Erector Spinae Plane Blocks in Major Hepatopancreaticobiliary Surgery: A Case Series.
Shrijit Nair, Siobhan McGuinness, Fouad Masood...
https://pubmed.ncbi.nlm.nih.gov/31361665/Actively Recruiting
Led by University of California, San Diego · Updated on 2022-06-07
70
Participants Needed
1
Research Sites
N/A
Total Duration
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
Erector Spinae Plane Block Catheters and Intrathecal Morphine for Hepatic Resection
E
Engy T Said, MD
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
University of California, San Diego
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Erector Spinae Plane Block Catheter (Ropivacaine) | Placebo Erector Spinae Plane Block Catheter |
|---|---|---|
| What it is | A continuous erector spinae plane block catheter delivers ropivacaine (a local anesthetic) close to the spine for regional pain control after liver surgery. Intrathecal (spinal) morphine is administered prior to surgery. | A superficially taped erector spinae plane block catheter delivers only a minimal infusion of ropivacaine and does not provide active regional analgesia. Intrathecal morphine is also given prior to surgery. |
| Role in the trial | Investigational group to assess effectiveness of active continuous erector spinae plane block for pain relief. | Comparator group to measure outcomes against a simulated (placebo) block. |
| Primary use in clinical care | Used for regional pain control after hepatic resection to reduce opioid requirements and improve recovery. | Acts as a placebo to mirror catheter placement with little or no regional analgesia effect. |
| How it is given or performed | After surgical preparation, an erector spinae plane block catheter is placed under ultrasound guidance. Ropivacaine 0.2% is infused continuously with a programmed bolus to provide regional anesthesia. | A catheter is taped superficially to the skin and a minimal dose of ropivacaine is infused so that participants undergo similar procedures without therapeutic effect. |
| Evidence status | Postoperative use of erector spinae plane block catheters is supported by case series and small studies in hepatobiliary surgery, but large, high-quality randomized evidence for effectiveness in hepatic resection is still being developed. | This group provides comparison data to evaluate active block effectiveness; it does not represent a standard treatment. |
| Important limitations | Currently, published evidence for erector spinae plane blocks in hepatic resection is limited to small studies or case series; patient response and safety in broader practice are not yet fully established. | No therapeutic benefit; used only for blinding and assessment in this trial setting. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Shrijit Nair, Siobhan McGuinness, Fouad Masood...
https://pubmed.ncbi.nlm.nih.gov/31361665/Lesley De Pietri, Antonio Siniscalchi, Alexia Reggiani...
https://pubmed.ncbi.nlm.nih.gov/16551916/University of California, San Diego
Lead Sponsor