Trial of Liposomal Versus Plain Bupivacaine in Minimally Invasive General Surgery Procedures



Status:Recruiting
Conditions:Post-Surgical Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - 65
Updated:3/9/2017
Start Date:December 2015
End Date:November 2018
Contact:David P Gallus, MD
Email:david.p.gallus.mil@mail.mil
Phone:6195327575

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Prospective Randomized Trial of Liposomal Versus Plain Bupivacaine in Minimally Invasive General Surgery Procedures

Aim: To compare the postoperative outcomes after surgical infiltration with plain
bupivacaine compared to liposomal bupivacaine in patients undergoing elective, minimally
invasive, general surgery procedures. To the investigators knowledge, there are no
head-to-head, prospective, randomized, controlled trials of plain bupivacaine versus
liposomal bupivacaine to evaluate postoperative pain and return of function.

The investigators current standard has been to use liposomal bupivacaine routinely for
surgical infiltration which was a change from the historical practice of infiltration with
lidocaine/bupivacaine, plain bupivacaine or no local anesthetic at all. The change was made
due to the perceived benefits in analgesia past the 12-24 hours that plain bupivacaine was
effective. It is not clear, however, that there are statistically significant benefits in
terms of reduced narcotic use and length of hospital stay and improved pain control and
return of function post-operatively.

Primary outcomes: The investigators will then measure narcotic use post-operatively as
calculated by combining measures of patient-controlled analgesia (PCA) use for first 24
hours added to in-patient oral narcotic use (by referencing the electronic medical record
(EMR)) as well as out-patient oral narcotic use as reported by patients. Subjective pain
levels and pain interference scale and physical functioning scale will be evaluated
pre-operatively and post-operatively with use of the Pain Assessment Screening Tool and
Outcomes Registry (PASTOR) developed by the Defense and Veterans Center for Integrative Pain
Management (DVCIPM) as a measure of perioperative pain and function.

Inclusion Criteria:

- Age: 18 years or older

- ASA status 1, 2 or 3

- Having an elective, minimally invasive, general surgery procedure at NMCSD

Exclusion Criteria:

- Age: Younger than 18 years old

- Pregnant women - safety of liposomal bupivacaine has not been studied in pregnant
women

- ASA status greater than or equal to 4

- Conversion to open procedure/laparotomy

- History of reaction to local anesthetics

- History of hepatic disease - local anesthetics are metabolized in the liver

- History of pre-operative/concurrent condition requiring narcotic use

- Patient not able to adhere to post-operative pain control regimen outlined in methods
section
We found this trial at
1
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34800 Bob Wilson Dr,
San Diego, California 92134
(619) 532-6400
Phone: 619-532-7575
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