivacaine 0.5% (20 mL) followed by an infusion/boluses of ropivacaine 0.3% (continuous block)

Drug: Active ropivacaine 0.3% erector spinae plane perineural administration

Placebo

PLACEBO COMPARATOR

This group will receive a single injection nerve block of ropivacaine 0.5% (20 mL) followed by an infusion/boluses of normal saline

Drug: Placebo erector spinae plane perineural administration

Interventions

Active ropivacaine 0.3% erector spinae plane perineural administration DRUG

Ropivacaine 0.3% administration via an erector spinae plane perineural catheter

Active Treatment

Placebo erector spinae plane perineural administration DRUG

Normal saline administration via an erector spinae plane perineural catheter

Placebo

Eligibility Criteria

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

You may qualify if:

• having a total of 1-6 rib fractures at least 3 cm distal to the costo-transverse joint (bilateral fractures are acceptable, but the total of the two sides combined must not exceed 6 fractures)
• regional anesthetic requested by the admitting service
• patient accepting of a perineural catheter insertion and subsequent study fluid treatment.

You may not qualify if:

• chronic opioid use (daily use within the 2 weeks prior to presentation and duration of use \> 4 weeks; of note, any testing for opioid use will not occur as part of the study, but may as standard of care)
• pregnancy
• incarceration
• inability to communicate with the investigators
• weight \< 45 kg or morbid obesity (body mass index \> 40 kg/m2)
• comorbidity precluding either perineural catheter insertion or subsequent ambulatory perineural local anesthetic administration (e.g., current infection at the catheter insertion site, known hepatic or renal insufficiency, immune-compromised status of any etiology)
• any patient unable to correctly perform incentive spirometry as this is the primary outcome measure
• any patient with any degree of decreased mental capacity as determined by the surgical service
• any reason an investigator believes study participation would not be in the best interest of the potential subject
• flail chest
• chest tube
• fracture of the 1st rib on either side
• any injury other than the rib fracture(s) that potentially effects inspiratory effort or volume (e.g., clavicle fracture)
• inability to contact the investigators during the perineural administration, and vice versa (e.g., lack of telephone access).

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University California San Diego

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Rib Fractures; Wounds and Injuries

Condition Hierarchy (Ancestors)

Fractures, Bone; Thoracic Injuries

Results Point of Contact

• Title: Brian Ilfeld, MD, MS
• Organization: University of California San Diego

bilfeld@health.ucsd.edu

(858) 822-0776

Study Officials

• John J Finneran IV, MD

  University of California, San Diego

  STUDY DIRECTOR

• Brian M Ilfeld, MD, MS

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study solution containing either local anesthetic (ropivacaine) or saline will be prepared by the UCSD Investigational Drug Study Service. Both ropivacaine and normal saline are clear and indistinguishable visually.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Residence

Model Details: Randomized, double-masked, placebo-controlled, parallel group clinical study

Study Record Dates

• First Submitted: September 13, 2020
• First Posted: September 22, 2020
• Study Start: May 23, 2021
• Primary Completion: March 26, 2022
• Study Completion: March 24, 2023
• Last Updated: June 12, 2023
• Results First Posted: June 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)