Erector Spinae Plane Block Catheters and Intrathecal Morphine for Hepatic Resection

Part of paid clinical trials in San Diego, California.

Sponsor
University of California, San Diego
Study ID
NCT04849455
Phase
PHASE4
Status
Recruiting
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Conditions

  • Acute Pain
  • Anesthesia
  • Anesthesia, Local
  • Hepatic Resection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 0.2% ropivacaine local anesthetic continuous erector spinae plane block — DRUG
    Treatment- continuous erector spinae block catheter followed by an infusion of ropivacaine 0.2% at 10ml automatic set bolus per 60 minute with 2ml/hr continuous infusion (12mls/hr total per catheter)
  • 0.2% ropivacaine local anesthetic superficially taped continuous erector spinae plane block — DRUG
    Placebo- Superficially placed (taped to the surface) erector spinae block catheter with a ropivacaine 0.2% infusion at 0.1ml /hr
  • Spinal Morphine — DRUG
    200-300 mcg of spinal morphine

Study Details

To determine whether the addition of erector spinae plane (ESP) catheters to existing multimodal analgesic regimen with intrathecal morphine provides superior postoperative analgesia in patients undergoing hepatic resection compared with patients not receiving ESP catheters.

Key Dates

Start date
May 24, 2021
Status verified
Jun 2022
Primary completion
May 1, 2023
Completion
May 1, 2023

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active Treatment
    This group will receive a continuous erector spinae block catheter followed by an infusion of ropivacaine 0.2% at 10ml automatic set bolus per 120 minutes with 2ml/hr continuous infusion (14mls total every 2 hours per catheter)
  • Placebo Comparator: Placebo
    This group will receive a superficially placed (taped to the surface) erector spinae block catheter with a ropivacaine 0.2% infusion at 0.1ml /hr

Primary Outcome Measure

Total opioid requirement postoperative day (POD) 1-3 [ Time Frame: Total use from post-operative day (POD) 1, as defined by 24 hours after intrathecal morphine, to POD 3 (3 days from admission to recovery unit) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San DiegoSan DiegoCalifornia92103
Engy M Said, MD

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University of California, San Diego· San Diego, CA

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