Pain Control in Bariatric Patients: EXPAREL(R) vs. the On-Q(R) Pain Ball

NCT ID: NCT02142829

Last Updated: 2014-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-03-31

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.

Detailed Description

The investigators have previously utilized the On-Q® pain ball to obtain local control by continuous delivery of bupivacaine to pain fibers at the incision site. On-Q makes use of an implanted catheter and a continuous infusion pump that the patient carries with them typically for 48-72 hours after surgery. EXPAREL is a long-acting liposomal delivery vehicle that extends the life of bupivacaine in the surgical site for up to 72 hours. It can be injected in all trocar sites and offers another potential solution to patient pain control without the need for a catheter and the hardware needed to deliver the local anesthetic. Patient NRS (numerical rating scale) scores for postoperative pain and total medication consumed were used to assess the differences between the two treatment groups.

Conditions

Obesity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EXPAREL

EXPAREL (bupivacaine liposome injectable suspension)

Group Type: ACTIVE_COMPARATOR

EXPAREL

Intervention Type: DRUG

On-Q Pain Ball

Device for delivering bupivacaine.

Group Type: ACTIVE_COMPARATOR

On-Q Pain Ball

Intervention Type: DRUG

bupivacaine HCl 0.25%

Interventions

EXPAREL

Intervention Type: DRUG

On-Q Pain Ball

bupivacaine HCl 0.25%

Intervention Type: DRUG

Other Intervention Names

bupivacaine liposome injectable suspension; bupivacaine

Eligibility Criteria

Inclusion Criteria

• Age 18-80, male or female

Exclusion Criteria

• Pregnant women

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pacira Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Franchell Richard-Hamilton, MD

Role: PRINCIPAL_INVESTIGATOR

Bariatric Medical Institute of Texas

Locations

Bariatric Medical Institute of Texas

San Antonio, Texas, United States

Countries

United States