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

Pacira

Status and phase: Completed; Phase 4

Conditions: Obesity

Treatments: Drug: On-Q Pain Ball; Drug: EXPAREL

Study type: Interventional

Funder types: Industry

Identifier

NCT02142829

Details and patient eligibility

About

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.

Full 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.

Enrollment: 101 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-80, male or female

Exclusion criteria

• Pregnant women

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 2 patient groups

EXPAREL

Active Comparator group

Description:

EXPAREL (bupivacaine liposome injectable suspension)

Treatment:

Drug: EXPAREL

On-Q Pain Ball

Active Comparator group

Description:

Device for delivering bupivacaine.

Treatment:

Drug: On-Q Pain Ball