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Nerve Block for Regional Analgesia Supplements Pain Management Toolkits

April 10, 2018
Use of bupivacaine liposome injectable suspension in upper extremity surgeries provides an extended-duration, nonopioid anesthetic alternative

with Jay Joshi, MD

FDA has expanded the indication of bupivacaine liposome injectable suspension (Exparel, Pacira Pharmaceuticals) to include postsurgical regional analgesia through interscalene brachial plexus block. The supplemental NDA makes the non-opioid medication the first long-acting, single-dose nerve block available for patients undergoing upper extremity surgeries, such as total shoulder arthroplasty or rotator cuff repair, according to a Pacira news release

Growth in Nerve Block Usage 

“Brachial plexus blocks are emerging as a mainstay of postsurgical pain control for upper extremity procedures, and are well positioned to comprise more than 60 percent of all regional nerve block procedures within the next two years,” said Dave Stack, chairman and chief executive officer at Pacira, in the release.

Exparel was originally approved in 2011 for single-dose infiltration into the surgical site, and its expanded use may eliminate the need for catheters and pumps traditionally used to extend the duration of regional analgesia. The supplemental NDA approval was based on statistically significant data from a Phase 3 study in brachial plexus block for shoulder surgeries, in which the primary endpoint of cumulative pain scores over 48 hours was measured by the area under the curve (P < 0.0001). Secondary endpoints were also achieved: total postsurgical opioid consumption through 48 hours (P < 0.0001); opioid-free subjects through 48 hours (P < 0.01); and time to first opioid use through 48 hours (P < 0.0001), according to the release. 

What the Expanded Indication Means

“Anesthesiologists now have a slow release local anesthetic option to help in surgical cases involving the upper extremity,” said Jay Joshi, MD, CEO and Medical Director of the National Pain Centers, and an editorial advisory board member of Practical Pain Management. “This is a useful alternative for anesthesiologists who would have used regular release bupivacaine and for anesthesiologists who would have opted for indwelling catheters, that pose their own unique risks.”

However, Dr. Joshi added that the medical community is still “faced with the challenge of changing old physician habits. Post-operative education for staff, such as nurses, is still an issue. Despite this FDA approval, obtaining administrator and Pharmacy and Therapeutics committee approval to include Exparel on formulary is not a guaranteed outcome.” Read more about Dr. Joshi’s case for slow-release anesthetics

 

Last updated on: April 10, 2018
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