- Email: [email protected]
Effects of Liposomal Bupivacaine on Patient Recovery after Long Spinal Fusions: A Prospective, Randomized Study
S244
NASS 31st Annual Meeting Proceedings / The Spine Journal 16 (2016) S113–S250
273. Effects of Liposomal Bupivacaine on Patient Recovery after Long Spinal Fusions: A Prospective, Randomized Study Michael S. Chang, MD1, Jan Revella, RN2, Dennis G. Crandall, MD2, Yu-Hui Chang, PhD3; 1Sonoran Spine Center, Tempe, AZ, USA; 2Sonoran Spine, Tempe, AZ, USA; 3Mayo Clinic, Scottsdale, AZ, USA BACKGROUND CONTEXT: Liposomal bupivacaine (Exparel) has been marketed as a novel way for patients to obtain sustained postop pain relief. The drug has been used in orthopedic procedures with mixed results in the literature. Most studies suggest some pain relief but whether this significantly impacts a patient’s postop course is uncertain. The drug has never been studied in larger surgical procedures such as long spinal fusion surgery where the potential to reduce perioperative narcotic consumption significantly over the course of several days may result in less opioid related complications and a shorter overall length of stay. PURPOSE: To determine if liposomal bupivacaine reduces postop narcotic use and length of stay in long spinal fusion patients. STUDY DESIGN/SETTING: Prospective, randomized, single-surgeon study. PATIENT SAMPLE: Patients undergoing 7 or more levels of spinal fusion. OUTCOME MEASURES: Visual-analog pain scale (VAS), narcotic utilization, length of stay, perioperative complication rates. METHODS: Sixty-eight consecutive patients undergoing elective spinal fusion (mean age 43.8) of at least 7 levels by a single surgeon (MSC) were prospectively randomized to receive peri-incisional injections of combined liposomal and standard bupivacaine (group L) or standard bupivacaine only (group C). There were no significant baseline demographic differences between the two groups. Postop pain scores (VAS), opioid use, length of stay and perioperative complications were recorded. IV and oral narcotic consumption from all sources were standardized to morphineequivalent units (MEU). This study was performed completely independent of industry. RESULTS: Patients receiving liposomal bupivacaine consumed less narcotics over the first three postop days, with the most significant reduction on postop day one (Day 0: 19.35 vs 28.76 MEU, Day 1: 74.85 vs 98.74, Day 2: 95.21 vs 102.82, Day 3: 87.29 vs 93.08). However, this reduction in narcotic use did not significantly impact length of stay (L: 4.4 vs C: 4.8 days) or overall postop pain scores on any day. Similarly, there were no significant differences in postop complication rates including ileus (L: 3[7.9%] vs C: 2[6.7%]) and superficial wound infection (L:0 vs C: 1[3.3%]). CONCLUSIONS: Despite significantly reducing opioid requirements in the first postop day, the use of liposomal bupivacaine did not appear to make a substantial difference in either hospital stay or perioperative complication rates on patients undergoing long spinal fusions. FDA DEVICE/DRUG STATUS: Liposomal bupivacaine (Exparel) (Approved for this indication). http://dx.doi.org/10.1016/j.spinee.2016.07.309
Saturday, October 29, 2016 9:00 AM–10:00 AM Deformity Outcomes 274. Outcomes of Open Staged Corrective Surgery in the Setting of Adult Spinal Deformity Peter G. Passias, MD1, Gregory W. Poorman, BA2, Cyrus M. Jalai, BA2, Breton Line, BS3, Bassel G. Diebo, MD4, Paul Park, MD5, Robert A. Hart, MD6, Douglas C. Burton, MD7, Frank J. Schwab, MD4, Virginie Lafage, PhD4, Shay Bess, MD2, Thomas J. Errico, MD2, International Spine Study Group8; 1NY Spine Institute, NYU Medical Center Hospital for Joint Diseases, New York, NY, USA; 2Hospital for Joint Diseases at NYU Langone Medical Center, New York, NY, USA; 3 International Spine Study Group, Arvada, CO, USA; 4Hospital for Special Surgery, New York, NY, USA; 5University of Michigan, Department of Neurosurgery, Ann Arbor, MI, USA; 6Oregon Health & Science University, Portland, OR, USA; 7University of Kansas Medical Center, Kansas City, KS, USA; 8Brighton, CO, USA BACKGROUND CONTEXT: Treating physicians may elect to stage adult spinal deformity procedures on different days in an attempt to minimize surgical morbidity. Staging may reduce mortality in high-risk patients, but resulting complication rates are understudied. PURPOSE: To analyze the difference in results between long spine fusions for ASD performed on multiple days, or all at once. STUDY DESIGN/SETTING: Retrospective review of a prospective, multicenter database. PATIENT SAMPLE: One hundred forty-two patients (71 Staged, 71 Non-Staged). OUTCOME MEASURES: Primary: intra- and periop (6 week) complication rates. Secondary: 