Ropivacaine Plasma Concentration With or Without Epinephrine for Posterior Quadratus Lumborum Block (NCT04562103) | Clinical Trial Compass
CompletedNot Applicable
Ropivacaine Plasma Concentration With or Without Epinephrine for Posterior Quadratus Lumborum Block
Italy52 participantsStarted 2020-07-03
Plain-language summary
Introduction The posterior Quadratus Lumborum Block (pQLB) has been used in postoperative pain management after Cesarean Section (CS). However, there are no data about pQLB safety in pregnants, at increased risk of local anesthetic systemic toxicity (LAST). The purpose of the present study was to explore the efficacy and the safety of adding epinephrine to ropivacaine for bilateral pQLB vs. bilateral pQLB performed with ropivacaine alone in CS.
Methods Fifty-two pregnants were consecutively allocated to one of 2 groups \[e-pQLB (0.375% ropivacaine+100 mcg epinephrine) or pQLB (0.375% ropivacaine)\] and the investigators evaluated if the adjunct of epinephrine to ropivacaine increases of efficacy (measured as opioid consumption during the first 24 postoperative hours, time for first request of opioid and pain values reported by patients) and the safety (measured as peak and plasmatic concentration of ropivacaine) of pQLB.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* first singleton pregnancy at term
* American Society of Anesthesiologists (ASA) physical status II;
* caesarean section under Spinal Anesthesia
Exclusion Criteria:
* patients enable to comprehend or use the verbal rating pain scoring system or patient controlled analgesia (PCA) pump;
* congenital coagulopathy;
* anatomical abnormalities;
* localized infections;
* use of drugs interfering with ropivacaine metabolism.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Postoperative pain
Timeframe: at 6, 12 and 24 hours after the end of surgery
2
Postoperative analgesic requirement
Timeframe: First 24 hours after the end of surgery