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Outcome Measures

Primary Outcomes (1)

Changed pain scores using liposomal bupivacaine day 1 post-operative
Using the 10 point pain scale, determine if liposomal bupivacaine use leads to changed pain scores on post-operative day 1 compared to standard analgesics after laparoscopic sleeve gastrectomy.
Day 1 post-operative

Secondary Outcomes (2)

Changed pain scores liposomal bupivacaine days 0, 2,3 post-operative
Days 0, 2, 3 post-operative
Changed use of opioid medications post operative days 0-3
Post-operative days 0-3

Study Arms (2)

Experiemental

EXPERIMENTAL

Subjects will be treated with liposomal bupivacaine (study drug) after undergoing bariatric surgery.

Drug: Treatment with liposomal bupivacaine

Standard of Care

ACTIVE COMPARATOR

Subjects will be treated with standard bupivacaine after undergoing bariatric surgery.

Drug: Treatment with standard bupivacaine

Interventions

Treatment with liposomal bupivacaineDrug

Patients will randomly be treated with either liposomal bupivacaine (study drug) after undergoing bariatric surgery.

Also known as: Exparel

Experiemental

Treatment with standard bupivacaineDrug

Patients will randomly be treated with standard bupivacaine after undergoing bariatric surgery.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product

Treatment with liposomal bupivacaine

The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.

View registry record

Eligibility Criteria

Age13 Years - 18 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

patients who are undergoing a laparoscopic sleeve gastrectomy for severe obesity who are between 13 and 2018 years of age.
Only patients treated at the Children's Hospital of Richmond at VCU will be included.

Study Design

Study Type

interventional

Phase

phase 1

Allocation

RANDOMIZED

Masking

SINGLE

Who Masked

PARTICIPANT

Masking Details

Patients will not be told the group to which they were assigned and will have been under anesthesia for administration. The surgeon, other clinical team members, and the study staff will not be blinded to the study group assignment.

Purpose

TREATMENT

Intervention Model

PARALLEL

Model Details: Patients will randomly be treated with either liposomal bupivacaine (study drug) or standard bupivacaine after undergoing bariatric surgery.

Sponsor Type

OTHER

Responsible Party

SPONSOR

Liposomal Bupivacaine for Post-operative Pain Control in Adolescent Bariatric Patients

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Experiemental

Standard of Care

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Experiemental

Standard of Care

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations