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/16551916Actively 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
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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
Total: 1 location
1
University of California, San Diego
San Diego, California, United States, 92103
Actively Recruiting
E
Engy T Said, MD
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Lesley De Pietri, Antonio Siniscalchi, Alexia Reggiani...
https://pubmed.ncbi.nlm.nih.gov/16551916Shrijit Nair, Siobhan McGuinness, Fouad Masood...
https://pubmed.ncbi.nlm.nih.gov/31361665