2 year thoracolumbar and spino-pelvic radiographic parameters, 2 year HRQL changes and 2 year complication rates. METHODS: Inclusion: ASD patients ≥18 yrs with follow-up at 6 weeks and 2 years. Propensity score matching identified similar staged and simultaneous patients undergoing long spine fusions based on invasiveness, PT and SVA. Complications, HRQLs, radiographic parameters and surgical characteristics were compared between treatments with ANOVA t-tests at 3 surgical stages: intra-, peri- (6 week) and postop (>6 week). RESULTS: A total of 142 patients were included (71 staged, 71 nonstaged). Demographics, CCI and revision-status was non-different (p>.05). Even after controlling for degree of deformity and surgical invasiveness, there were significantly more complications causing reoperation in Staged (47% vs 8%, p=.021). Despite longer operative times, (652 minutes vs. 395 p<.001), there was no difference in EBL (2252 mL vs 1905 mL p=.143), Cell Saver (521.4 mL vs 675.5 mL p=.115), or intraoperative complications (p>.05). Staged specifically had greater periop complications requiring reoperation (9.9% vs 1.4% p=.029) and periop radiculopathy (7% vs 0% p=.023). Mortality, periop infection and periop wound complications also did not change between the groups (p>.05). At 2 years follow-up, incidence of revision surgery was higher in staged (21.1% vs 8.5% p=.033). HRLs were nondifferent at preop, 1 year and 2 year time points and changes from baseline to 1 year and 2 year. Staged group reported lower 6 week satisfaction (p<.001). Similarly, radiographic parameters were similar at all time points (p>.05) including changes from baseline. In a subanalysis on staging stratified by approach, combined anterior and posterior approach displayed similarly higher periop complications causing reoperation (9% vs 0% p=.013) and major postop complications (33% vs 8% p=.010). CONCLUSIONS: When comparing similar staged and nonstaged surgeries, staged spinal fusions report significantly higher rates of perioperative complications, and may have increased postop complication incidence. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. http://dx.doi.org/10.1016/j.spinee.2016.07.311
Refer to onsite annual meeting presentations and postmeeting proceedings for possible referenced figures and tables. Authors are responsible for accurately reporting disclosure and FDA device/drug status at time of abstract submission.
NASS 31st Annual Meeting Proceedings / The Spine Journal 16 (2016) S113–S250
273. Effects of Liposomal Bupivacaine on Patient Recovery after Long Spinal Fusions: A Prospective, Randomized Study Michael S. Chang, MD1, Jan Revella, RN2, Dennis G. Crandall, MD2, Yu-Hui Chang, PhD3; 1Sonoran Spine Center, Tempe, AZ, USA; 2Sonoran Spine, Tempe, AZ, USA; 3Mayo Clinic, Scottsdale, AZ, USA BACKGROUND CONTEXT: Liposomal bupivacaine (Exparel) has been marketed as a novel way for patients to obtain sustained postop pain relief. The drug has been used in orthopedic procedures with mixed results in the literature. Most studies suggest some pain relief but whether this significantly impacts a patient’s postop course is uncertain. The drug has never been studied in larger surgical procedures such as long spinal fusion surgery where the potential to reduce perioperative narcotic consumption significantly over the course of several days may result in less opioid related complications and a shorter overall length of stay. PURPOSE: To determine if liposomal bupivacaine reduces postop narcotic use and length of stay in long spinal fusion patients. STUDY DESIGN/SETTING: Prospective, randomized, single-surgeon study. PATIENT SAMPLE: Patients undergoing 7 or more levels of spinal fusion. OUTCOME MEASURES: Visual-analog pain scale (VAS), narcotic utilization, length of stay, perioperative complication rates. METHODS: Sixty-eight consecutive patients undergoing elective spinal fusion (mean age 43.8) of at least 7 levels by a single surgeon (MSC) were prospectively randomized to receive peri-incisional injections of combined liposomal and standard bupivacaine (group L) or standard bupivacaine only (group C). There were no significant baseline demographic differences between the two groups. Postop pain scores (VAS), opioid use, length of stay and perioperative complications were recorded. IV and oral narcotic consumption from all sources were standardized to morphineequivalent units (MEU). This study was performed completely independent of industry. RESULTS: Patients receiving liposomal bupivacaine consumed less narcotics over the first three postop days, with the most significant reduction on postop day one (Day 0: 19.35 vs 28.76 MEU, Day 1: 74.85 vs 98.74, Day 2: 95.21 vs 102.82, Day 