Skip to main content
OpenTrials
Completed

NCT Number: NCT02875288

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Naval Medical Center San Diego

San Diego, California, 92134, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Liposomal Bupivicaine

Drug
  • The intervention that is being tested and who will perform the procedures; Two general surgeons will perform the procedure with either liposomal or plain bupivacaine.
  • The treatment procedures or regimens; The treatment procedure is direct, surgical site infiltration with either liposomal or plain bupivacaine.
  • Dosage level and justification; Liposomal Bupivacaine: 266 mg/20 mL liposomal bupivacaine diluted to 30 mL Plain Bupivacaine: 30 mL of 0.5% plain bupivacaine
  • Route of drug administration; Surgical site infiltration

Other names: Exparel

Primary outcomes

  1. Total post operative narcotic use in morphine equivalents.

    Time frame: Up to fourteen days.

    To be measured by combining measures of Patient-Controlled Analgesia pump use for the first 24 hours added to in-patient oral narcotic use (by referencing the electronic medical record (EMR) and out-patient oral narcotic use as reported by patients.

Secondary outcomes

  1. Length of hospital stay post operative procedure.

    Time frame: up to fourteen days.

    Participants post operative procedure length of stay will be determined from the electronic medical record.

  2. Pain level pre and post operative procedure.

    Time frame: Up to fourteen days.

    Baseline pain level will be gathered pre operative procedure and post operative procedure day one, seven, and fourteen through the 0 to 10 pain scale with 0 being "No Pain", 5 being "Moderate Pain", and 10 being "Worse Possible Pain".

  3. Post operative procedure physical functioning level.

    Time frame: Up to fourteen days.

    Data is gathered on POP day one, seven and fourteen through the Physical Functioning Scale (PFS), which is scored from 0 to 100 with a higher scores indicating better physical function.

  4. Number of post operative procedure adverse events.

    Time frame: Up to fourteen days.

    Data is gathered from the patient electronic medical record (EMR).

Sponsors and collaborators

Lead sponsor

United States Naval Medical Center, San Diego

Fed

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Aug 23, 2016
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.