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Erector Spinae Plane Block Catheters and Intrathecal Morphine for Hepatic Resection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04849455
Recruitment Status : Recruiting
First Posted : April 19, 2021
Last Update Posted : May 26, 2021
Sponsor:
Information provided by (Responsible Party):
Engy T. Said, MD, University of California, San Diego

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hepatic Resection Acute Pain Anesthesia Anesthesia, Local Drug: 0.2% ropivacaine local anesthetic continuous erector spinae plane block Drug: 0.2% ropivacaine local anesthetic superficially taped continuous erector spinae plane block Drug: Spinal Morphine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Erector Spinae Plane Block Catheters: The Role in Acute Postoperative Pain After Hepatic Resection With Intrathecal Morphine
Estimated Study Start Date : May 24, 2021
Estimated Primary Completion Date : May 1, 2023
Estimated Study Completion Date : May 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)
Drug: 0.2% ropivacaine local anesthetic continuous erector spinae plane block
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)
Other Name: Treatment

Drug: Spinal Morphine
200-300 mcg of spinal morphine

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
Drug: 0.2% ropivacaine local anesthetic superficially taped continuous erector spinae plane block
Placebo- Superficially placed (taped to the surface) erector spinae block catheter with a ropivacaine 0.2% infusion at 0.1ml /hr
Other Name: Placebo

Drug: Spinal Morphine
200-300 mcg of spinal morphine




Primary Outcome Measures :
  1. 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) ]
    Morphine Milligram Equivalents


Secondary Outcome Measures :
  1. Total opioid requirement postoperative day (POD) 0-4 [ Time Frame: Total use from hospital admission to POD 4 (4 days after admission to recovery unit) ]
    Morphine Milligram Equivalents

  2. Pain Score at rest and with cough [ Time Frame: Post-Operative Day 0, 1, 2, 3, 4, 14, 30 ]
    Average pain score on the 10-point numeric rating scale (0 being no pain, 10 worst pain)

  3. Discharge opioids and refills. [ Time Frame: Typically within 14days of admission, then at 14 days, and at 30 days. ]
    Amount of opioids prescribed at discharge and amount taken/refills while at home

  4. Nausea [ Time Frame: Post-Operative Day 0, 1, 2, 3, 4 ]
    Defined by number of antiemetics administered

  5. Time to ambulation [ Time Frame: Post-Operative Day 0, 1, 2, 3, 4 ]
    Able to get out of bed with physical therapy

  6. Time to oral intake [ Time Frame: Post-Operative Day 0, 1, 2, 3, 4 ]
    Diet advancement

  7. Hospital Length Of Stay [ Time Frame: Total number of days requiring hospitalization for surgical procedure. Up to 1 month. ]
    From admission to hospital for surgery to discharge



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

Inclusion Criteria:

  • undergoing hepatic resection
  • Admitting service requests APS consult
  • >18 years old and able to provide consent

Exclusion criteria:

  • pregnancy
  • incarceration
  • inability to communicate with the investigators and hospital staff
  • severe hepatic disease
  • chronic high-dose opioid use (defined as daily use for more than 4 weeks prior to surgery of at least the equivalent of 20 mg oxycodone);
  • BMI > 40 kg/m2
  • allergy to study medications (lidocaine, ropivacaine)

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): NCT04849455


Contacts
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Contact: Engy T Said, MD 5597371904 esaid@health.ucsd.edu

Locations
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United States, California
University of California, San Diego Recruiting
San Diego, California, United States, 92103
Contact: Engy M Said, MD         
Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: Engy T Said, MD University of California, San Diego
Publications:
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Responsible Party: Engy T. Said, MD, Associate Clinical Professor, Anesthesiology., University of California, San Diego
ClinicalTrials.gov Identifier: NCT04849455    
Other Study ID Numbers: 201661
First Posted: April 19, 2021    Key Record Dates
Last Update Posted: May 26, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Engy T. Said, MD, University of California, San Diego:
acute postoperative pain
erector spinae plane block
liver resection
Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations
Morphine
Ropivacaine
Anesthetics, Local
Anesthetics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents