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Completed

NCT Number: NCT02142829

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

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.

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Key information

Conditions

Obesity Body Weight Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bariatric Medical Institute of Texas

San Antonio, Texas, 78240, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-80, male or female

Exclusion criteria

  • Pregnant women

Treatment and study plan

Exparel

Drug

Other names: bupivacaine liposome injectable suspension

On-Q Pain Ball

Drug

bupivacaine HCl 0.25%

Other names: bupivacaine

Primary outcomes

  1. Numeric rating scale (NRS) pain intensity scores

    Time frame: 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 outcomes

  1. Postoperative opioid consumption

    Time frame: 1 week

Sponsors and collaborators

Lead sponsor

Pacira Pharmaceuticals, Inc

Industry

Registry information

Official study title

Pain Control in Bariatric Patients: A Prospective Trial Comparing the Effectiveness of EXPAREL(R) Versus the On-Q(R) Pain Ball

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 20, 2014
Registry last updated
May 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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