3: 87.29 vs 93.08). However, this reduction in narcotic use did not significantly impact length of stay (L: 4.4 vs C: 4.8 days) or overall postop pain scores on any day. Similarly, there were no significant differences in postop complication rates including ileus (L: 3[7.9%] vs C: 2[6.7%]) and superficial wound infection (L:0 vs C: 1[3.3%]). CONCLUSIONS: Despite significantly reducing opioid requirements in the first postop day, the use of liposomal bupivacaine did not appear to make a substantial difference in either hospital stay or perioperative complication rates on patients undergoing long spinal fusions. FDA DEVICE/DRUG STATUS: Liposomal bupivacaine (Exparel) (Approved for this indication). http://dx.doi.org/10.1016/j.spinee.2016.07.309
Saturday, October 29, 2016 9:00 AM–10:00 AM Deformity Outcomes 274. Outcomes of Open Staged Corrective Surgery in the Setting of Adult Spinal Deformity Peter G. Passias, MD1, Gregory W. Poorman, BA2, Cyrus M. Jalai, BA2, Breton Line, BS3, Bassel G. Diebo, MD4, Paul Park, MD5, Robert A. Hart, MD6, Douglas C. Burton, MD7, Frank J. Schwab, MD4, Virginie Lafage, PhD4, Shay Bess, MD2, Thomas J. Errico, MD2, International Spine Study Group8; 1NY Spine Institute, NYU Medical Center Hospital for Joint Diseases, New York, NY, USA; 2Hospital for Joint Diseases at NYU Langone Medical Center, New York, NY, USA; 3 International Spine Study Group, Arvada, CO, USA; 4Hospital for Special Surgery, New York, NY, USA; 5University of Michigan, Department of Neurosurgery, Ann Arbor, MI, USA; 6Oregon Health & Science University, Portland, OR, USA; 7University of Kansas Medical Center, Kansas City, KS, USA; 8Brighton, CO, USA BACKGROUND CONTEXT: Treating physicians may elect to stage adult spinal deformity procedures on different days in an attempt to minimize surgical morbidity. Staging may reduce mortality in high-risk patients, but resulting complication rates are understudied. PURPOSE: To analyze the difference in results between long spine fusions for ASD performed on multiple days, or all at once. STUDY DESIGN/SETTING: Retrospective review of a prospective, multicenter database. PATIENT SAMPLE: One hundred forty-two patients (71 Staged, 71 Non-Staged). OUTCOME MEASURES: Primary: intra- and periop (6 week) complication rates. Secondary: 2 year thoracolumbar and spino-pelvic radiographic parameters, 2 year HRQL changes and 2 year complication rates. METHODS: Inclusion: ASD patients ≥18 yrs with follow-up at 6 weeks and 2 years. Propensity score matching identified similar staged and simultaneous patients undergoing long spine fusions based on invasiveness, PT and SVA. Complications, HRQLs, radiographic parameters and surgical characteristics were compared between treatments with ANOVA t-tests at 3 surgical stages: intra-, peri- (6 week) and postop (>6 week). RESULTS: A total of 142 patients were included (71 staged, 71 nonstaged). Demographics, CCI and revision-status was non-different (p>.05). Even after controlling for degree of deformity and surgical invasiveness, there were significantly more complications causing reoperation in Staged (47% vs 8%, p=.021). Despite longer operative times, (652 minutes vs. 395 p<.001), there was no difference in EBL (2252 mL vs 1905 mL p=.143), Cell Saver (521.4 mL vs 675.5 mL p=.115), or intraoperative complications (p>.05). Staged specifically had greater periop complications requiring reoperation (9.9% vs 1.4% p=.029) and periop radiculopathy (7% vs 0% p=.023). Mortality, periop infection and periop wound complications also did not change between the groups (p>.05). At 2 years follow-up, incidence of revision surgery was higher in staged (21.1% vs 8.5% p=.033). HRLs were nondifferent at preop, 1 year and 2 year time points and changes from baseline to 1 year and 2 year. Staged group reported lower 6 week satisfaction (p<.001). Similarly, radiographic parameters were similar at all time points (p>.05) including changes from baseline. In a subanalysis on staging stratified by approach, combined anterior and posterior approach displayed similarly higher periop complications causing reoperation (9% vs 0% p=.013) and major postop complications (33% vs 8% p=.010). CONCLUSIONS: When comparing similar staged and nonstaged surgeries, staged spinal fusions report significantly higher rates of perioperative complications, and may have increased postop complication incidence. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. http://dx.doi.org/10.1016/j.spinee.2016.07.311
Refer to onsite annual meeting presentations and postmeeting proceedings for possible referenced figures and tables. Authors are responsible for accurately reporting disclosure and FDA device/drug status at time of abstract submission.