Bupivacaine Levels in Liver Resection Patients

NCT03145805 | Completed

• 1 other identifier: ANAE-300-16
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Bupivacaine is a local anesthetic commonly used to manage postoperative pain. Liver resection patients typically have an epidural catheter placed preoperatively through which they receive a continuous infusion of bupivacaine and hydromorphone for up to 5 days postoperatively. The liver metabolizes bupivacaine, and produces proteins that bind with bupivacaine to take it out of circulation and thereby reduce its toxicity. Because a portion of the liver is being removed due to pre-existing liver disease, investigators hypothesize that liver resection patients have an impaired ability to clear bupivacaine from circulation that may increase their susceptibility to bupivacaine toxicity. To assess this, investigators will measure free and bound bupivacaine in liver resection patients postoperatively to determine whether bupivacaine reaches toxic levels. Investigators will also quantify binding protein levels to determine if these levels are reduced after surgery, which could contribute to the elevated bupivacaine levels in these patients. Finally, investigators will monitor patients for signs and symptoms associated with bupivacaine toxicity.

Conditions

Hepatectomy; Analgesia, Epidural

Keywords

blood chemical analysis; bupivacaine; local anesthetic toxicity; Drug-Related Side Effects and Adverse Reactions

Outcome Measures

Primary Outcomes (10)

• bound bupivacaine levels-1

  plasma bound bupivacaine levels in liver resection patients upon entry to the post anesthesia care unit

  1-2 hours following surgery

• bound bupivacaine levels-2

  plasma bound bupivacaine levels on postoperative day 2.

  48 hours following surgery

• bound bupivacaine levels-3

  plasma bound bupivacaine levels upon discontinuation of bupivacaine infusion (3-5 days postoperatively)

  72-120 hours following surgery

• unbound bupivacaine levels-4

  plasma unbound bupivacaine levels in liver resection patients upon entry to the post anesthesia care unit

  1-2 hours following surgery

• unbound bupivacaine levels-5

  plasma unbound bupivacaine levels on postoperative day 2.

  48 hours following surgery

• unbound bupivacaine levels-6

  plasma unbound bupivacaine levels upon discontinuation of bupivacaine infusion

  72-120 hours following surgery

• alpha-1-acid glycoprotein levels-(AGP)-1

  plasma AGP levels preoperatively

  1 hour preoperatively

• alpha-1-acid glycoprotein levels-(AGP)-2

  plasma AGP levels postoperatively upon entry to the post anesthesia care unit

  1-2 hours postoperatively

• alpha-1-acid glycoprotein levels-(AGP)-3

  plasma AGP levels on postoperative day 2

  48 hours postoperatively

• alpha-1-acid glycoprotein levels-(AGP)-4

  plasma AGP levels upon discontinuation of the bupivacaine infusion 3-5 days postoperatively

  72-120 hours postoperatively

Secondary Outcomes (8)

• signs/symptoms of local anesthetic toxicity-1

  1 hour preoperatively

• signs/symptoms of local anesthetic toxicity-2

  1-2 hours postoperatively

• signs/symptoms of local anesthetic toxicity-3

  48 hours postoperatively

• signs/symptoms of local anesthetic toxicity-4

  72-120 hours postoperatively

• surgical site pain-1

  1 hour preoperatively

Study Arms (1)

liver resection patients

Liver resection patients sited with an epidural catheter for bupivacaine infusion for 3-5 days postoperatively to manage postoperative pain

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Twenty patients over 18 years of age scheduled to undergo elective liver resection surgery and placement of an epidural catheter for continuous bupivacaine infusion to manage pain for 3-5 days postoperatively.

You may qualify if:

• scheduled to undergo elective liver resection surgery
• indicated to be sited with an epidural catheter for bupivacaine infusion for the management of postoperative pain
• competent to provide informed consent
• American anesthesiologists physical classification of I-IV

You may not qualify if:

• pregnant
• renal failure requiring dialysis
• sepsis
• ejection fraction documented as \<15%
• taking fluvoxamine or itraconazole
• unable to understand or read English

Sponsors & Collaborators

• Jessica Burjorjee, MD, FRCPC: lead

Study Sites (1)

Kingston General Hospital

Kingston, Ontario, K7L2V7, Canada

Location

Related Publications (1)

• Burjorjee J, Phelan R, Hopman WM, Ho AM, Nanji S, Jalink D, Mizubuti GB. Plasma bupivacaine levels (total and free/unbound) during epidural infusion in liver resection patients: a prospective, observational study. Reg Anesth Pain Med. 2022 Aug 24:rapm-2022-103683. doi: 10.1136/rapm-2022-103683. Online ahead of print.

  PMID: 36002226 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Diagnostic 4 ml blood samples will be drawn from 20 liver resection patients sited with an epidural catheter for 3-5 days of bupivacaine infusion to manage their postoperative pain. Blood will be drawn by phlebotomy with standard of care blood blood-work at 4 time points: preoperatively, upon entry to the post-anesthesia care unit, 2 days postoperatively and then immediately before discontinuation bupivacaine infusion. Blood will be immediately centrifuged by the hospital laboratory and plasma divided into 2 aliquots to be stored at -70 until all samples are collected- at which point they will be shipped to collaborators for analysis of AGP as well as bound and unbound bupivacaine.

MeSH Terms

Conditions

Agnosia; Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Chemically-Induced Disorders

Study Officials

• Jessica Burjorjee, MD, FRCPC

  Queen's University/Kingston General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: May 9, 2017
• Study Start: June 19, 2017
• Primary Completion: February 15, 2020
• Study Completion: February 15, 2020
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)