Spinal Anesthesia For Enhanced Recovery After Liver Surgery (NCT03715517) | Clinical Trial Compass
RecruitingNot Applicable
Spinal Anesthesia For Enhanced Recovery After Liver Surgery
Canada128 participantsStarted 2018-10-04
Plain-language summary
This project proposes to compare epidural versus spinal anesthesia in patients having liver resection surgery. The investigators hypothesize that spinal anesthesia will result in improved blood pressure control postoperatively and reduce the amount of intravenous fluids required after surgery. Spinal anesthesia is expected to provide the same pain control benefits as epidurals, with faster recovery of function. Spinal anesthesia may be a simple and effective way to improve and enhance the recovery in the increasing number of patients requiring liver resection.
Who can participate
Age range
18 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:
* Male or female, Adults aged ≥ 18 years (there will be no upper age restriction);
* American Society of Anesthesiologists Physical Status classification (ASA-PS) of I to III;
* Undergoing subcostal or midline laparotomy for elective liver resection surgery under general anesthesia; if the planned procedure is a combined operation (i.e., concomitant extrahepatic surgery) , the associated procedure should not add more than one hour to the surgical time of the primary hepatic resection procedure alone;
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Provision of signed and dated informed consent form
* Body mass index (BMI) between 17 and 40 kg·m-², inclusive;
* Negative result on serum pregnancy test at Screening and negative urine pregnancy test at Baseline (for women of childbearing potential, defined as those who have not undergone a hysterectomy or been postmenopausal for at least 12 consecutive months); and not currently breastfeeding, or planning to do so within 7 d following surgery;
* Stated willingness and ability to comply with all study and/or follow-up evaluations and communicate clearly with the Investigator and staff; and
* Voluntary participation and ability to provide written informed consent prior to any study procedures.
Exclusion Criteria:
* Emergency surgery;
* Age \< 18 years;
* Planned laparoscopic hepatic resection;
* Planned laparotomy incision other than (right) subcostal,…
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
Cumulative 72-hour volume of intravenous fluids and blood products administered
Timeframe: Intraoperatively and during the first 72 hours postoperatively or until hospital discharge, whichever occurs earlier
2
Area under the curve over 72 hours of the summed pain intensity difference scores at rest (AUC-SPID-PAR_0-72h)
Timeframe: 72 hours after surgery or until hospital discharge, whichever occurs earlier
3
Cumulative 72-hour opioid consumption (OC_0-72h)
Timeframe: Intraoperatively and during the first 72 hours postoperatively or until hospital discharge, whichever occurs earlier