Liposomal Bupivacaine for Pain Control After Anterior Cruciate Ligament Reconstruction: A Prospective, Double-Blinded, Randomized, Positive-Controlled Trial
Background: Local anesthetics are commonly administered into surgical sites as a part of multimodal pain control regimens. Liposomal bupivacaine is a novel formulation of bupivacaine designed for slow diffusion of a single dose of local anesthetic over a 72-hour period. While early results are promi...
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| Veröffentlicht in: | The American journal of sports medicine 2016-07, Vol.44 (7), p.1680-1686 |
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| container_title | The American journal of sports medicine |
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| creator | Premkumar, Ajay Samady, Heather Slone, Harris Hash, Regina Karas, Spero Xerogeanes, John |
| description | Background:
Local anesthetics are commonly administered into surgical sites as a part of multimodal pain control regimens. Liposomal bupivacaine is a novel formulation of bupivacaine designed for slow diffusion of a single dose of local anesthetic over a 72-hour period. While early results are promising in various settings, no studies have compared pain management regimens containing liposomal bupivacaine to traditional regimens in patients undergoing anterior cruciate ligament (ACL) reconstruction.
Purpose:
To evaluate liposomal bupivacaine in comparison with 0.25% bupivacaine hydrochloride (HCl) for pain control after ACL reconstruction.
Study Design:
Randomized controlled trial; Level of evidence, 1.
Methods:
A total of 32 adult patients undergoing primary ACL reconstruction with a soft tissue quadriceps tendon autograft between July 2014 and March 2015 were enrolled. All patients received a femoral nerve block immediately before surgery. Patients then received either a 40-mL suspension of 20 mL Exparel (1 vial of bupivacaine liposome injectable suspension) and 20 mL 0.9% injectable saline or 20 mL 0.5% bupivacaine HCl and 20 mL 0.9% injectable saline, which was administered into the graft harvest site and portal sites during surgery. Patients were given either a postoperative smartphone application or paper-based journal to record data for 1 week after ACL reconstruction.
Results:
Of the 32 patients recruited, 29 patients were analyzed (90.6%). Two patients were lost to follow-up, and 1 was excluded because of a postoperative hematoma. There were no statistically significant differences in postoperative pain, medication use, pain location, recovery room time, or mobility between the 2 study groups.
Conclusion:
There were comparable outcomes with 0.25% bupivacaine HCl at a 200-fold lower cost than liposomal bupivacaine. This study does not support the widespread use of liposomal bupivacaine for pain control after ACL reconstruction in the setting of a femoral nerve block.
Registration:
ClinicalTrials.gov NCT02189317 |
| doi_str_mv | 10.1177/0363546516640772 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_1808727464</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sage_id>10.1177_0363546516640772</sage_id><sourcerecordid>1801429033</sourcerecordid><originalsourceid>FETCH-LOGICAL-c281t-2cacf43f4934a5ac9fa8bf9f0f5663c552412b2c715cb5445b0e738a410207703</originalsourceid><addsrcrecordid>eNqNkUtLxDAUhYMoOo7uXUnBjZtq3mmXY_EFBUXUbUljMmRom5q0gv_elBlFBgQ3Scj97rk5OQCcIHiBkBCXkHDCKGeIcwqFwDtghhjDKSGc7YLZVE6n-gE4DGEFIUSCZ_vgAAvEcpzDGXgtbe-Ca2WTXI29_ZBK2k4nxvnkMZ6SwnWDd02yMIP2yaKLq421wo_KykEnpV3KVndD8qSV68IQ7wfruiOwZ2QT9PFmn4OXm-vn4i4tH27vi0WZKpyhIcVKKkOJoTmhkkmVG5nVJjfQMM6JilYowjVW8bmqZpSyGmpBMkkRxNEvJHNwvtbtvXsfdRiq1galm0Z22o2hQhnMBBaU0_-giMY_ISSiZ1voyo2-i0YiRQRkAqGJgmtKeReC16bqvW2l_6wQrKZ4qu14YsvpRnisW_320_CdRwTSNRDkUv-a-pfgFxZklVw</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1837057113</pqid></control><display><type>article</type><title>Liposomal Bupivacaine for Pain Control After Anterior Cruciate Ligament Reconstruction: A Prospective, Double-Blinded, Randomized, Positive-Controlled Trial</title><source>MEDLINE</source><source>SAGE Complete</source><source>Alma/SFX Local Collection</source><creator>Premkumar, Ajay ; Samady, Heather ; Slone, Harris ; Hash, Regina ; Karas, Spero ; Xerogeanes, John</creator><creatorcontrib>Premkumar, Ajay ; Samady, Heather ; Slone, Harris ; Hash, Regina ; Karas, Spero ; Xerogeanes, John</creatorcontrib><description>Background:
Local anesthetics are commonly administered into surgical sites as a part of multimodal pain control regimens. Liposomal bupivacaine is a novel formulation of bupivacaine designed for slow diffusion of a single dose of local anesthetic over a 72-hour period. While early results are promising in various settings, no studies have compared pain management regimens containing liposomal bupivacaine to traditional regimens in patients undergoing anterior cruciate ligament (ACL) reconstruction.
