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 range18 Years

SexALL

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,…

What they're measuring

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

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

Cumulative 72-hour opioid consumption (OC_0-72h)

Timeframe: Intraoperatively and during the first 72 hours postoperatively or until hospital discharge, whichever occurs earlier

Trial details

NCT IDNCT03715517

SponsorUniversity of Manitoba

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2031-07-31

Contact for this trial

Alex Grunfeld, MD

204-787-1125 alexander.grunfeld@umanitoba.ca

View on ClinicalTrials.gov More Hepatectomy trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

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

Cumulative 72-hour opioid consumption (OC_0-72h)

Timeframe: Intraoperatively and during the first 72 hours postoperatively or until hospital discharge, whichever occurs earlier