Erector Spinae Plane Block Catheters and Intrathecal Morphine for Hepatic Resection

NCT04849455 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 201661
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatic Resection; Acute Pain; Anesthesia; Anesthesia, Local

Keywords

acute postoperative pain; erector spinae plane block; liver resection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Total opioid requirement postoperative day (POD) 0-4

  Total use from hospital admission to POD 4 (4 days after admission to recovery unit)

• Pain Score at rest and with cough

  Post-Operative Day 0, 1, 2, 3, 4, 14, 30

• Discharge opioids and refills.

  Typically within 14days of admission, then at 14 days, and at 30 days.

• Nausea

  Post-Operative Day 0, 1, 2, 3, 4

• Time to ambulation

  Post-Operative Day 0, 1, 2, 3, 4

Study Arms (2)

Active Treatment

EXPERIMENTAL

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; Drug: Spinal Morphine

Placebo

PLACEBO COMPARATOR

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; Drug: Spinal Morphine

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)

Also known as: Treatment

Active Treatment

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

Also known as: Placebo

Placebo

Spinal Morphine DRUG

200-300 mcg of spinal morphine

Active Treatment; Placebo

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

San Diego, California, 92103, United States

RECRUITING

Related Publications (2)

• 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. doi: 10.1213/01.ane.0000198567.85040.ce.

  PMID: 16551916 BACKGROUND

• 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.

  PMID: 31361665 BACKGROUND

MeSH Terms

Conditions

Acute Pain; Pain, Postoperative

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Officials

• Engy T Said, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Engy T Said, MD

CONTACT

5597371904; esaid@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor, Anesthesiology.

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: April 19, 2021
• Study Start: May 24, 2021
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: June 7, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)