Liposomal Bupivacaine in Bariatric Surgery

October 15, 2019 updated by: Diego Camacho, Montefiore Medical Center

Randomized Controlled Trial Investigating Use of Liposomal Bupivacaine in Bariatric Surgery

The aim of this study is to perform a randomized controlled trial for patients undergoing bariatric surgery, comparing the need for opiates with and without administration of a transversus abdominis plane (TAP) block using the long acting local anesthetic, liposomal bupivacaine (Exparel®). From this study, the investigators will assess whether use of long acting local anesthetic can reduce the need for opiates in the bariatric population.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A prospective randomized controlled trial investigating the use of long acting local anesthetic for transversus abdominis block in patients undergoing bariatric surgery at Montefiore Medical Center. Patients will be randomized to either receive an intraoperative TAP block with LB, an intraoperative TAP block with RB, or no TAP block. All participants will receive standard post-operative analgesia regimen. Pain scores will be recorded by the nursing staff as reported by the patients for 24-36 hours post surgery. Patients will be monitored for secondary post-operative complications up to the 2-week mark following intervention.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
219

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Obese patients undergoing bariatric surgery (LSG or LRYGB)
  • Patients 18 years of age and older
  • Surgical treatment between 01/01/2018 and 12/31/2018 over a 1 year period

Exclusion Criteria:

  • Patients under the age of 18 years old
  • Patients taking any opiates within 30 days of enrollment in the trial
  • Patients with a history of chronic pain.
  • Patients taking pregabalin or gabapentin.
  • ASA IV
  • Prior laparotomy
  • Body Mass Index ≥ 60 kg/m2
  • History of cardiac arrhythmia
  • History of Seizure
  • Psychiatric Diagnosis currently on antipsychotic medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Liposomal Bupivacaine TAP block
Patients will be randomized to receive an intraoperative transverse abdominis peritoneal (TAP) block with liposomal bupivacaine (LB). The solution used to perform the TAP block with LB will comprise of 20mL of liposomal bupivacaine solution, 30mL of 0.25% bupivacaine, and 100mL of normal saline.
Drug: Liposomal Bupivacaine TAP block
Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization.
Other Names:
  • Exparel TAP block
Active Comparator: Regular Bupivacaine TAP block
Patients will be randomized to receive an intraoperative transverse abdominis peritoneal (TAP) block with regular bupivacaine (RB).The solution used to perform the TAP block with RB will comprise of 50mL of 0.25% bupivacaine and 100mL of normal saline.
Drug: Bupivacaine TAP block
Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization.
No Intervention: No TAP block
Patients will be randomized to receive no TAP block as a control group.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fentanyl PCA mcg
Time Frame: 24 hours post surgery.
Fentanyl PCA (patient controlled analgesia) total microgram usage.
24 hours post surgery.
Total Fentanyl Usage
Time Frame: During hospitalization, up to 7 days.
Total fentanyl usage in micrograms, including both PCA and IV push administered medication.
During hospitalization, up to 7 days.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Acetaminophen Usage
Time Frame: During hospitalization, up t 7 days.
Total amount of acetaminophen used for analgesia.
During hospitalization, up t 7 days.
NSAID Usage
Time Frame: During hospitalization, up to 7 days.
Total amount of NSAID (ketorolac) use for analgesia.
During hospitalization, up to 7 days.
Pain Score
Time Frame: 24 hours post surgery.
Patient reported composite measure pain score, with a total range of 0 to 10, with 0 being the absence of pain, 1 being the least amount of pain and 10 being the highest amount of pain.
24 hours post surgery.
Length of Stay
Time Frame: Assessed every 24 hours post surgery, up to 168 hour post-surgery.
Hours of hospitalization post-surgery
Assessed every 24 hours post surgery, up to 168 hour post-surgery.
Nausea
Time Frame: 24 hours post surgery.
Number of participants with presence or absence of nausea reported and recorded by the nurse.
24 hours post surgery.
Time to Ambulation
Time Frame: Assessed every 24 hours post surgery, up to 168 hour post-surgery.
Assessed every 24 hours post surgery, up to 168 hour post-surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Montefiore Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 30, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 9, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 14, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 4, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017-7706

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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