Purpose:
To evaluate liposomal bupivacaine in comparison with 0.25% bupivacaine hydrochloride (HCl) for pain control after ACL reconstruction.
Study Design:
Randomized controlled trial; Level of evidence, 1.
Methods:
A total of 32 adult patients undergoing primary ACL reconstruction with a soft tissue quadriceps tendon autograft between July 2014 and March 2015 were enrolled. All patients received a femoral nerve block immediately before surgery. Patients then received either a 40-mL suspension of 20 mL Exparel (1 vial of bupivacaine liposome injectable suspension) and 20 mL 0.9% injectable saline or 20 mL 0.5% bupivacaine HCl and 20 mL 0.9% injectable saline, which was administered into the graft harvest site and portal sites during surgery. Patients were given either a postoperative smartphone application or paper-based journal to record data for 1 week after ACL reconstruction.
Results:
Of the 32 patients recruited, 29 patients were analyzed (90.6%). Two patients were lost to follow-up, and 1 was excluded because of a postoperative hematoma. There were no statistically significant differences in postoperative pain, medication use, pain location, recovery room time, or mobility between the 2 study groups.
Conclusion:
There were comparable outcomes with 0.25% bupivacaine HCl at a 200-fold lower cost than liposomal bupivacaine. This study does not support the widespread use of liposomal bupivacaine for pain control after ACL reconstruction in the setting of a femoral nerve block.
Registration:
ClinicalTrials.gov NCT02189317</description><identifier>ISSN: 0363-5465</identifier><identifier>EISSN: 1552-3365</identifier><identifier>DOI: 10.1177/0363546516640772</identifier><identifier>PMID: 27159290</identifier><identifier>CODEN: AJSMDO</identifier><language>eng</language><publisher>Los Angeles, CA: SAGE Publications</publisher><subject>Adult ; Anesthetics, Local - administration & dosage ; Anesthetics, Local - chemistry ; Anesthetics, Local - pharmacology ; Bupivacaine - administration & dosage ; Bupivacaine - chemistry ; Bupivacaine - pharmacology ; Double-Blind Method ; Female ; Humans ; Knee ; Liposomes ; Male ; Middle Aged ; Pain management ; Pain Management - methods ; Prospective Studies ; Skin & tissue grafts ; Sports medicine ; Surgical outcomes ; Young Adult</subject><ispartof>The American journal of sports medicine, 2016-07, Vol.44 (7), p.1680-1686</ispartof><rights>2016 The Author(s)</rights><rights>2016 The Author(s).</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c281t-2cacf43f4934a5ac9fa8bf9f0f5663c552412b2c715cb5445b0e738a410207703</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://journals.sagepub.com/doi/pdf/10.1177/0363546516640772$$EPDF$$P50$$Gsage$$H</linktopdf><linktohtml>$$Uhttps://journals.sagepub.com/doi/10.1177/0363546516640772$$EHTML$$P50$$Gsage$$H</linktohtml><link.rule.ids>314,777,781,21800,27905,27906,43602,43603</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27159290$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Premkumar, Ajay</creatorcontrib><creatorcontrib>Samady, Heather</creatorcontrib><creatorcontrib>Slone, Harris</creatorcontrib><creatorcontrib>Hash, Regina</creatorcontrib><creatorcontrib>Karas, Spero</creatorcontrib><creatorcontrib>Xerogeanes, John</creatorcontrib><title>Liposomal Bupivacaine for Pain Control After Anterior Cruciate Ligament Reconstruction: A Prospective, Double-Blinded, Randomized, Positive-Controlled Trial</title><title>The American journal of sports medicine</title><addtitle>Am J Sports Med</addtitle><description>Background:
Local anesthetics are commonly administered into surgical sites as a part of multimodal pain control regimens. Liposomal bupivacaine is a novel formulation of bupivacaine designed for slow diffusion of a single dose of local anesthetic over a 72-hour period. While early results are promising in various settings, no studies have compared pain management regimens containing liposomal bupivacaine to traditional regimens in patients undergoing anterior cruciate ligament (ACL) reconstruction.
