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

NCT02875288 | Completed

• 1 other identifier: NMCSD.2015.0067
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Total post operative narcotic use in morphine equivalents.

  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.

  Up to fourteen days.

Secondary Outcomes (4)

• Length of hospital stay post operative procedure.

  up to fourteen days.

• Pain level pre and post operative procedure.

  Up to fourteen days.

• Post operative procedure physical functioning level.

  Up to fourteen days.

• Number of post operative procedure adverse events.

  Up to fourteen days.

Study Arms (2)

Liposomal Bupivicaine arm

EXPERIMENTAL

Post procedure, infiltrate wounds with liposomal bupivacaine 1. Liposomal Bupivacaine (Brand name Exparel) 266 milligram (mg)/20 mL to be diluted to 30 mL with normal saline 2. 10 mL of study drug to be injected at each 10-12 millimeter (mm) trocar site and 5 mL of study drug to be injected at the 5 mm trocar sites. Typically there are two 10 mm trocar sites and three 5 mm trocar sites.

Drug: liposomal bupivicaine

Plain Bupivicaine

ACTIVE COMPARATOR

1. Post procedure, infiltrate wounds with plain bupivicaine 2. Plain Bupivacaine 0.25%, volume of 30 mL 3. 10 mL of study drug to be injected at each 10-12 millimeter (mm) trocar site and 5 mL of study drug to be injected at the 5 mm trocar sites. Typically there are two 10 mm trocar sites and three 5 mm trocar sites.

Drug: liposomal bupivicaine

Interventions

liposomal bupivicaine DRUG

1. 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. 2. The treatment procedures or regimens; The treatment procedure is direct, surgical site infiltration with either liposomal or plain bupivacaine. 3. 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 4. Route of drug administration; Surgical site infiltration

Also known as: Exparel

Liposomal Bupivicaine arm; Plain Bupivicaine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• United States Naval Medical Center, San Diego: lead

Study Sites (1)

Naval Medical Center San Diego

San Diego, California, 92134, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• David P Gallus, MD

  United States Naval Medical Center, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2016
• First Posted: August 23, 2016
• Study Start: December 1, 2015
• Primary Completion: January 6, 2020
• Study Completion: January 6, 2020
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)