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

Phase 4

Completed

• Conditions: Obesity
• Interventions: Drug: EXPAREL; Drug: On-Q Pain Ball

• Registration Number: NCT02142829
• Lead Sponsor: Pacira Pharmaceuticals, Inc

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.

Study Timeline

• Study Start: 2012-11
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2014-05
• Study First Submitted: 2014-05-16
• Study First Submitted QC: 2014-05-19
• Study First Posted: 2014-05-20
• Last Update Submitted: 2014-05-20
• Last Update Posted: 2014-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

• Age 18-80, male or female

Exclusion Criteria

• Pregnant women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EXPAREL	EXPAREL	EXPAREL (bupivacaine liposome injectable suspension)
On-Q Pain Ball	On-Q Pain Ball	Device for delivering bupivacaine.

Primary Outcome Measures

Name	Time	Method
Numeric rating scale (NRS) pain intensity scores	4-6 hours postoperatively and in the mornings of postoperative Day 1 and Day 2	The NRS was from 0 = no pain and 10 = worst pain.

Secondary Outcome Measures

Name	Time	Method
Postoperative opioid consumption	1 week

Trial Locations

Locations (1)

Bariatric Medical Institute of Texas; 🇺🇸 San Antonio, Texas, United States