Purpose:
To evaluate liposomal bupivacaine in comparison with 0.25% bupivacaine hydrochloride (HCl) for pain control after ACL reconstruction.
Study Design:
Randomized controlled trial; Level of evidence, 1.
Methods:
A total of 32 adult patients undergoing primary ACL reconstruction with a soft tissue quadriceps tendon autograft between July 2014 and March 2015 were enrolled. All patients received a femoral nerve block immediately before surgery. Patients then received either a 40-mL suspension of 20 mL Exparel (1 vial of bupivacaine liposome injectable suspension) and 20 mL 0.9% injectable saline or 20 mL 0.5% bupivacaine HCl and 20 mL 0.9% injectable saline, which was administered into the graft harvest site and portal sites during surgery. Patients were given either a postoperative smartphone application or paper-based journal to record data for 1 week after ACL reconstruction.
Results:
Of the 32 patients recruited, 29 patients were analyzed (90.6%). Two patients were lost to follow-up, and 1 was excluded because of a postoperative hematoma. There were no statistically significant differences in postoperative pain, medication use, pain location, recovery room time, or mobility between the 2 study groups.
Conclusion:
There were comparable outcomes with 0.25% bupivacaine HCl at a 200-fold lower cost than liposomal bupivacaine. This study does not support the widespread use of liposomal bupivacaine for pain control after ACL reconstruction in the setting of a femoral nerve block.
Registration:
ClinicalTrials.gov NCT02189317</description><subject>Adult</subject><subject>Anesthetics, Local - administration & dosage</subject><subject>Anesthetics, Local - chemistry</subject><subject>Anesthetics, Local - pharmacology</subject><subject>Bupivacaine - administration & dosage</subject><subject>Bupivacaine - chemistry</subject><subject>Bupivacaine - pharmacology</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Humans</subject><subject>Knee</subject><subject>Liposomes</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Pain management</subject><subject>Pain Management - methods</subject><subject>Prospective Studies</subject><subject>Skin & tissue grafts</subject><subject>Sports medicine</subject><subject>Surgical outcomes</subject><subject>Young Adult</subject><issn>0363-5465</issn><issn>1552-3365</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkUtLxDAUhYMoOo7uXUnBjZtq3mmXY_EFBUXUbUljMmRom5q0gv_elBlFBgQ3Scj97rk5OQCcIHiBkBCXkHDCKGeIcwqFwDtghhjDKSGc7YLZVE6n-gE4DGEFIUSCZ_vgAAvEcpzDGXgtbe-Ca2WTXI29_ZBK2k4nxvnkMZ6SwnWDd02yMIP2yaKLq421wo_KykEnpV3KVndD8qSV68IQ7wfruiOwZ2QT9PFmn4OXm-vn4i4tH27vi0WZKpyhIcVKKkOJoTmhkkmVG5nVJjfQMM6JilYowjVW8bmqZpSyGmpBMkkRxNEvJHNwvtbtvXsfdRiq1galm0Z22o2hQhnMBBaU0_-giMY_ISSiZ1voyo2-i0YiRQRkAqGJgmtKeReC16bqvW2l_6wQrKZ4qu14YsvpRnisW_320_CdRwTSNRDkUv-a-pfgFxZklVw</recordid><startdate>201607</startdate><enddate>201607</enddate><creator>Premkumar, Ajay</creator><creator>Samady, Heather</creator><creator>Slone, Harris</creator><creator>Hash, Regina</creator><creator>Karas, Spero</creator><creator>Xerogeanes, John</creator><general>SAGE Publications</general><general>Sage Publications Ltd</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7TS</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>U9A</scope><scope>7X8</scope></search><sort><creationdate>201607</creationdate><title>Liposomal Bupivacaine for Pain Control After Anterior Cruciate Ligament Reconstruction</title><author>Premkumar, Ajay ; Samady, Heather ; Slone, Harris ; Hash, Regina ; Karas, Spero ; Xerogeanes, John</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c281t-2cacf43f4934a5ac9fa8bf9f0f5663c552412b2c715cb5445b0e738a410207703</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Adult</topic><topic>Anesthetics, Local - administration & dosage</topic><topic>Anesthetics, Local - chemistry</topic><topic>Anesthetics, Local - pharmacology</topic><topic>Bupivacaine - administration & dosage</topic><topic>Bupivacaine - chemistry</topic><topic>Bupivacaine - pharmacology</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Humans</topic><topic>Knee</topic><topic>Liposomes</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Pain management</topic><topic>Pain Management - methods</topic><topic>Prospective Studies</topic><topic>Skin & tissue grafts</topic><topic>Sports medicine</topic><topic>Surgical