BridgeMD
New treatment option for Hepatectomy
Official title Spinal Anesthesia For Enhanced Recovery After Liver Surgery
ClinicalTrials.gov ID: NCT03715517
What this study is testing
What is Bupivacaine 0.75% in Dextrose Inj 8.25%?
Bupivacaine 0.75% in Dextrose Inj 8.25% is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hepatectomy.
Also referred to as Spinal heavy bupivacaine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Provision of signed and dated informed consent form
You likely can't join if
- Emergency surgery;
- Age \< 18 years;
- Planned laparoscopic hepatic resection;
- Planned laparotomy incision other than (right) subcostal, midline, or extended midline;
- Patients with obvious non-resectable disease prior to signing informed consent;
- Liver transplant recipient or previous hepatic resection or living-donor hepatectomy surgery;
See the full eligibility 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...
- 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...
- 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.
- Emergency surgery;
- Age \< 18 years;
- Planned laparoscopic hepatic resection;
- Planned laparotomy incision other than (right) subcostal, midline, or extended midline;
- Patients with obvious non-resectable disease prior to signing informed consent;
- Liver transplant recipient or previous hepatic resection or living-donor hepatectomy surgery;
- Major surgery (open abdominal and/or thoracic) under general anesthesia ≤ 30 d preoperatively;
- Contraindications to neuraxial (spinal or epidural) anesthesia: (a) anticipated difficult intubation; (b) coagulation or hemostatic abnormalities within 30 d of surgery (defined as thrombocytopenia [platelet count \...
- Significant cardiac arrhythmias (including pacemaker-dependence) or clinically significant cardiovascular disease (New York Heart Association [NYHA] functional classification III-IV);
- Volume overload (hyperhydration), particularly in cases of pulmonary edema or acute decompensated congestive heart failure (CHF);
- Acute kidney injury (AKI) and/or chronic kidney disease (CKD) based on the 2012 Kidney Disease Improving Global Outcomes (KDIGO) AKI (excluding the oliguria criterion) and CKD guideline definitions: AKI: increase in...
- Severe hypernatremia ([Na⁺] ≥ 155 mmol L-¹) and/or hyperchloremia ([Cl-] ≥ 125 mmol L-¹);
- Chronic pain; current (≤ 30 d preoperatively) and/or prior chronic (for a period of ≥ 90 d) opioid use; or history of alcohol, opiate, and/or other drug abuse or dependence;
- Use of supraphysiologic glucocorticoid (GC) doses (≥ 7.5 mg day-¹ of prednisone or equivalent): recent (≤ 30 d), prolonged (\> 2 consecutive weeks), or multiple courses totalling \> 3 weeks in the preceding 6 months;
- Known allergy or sensitivity (e.g., glucose-6-phosphate dehydrogenase [G6PD] deficiency) to amide local anesthetics, opioids, or acetaminophen, or hypersensitivity to other materials to be used in the study (e.g., latex...
- Altered mental status or educational, psychiatric, or communication (language, literacy) barriers that would impede accurate assessment of postoperative pain and/or ability to complete questionnaire instruments.
The study team makes the final eligibility decision.
Where it's taking place
- Winnipeg, Manitoba, Canada
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Winnipeg, Manitoba, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.