Spinal Anesthesia for Enhanced Recovery After Liver Surgery

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
University of Manitoba
RECRUITING
Winnipeg
Contact Information
Primary
Alex Grunfeld, MD
alexander.grunfeld@umanitoba.ca
204-787-1125
Time Frame
Start Date: 2018-10-04
Estimated Completion Date: 2026-01
Participants
Target number of participants: 128
Treatments
Experimental: Intrathecal morphine
Spinal anesthesia with intrathecal morphine~Bolus (pre-induction): High-spinal anesthesia with 0.25 mg⋅kg-¹ hyperbaric bupivacaine 0.75% plus 3 mcg⋅kg-¹ intrathecal morphine (preservative-free)~Postoperative analgesia: IV-PCA hydromorphone (bolus: 0.2 mg \[range: 0.1-0.4 mg\]; 5 min lockout; no infusion)
Active_comparator: Thoracic epidural analgesia
Continuous thoracic epidural analgesia~Bolus (pre-induction): 0.25 mg⋅kg-¹ bupivacaine 0.25% plus 1 mcg⋅kg-¹ hydromorphone (0.1 mL⋅kg-¹)~Infusion (initial): 0.25 mg⋅kg-¹⋅h-¹ bupivacaine 0.25% plus 1 mcg⋅kg-¹⋅h-¹ hydromorphone (0.1 mL⋅kg-¹⋅h-¹)~Infusion (range): 0.19-0. 3 mg⋅kg-¹⋅h-¹ bupivacaine 0.25% plus 0.75-1.25 mcg⋅kg-¹⋅h-¹ hydromorphone (0.075-0.125 mL⋅kg-¹⋅h-¹) (3-10 mL⋅h-¹)~Postoperative analgesia: (1) Epidural solution, bupivacaine 0.125% with hydromorphone 10 mcg·mL-¹, infusion range as above (0.075-0.125 mL⋅kg-¹⋅h-¹) (3-10 mL⋅h-¹), continued for a maximum of 72 h postoperatively; (2) IV-PCA hydromorphone (bolus: 0.2 mg \[range: 0.1-0.4 mg\]; 5 min lockout; no infusion).
Sponsors
Leads: University of Manitoba

This content was sourced from clinicaltrials.gov