outcomes</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Premkumar, Ajay</creatorcontrib><creatorcontrib>Samady, Heather</creatorcontrib><creatorcontrib>Slone, Harris</creatorcontrib><creatorcontrib>Hash, Regina</creatorcontrib><creatorcontrib>Karas, Spero</creatorcontrib><creatorcontrib>Xerogeanes, John</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Physical Education Index</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>MEDLINE - Academic</collection><jtitle>The American journal of sports medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Premkumar, Ajay</au><au>Samady, Heather</au><au>Slone, Harris</au><au>Hash, Regina</au><au>Karas, Spero</au><au>Xerogeanes, John</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Liposomal Bupivacaine for Pain Control After Anterior Cruciate Ligament Reconstruction: A Prospective, Double-Blinded, Randomized, Positive-Controlled Trial</atitle><jtitle>The American journal of sports medicine</jtitle><addtitle>Am J Sports Med</addtitle><date>2016-07</date><risdate>2016</risdate><volume>44</volume><issue>7</issue><spage>1680</spage><epage>1686</epage><pages>1680-1686</pages><issn>0363-5465</issn><eissn>1552-3365</eissn><coden>AJSMDO</coden><abstract>Background:
Local anesthetics are commonly administered into surgical sites as a part of multimodal pain control regimens. Liposomal bupivacaine is a novel formulation of bupivacaine designed for slow diffusion of a single dose of local anesthetic over a 72-hour period. While early results are promising in various settings, no studies have compared pain management regimens containing liposomal bupivacaine to traditional regimens in patients undergoing anterior cruciate ligament (ACL) reconstruction.
Purpose:
To evaluate liposomal bupivacaine in comparison with 0.25% bupivacaine hydrochloride (HCl) for pain control after ACL reconstruction.
Study Design:
Randomized controlled trial; Level of evidence, 1.
Methods:
A total of 32 adult patients undergoing primary ACL reconstruction with a soft tissue quadriceps tendon autograft between July 2014 and March 2015 were enrolled. All patients received a femoral nerve block immediately before surgery. Patients then received either a 40-mL suspension of 20 mL Exparel (1 vial of bupivacaine liposome injectable suspension) and 20 mL 0.9% injectable saline or 20 mL 0.5% bupivacaine HCl and 20 mL 0.9% injectable saline, which was administered into the graft harvest site and portal sites during surgery. Patients were given either a postoperative smartphone application or paper-based journal to record data for 1 week after ACL reconstruction.
Results:
Of the 32 patients recruited, 29 patients were analyzed (90.6%). Two patients were lost to follow-up, and 1 was excluded because of a postoperative hematoma. There were no statistically significant differences in postoperative pain, medication use, pain location, recovery room time, or mobility between the 2 study groups.
Conclusion:
There were comparable outcomes with 0.25% bupivacaine HCl at a 200-fold lower cost than liposomal bupivacaine. This study does not support the widespread use of liposomal bupivacaine for pain control after ACL reconstruction in the setting of a femoral nerve block.
Registration:
ClinicalTrials.gov NCT02189317</abstract><cop>Los Angeles, CA</cop><pub>SAGE Publications</pub><pmid>27159290</pmid><doi>10.1177/0363546516640772</doi><tpages>7</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0363-5465 |
| ispartof | The American journal of sports medicine, 2016-07, Vol.44 (7), p.1680-1686 |
| issn | 0363-5465 1552-3365 |
| language | eng |
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| source | MEDLINE; SAGE Complete; Alma/SFX Local Collection |
| subjects | Adult Anesthetics, Local - administration & dosage Anesthetics, Local - chemistry Anesthetics, Local - pharmacology Bupivacaine - administration & dosage Bupivacaine - chemistry Bupivacaine - pharmacology Double-Blind Method Female Humans Knee Liposomes Male Middle Aged Pain management Pain Management - methods Prospective Studies Skin & tissue grafts Sports medicine Surgical outcomes Young Adult |
| title | Liposomal Bupivacaine for Pain Control After Anterior Cruciate Ligament Reconstruction: A Prospective, Double-Blinded, Randomized, Positive-Controlled Trial |
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