Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID04849455

Erector Spinae Plane Block Catheters: The Role in Acute Postoperative Pain After Hepatic Resection With Intrathecal Morphine

Led by University of California, San Diego · Updated on 2022-06-07

70

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether adding erector spinae plane (ESP) catheters to a multimodal pain management plan with intrathecal morphine can improve postoperative pain relief in adults undergoing hepatic resection surgery. This randomized, double-blind, placebo-controlled trial aims to see if the addition of ESP catheters provides better pain control beyond the 24-hour effect of intrathecal morphine, potentially reducing opioid use and improving recovery. The study is conducted at a single center and includes adults able to consent, without gender or racial restrictions. Participants will be randomly assigned to one of two groups: one receiving intrathecal morphine plus active ESP catheters with continuous ropivacaine infusion, and the other receiving intrathecal morphine plus sham ESP catheters with a minimal ropivacaine infusion. Both groups receive the same standard multimodal oral pain regimen and general anesthesia during surgery. The ESP catheters are placed bilaterally at the T7-8 level, with the active group receiving ultrasound-guided catheter placement and a programmed infusion to manage pain over several days. During the study, participants will have assessments of opioid use and pain scores from day 1 to day 3 after surgery, with follow-up through day 30. Researchers will collect data from hospital records and patient interviews to monitor pain control, opioid consumption, nausea, time to ambulation and oral intake, and hospital length of stay. The study measures total opioid use and pain at rest and with coughing, aiming to understand the impact of ESP catheters on postoperative recovery and pain management.

CONDITIONS

Brief Title

Erector Spinae Plane Block Catheters and Intrathecal Morphine for Hepatic Resection

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Undergoing hepatic resection
  • Admitting service requests Acute Pain Service (APS) consult
  • 18 years or older and able to provide consent
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Incarceration
  • Inability to communicate with investigators and hospital staff
  • Severe hepatic disease
  • Chronic high-dose opioid use (daily use for more than 4 weeks before surgery of at least 20 mg oxycodone equivalent)
  • Body mass index (BMI) over 40 kg/m2
  • Allergy to study medications (lidocaine, ropivacaine)

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Hospital stay up to approximately 4 days

Participants undergo hepatic resection surgery and receive either intrathecal morphine with active erector spinae plane (ESP) catheters delivering continuous ropivacaine infusion or intrathecal morphine with superficially taped (sham) ESP catheters. Both groups receive general anesthesia and multimodal pain management according to standard care.

Daily in-person visits during hospitalization

Follow-up

Duration - Up to 30 days after surgery

Participants are followed after hospital discharge to assess pain scores, opioid use, and recovery progress through in-person or telephone interviews.

Follow-up visits or phone calls at days 14 and 30 post-surgery

Trial Site Locations

Total: 1 location

1

University of California, San Diego

San Diego, California, United States, 92103

Actively Recruiting

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Research Team

E

Engy T Said, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

The use of intrathecal morphine for postoperative pain relief after liver resection: a comparison with epidural analgesia.

Lesley De Pietri, Antonio Siniscalchi, Alexia Reggiani...

https://pubmed.ncbi.nlm.nih.gov/16551916