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

NCT ID: NCT02875288

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2020-01-06

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.

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Liposomal Bupivicaine arm

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.

Group Type: EXPERIMENTAL

liposomal bupivicaine

Intervention Type: 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

Plain Bupivicaine

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.

Group Type: ACTIVE_COMPARATOR

liposomal bupivicaine

Intervention Type: 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

Interventions

liposomal bupivicaine

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

Intervention Type: DRUG

Other Intervention Names

Exparel

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

United States Naval Medical Center, San Diego

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David P Gallus, MD

Role: PRINCIPAL_INVESTIGATOR

United States Naval Medical Center, San Diego

Locations

Naval Medical Center San Diego

San Diego, California, United States

Countries

United States

Other Identifiers

NMCSD.2015.0067

Identifier Type: -

Identifier Source: org_study_id