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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02875288
• Other study ID #: NMCSD.2015.0067
• Status: Recruiting
• Phase: N/A
• First received: August 18, 2016
• Last updated: March 7, 2017
• Start date: December 2015
• Est. completion date: November 2018

Study information

• Verified date: March 2017
• Source: United States Naval Medical Center, San Diego
• Contact: David P Gallus, MD
• Phone: 6195327575
• Email: david.p.gallus.mil[@]mail.mil
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• liposomal bupivicaine
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

Locations

Country	Name	City	State
United States	Naval Medical Center San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
United States Naval Medical Center, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post Operative Narcotic Use in Morphine Equivalents	Determine if there is decreased post operative narcotic pain medication needs after use of liposomal bupivicaine	2 weeks