Clinical trial NCT02875288: Trial of Liposomal Versus Plain Bupivacaine in Minimally Invasive General Surgery Procedures
Official title: Prospective Randomized Trial of Liposomal Versus Plain Bupivacaine in Minimally Invasive General Surgery Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: United States Naval Medical Center, San Diego
Sponsor class: FED
First posted: 2016-08-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age: 18 years or older
* American Society of Anesthesiologists (ASA) status 1, 2 or 3
* Having an elective, minimally invasive, general surgery procedure at Naval Medical Center San Diego (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

Primary outcomes:
measure: Total post operative narcotic use in morphine equivalents.
timeFrame: Up to fourteen days.
Secondary outcomes:
measure: Length of hospital stay post operative procedure.
timeFrame: up to fourteen days.
measure: Pain level pre and post operative procedure.
timeFrame: Up to fourteen days.
measure: Post operative procedure physical functioning level.
timeFrame: Up to fourteen days.
measure: Number of post operative procedure adverse events.
timeFrame: Up to fourteen days.
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
Study officials:
affiliation: United States Naval Medical Center, San Diego
name: David P Gallus, MD
role: PRINCIPAL_INVESTIGATOR
References: