Ropivacaine Use Intraincisionally Versus Intraperitoneally for Post-Laparoscopic Cholecystectomy … (NCT03265223) | Clinical Trial Compass
CompletedPhase 4
Ropivacaine Use Intraincisionally Versus Intraperitoneally for Post-Laparoscopic Cholecystectomy Pain
353 participantsStarted 2014-04-01
Plain-language summary
Pain still remains a limiting factor in early discharge of patients undergoing laparoscopic cholecystectomy. Almost all earlier studies done to compare the efficacy of local anaesthetics used intraperitoneally as compared to intraincisionally used equal amounts of drugs at the two locations, usually 10-20 ml. Using this large amount of drug in the small space of intraincisional location as compared to similar amount of drug in large intraperitoneal space created an inadvertent bias in favor of patients receiving the drug intraincisionally so such patients naturally experienced less pain. The investigators decided to standardize the drug used at these two locations as 1ml/cm and conduct a new study comparing the effects of drugs in relieving pain when used at these two locations.
Who can participate
Age range
15 Years – 80 Years
Sex
ALL
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:
* All patients in the age group of 15-80 years
* Patients conferring to Grade I or II of American Society of Anesthesiologists (ASA) physical status classification system only
* Patients undergoing elective Laparoscopic Cholecystectomy
* Patients having symptomatic cholelithiasis only
* Patients operated by a single surgeon were included.
Exclusion Criteria:
* Patients with known allergic reactions to local anesthetics
* Cases that were converted to open cholecystectomy
* Patients with major intra-operative complications
* Patients suffering from acute cholecystitis, empyema or malignancy of gall bladder, having history of chronic pain or those taking frequent analgesics or opioids pre-operatively
* Patients with peptic ulceration, bleeding disorders, impaired renal and/or hepatic function, and sensitivity to NSAIDs or opioids.
* Patients in whom gall bladder (GB) stones are found incidentally on ultrasonography (USG) (asymptomatic cholelithiasis)
* Patients suffering from severe chronic medical diseases and morbid obesity
* Patients unable to comprehend instructions or having communication problems were excluded from the study.
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
Effect of ropivacaine use intraincisionally versus intraperitoneally as compared to controls on post-laparoscopic cholecystectomy pain