NCT02142829

Brief Summary

This study was conducted to compare the effectiveness of two local pain control methods in bariatric patients by assessing the amount of postoperative pain and amount of postoperative pain medications needed. This information was used to determine which local anesthetic provided the best pain control.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for phase_4 obesity

Timeline
Completed

Started Nov 2012

Shorter than P25 for phase_4 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 16, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 20, 2014

Completed
Last Updated

May 22, 2014

Status Verified

May 1, 2014

Enrollment Period

4 months

First QC Date

May 16, 2014

Last Update Submit

May 20, 2014

Conditions

Obesity

Keywords

bariatric surgery, postoperative pain

Outcome Measures

Primary Outcomes (1)

  • Numeric rating scale (NRS) pain intensity scores

    The NRS was from 0 = no pain and 10 = worst pain.

    4-6 hours postoperatively and in the mornings of postoperative Day 1 and Day 2

Secondary Outcomes (1)

  • Postoperative opioid consumption

    1 week

Study Arms (2)

EXPAREL

ACTIVE COMPARATOR

EXPAREL (bupivacaine liposome injectable suspension)

Drug: EXPAREL

On-Q Pain Ball

ACTIVE COMPARATOR

Device for delivering bupivacaine.

Drug: On-Q Pain Ball

Interventions

EXPARELDRUG
Also known as: bupivacaine liposome injectable suspension
EXPAREL
On-Q Pain BallDRUG

bupivacaine HCl 0.25%

Also known as: bupivacaine
On-Q Pain Ball

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-80, male or female

You may not qualify if:

  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bariatric Medical Institute of Texas

San Antonio, Texas, 78240, United States

Location

MeSH Terms

Conditions

ObesityPain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesPainNeurologic Manifestations

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Franchell Richard-Hamilton, MD

    Bariatric Medical Institute of Texas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2014

First Posted

May 20, 2014

Study Start

November 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

May 22, 2014

Record last verified: 2014-05

Locations

US(1)