Anesthesia Clinical Trial
Official title:
Erector Spinae Plane Block Catheters: The Role in Acute Postoperative Pain After Hepatic Resection With Intrathecal Morphine
NCT number | NCT04849455 |
Other study ID # | 201661 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | May 24, 2021 |
Est. completion date | May 1, 2023 |
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.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | May 1, 2023 |
Est. primary completion date | May 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Diego | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Diego |
United States,
De Pietri L, Siniscalchi A, Reggiani A, Masetti M, Begliomini B, Gazzi M, Gerunda GE, Pasetto A. The use of intrathecal morphine for postoperative pain relief after liver resection: a comparison with epidural analgesia. Anesth Analg. 2006 Apr;102(4):1157-63. — View Citation
Nair S, McGuinness S, Masood F, Boylan JF, Conlon NP. Erector Spinae Plane Blocks in Major Hepatopancreaticobiliary Surgery: A Case Series. A A Pract. 2019 Nov 1;13(9):332-334. doi: 10.1213/XAA.0000000000001069. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total opioid requirement postoperative day (POD) 1-3 | Morphine Milligram Equivalents | 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) | |
Secondary | Total opioid requirement postoperative day (POD) 0-4 | Morphine Milligram Equivalents | Total use from hospital admission to POD 4 (4 days after admission to recovery unit) | |
Secondary | Pain Score at rest and with cough | Average pain score on the 10-point numeric rating scale (0 being no pain, 10 worst pain) | Post-Operative Day 0, 1, 2, 3, 4, 14, 30 | |
Secondary | Discharge opioids and refills. | Amount of opioids prescribed at discharge and amount taken/refills while at home | Typically within 14days of admission, then at 14 days, and at 30 days. | |
Secondary | Nausea | Defined by number of antiemetics administered | Post-Operative Day 0, 1, 2, 3, 4 | |
Secondary | Time to ambulation | Able to get out of bed with physical therapy | Post-Operative Day 0, 1, 2, 3, 4 | |
Secondary | Time to oral intake | Diet advancement | Post-Operative Day 0, 1, 2, 3, 4 | |
Secondary | Hospital Length Of Stay | From admission to hospital for surgery to discharge | Total number of days requiring hospitalization for surgical procedure. Up to 1 month. |
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