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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03270514
Other study ID # PRO17060305
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date November 15, 2018
Est. completion date February 25, 2020

Study information

Verified date August 2021
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to evaluate the analgesic efficacy and safety of wound infiltration with liposomal bupivacaine (LB) in patients undergoing cardiac surgery with sternotomy and cardiopulmonary bypass (CPB) and compare it with bupivacaine hydrochloride infiltration


Description:

There are no studies to date on the use of LB infiltration and its analgesic efficacy in cardiac surgery done through sternotomy, even though the majority of cardiac surgeries utilize this approach. Moderate to severe pain is common in patients undergoing these surgeries and is usually inadequately treated. Other various pain treatment modalities such as opioid and neuraxial anesthesia are avoided due to potentially dangerous side effects in this cohort. The efficacy of local anesthesia techniques, such as bupivacaine, are limited due to short duration of action and increased incidence of wound infection. On the other hand, slow release liposomal bupivacaine may last up to 72 hours, indicating it's potential for more adequate analgesia compared to bupivacaine.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date February 25, 2020
Est. primary completion date December 13, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Open cardiac surgery through sternotomy approach (eg. coronary artery bypass graft, valvular heart procedures, as well as other open cardiac procedures along with coronary artery bypass) - Surgery with the use of cardiopulmonary bypass Exclusion Criteria: - Minimally invasive heart surgery through thoracotomy approach - Patient undergoing procedures under deep hypothermic circulatory arrest - Patients with active infections such as infective endocarditis - Emergency surgery - Patients undergoing transplantations and ventricular assist device insertion - Patients on any mechanical circulatory support preoperatively - Patient's refusal - End stage liver or renal disease - Allergy to bupivacaine - Patient who cannot understand the study procedure or refuse to participate - Redo-sternotomy - Participation in another study - Patients with severe right or left ventricular dysfunction (EF< 25%) - Patients requiring chronic opioids for chronic pain condition

Study Design


Intervention

Drug:
Exparel Injectable Product
Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
Bupivacaine Hydrochloride
Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)

Locations

Country Name City State
United States UPMC Presbyterian Hospital Pittsburgh Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Kathirvel Subramaniam Pacira Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

References & Publications (28)

Abdelsattar JM, Boughey JC, Fahy AS, Jakub JW, Farley DR, Hieken TJ, Degnim AC, Goede W, Mohan AT, Harmsen WS, Niesen AD, Tran NV, Bakri K, Jacobson SR, Lemaine V, Saint-Cyr M. Comparative Study of Liposomal Bupivacaine Versus Paravertebral Block for Pain Control Following Mastectomy with Immediate Tissue Expander Reconstruction. Ann Surg Oncol. 2016 Feb;23(2):465-70. doi: 10.1245/s10434-015-4833-4. Epub 2015 Aug 26. — View Citation

Ayad S, Babazade R, Elsharkawy H, Nadar V, Lokhande C, Makarova N, Khanna R, Sessler DI, Turan A. Comparison of Transversus Abdominis Plane Infiltration with Liposomal Bupivacaine versus Continuous Epidural Analgesia versus Intravenous Opioid Analgesia. PLoS One. 2016 Apr 15;11(4):e0153675. doi: 10.1371/journal.pone.0153675. eCollection 2016. Erratum in: PLoS One. 2016;11(9):e0163687. — View Citation

Balkhy HH, Arnsdorf S, Krienbring D, Urban J. Liposome Bupivacaine for Postsurgical Analgesia in Patients Undergoing Robotically Assisted Cardiac Surgery. Innovations (Phila). 2015 Nov-Dec;10(6):416-9. doi: 10.1097/IMI.0000000000000190. — View Citation

Barrington JW, Halaszynski TM, Sinatra RS, Expert Working Group On Anesthesia And Orthopaedics Critical Issues In Hip And Knee Replacement Arthroplasty FT. Perioperative pain management in hip and knee replacement surgery. Am J Orthop (Belle Mead NJ). 2014 Apr;43(4 Suppl):S1-S16. — View Citation

Barrington JW, Olugbode O, Lovald S, Ong K, Watson H, Emerson RH Jr. Liposomal Bupivacaine: A Comparative Study of More Than 1000 Total Joint Arthroplasty Cases. Orthop Clin North Am. 2015 Oct;46(4):469-77. doi: 10.1016/j.ocl.2015.06.003. Epub 2015 Aug 6. Review. — View Citation

Beck DE, Margolin DA, Babin SF, Russo CT. Benefits of a Multimodal Regimen for Postsurgical Pain Management in Colorectal Surgery. Ochsner J. 2015 Winter;15(4):408-12. — View Citation

Bigeleisen PE, Goehner N. Novel approaches in pain management in cardiac surgery. Curr Opin Anaesthesiol. 2015 Feb;28(1):89-94. doi: 10.1097/ACO.0000000000000147. Review. — View Citation

Cherian JJ, Barrington J, Elmallah RK, Chughtai M, Mistry JB, Mont MA. Liposomal Bupivacaine Suspension, Can Reduce Length of Stay and Improve Discharge Status of Patients Undergoing Total Hip Arthroplasty. Surg Technol Int. 2015 Nov;27:235-9. — View Citation

Golf M, Daniels SE, Onel E. A phase 3, randomized, placebo-controlled trial of DepoFoam® bupivacaine (extended-release bupivacaine local analgesic) in bunionectomy. Adv Ther. 2011 Sep;28(9):776-88. doi: 10.1007/s12325-011-0052-y. Epub 2011 Aug 12. — View Citation

Grieff AN, Ghobrial GM, Jallo J. Use of liposomal bupivacaine in the postoperative management of posterior spinal decompression. J Neurosurg Spine. 2016 Jul;25(1):88-93. doi: 10.3171/2015.11.SPINE15957. Epub 2016 Mar 4. — View Citation

Hutchins J, Delaney D, Vogel RI, Ghebre RG, Downs LS Jr, Carson L, Mullany S, Teoh D, Geller MA. Ultrasound guided subcostal transversus abdominis plane (TAP) infiltration with liposomal bupivacaine for patients undergoing robotic assisted hysterectomy: A prospective randomized controlled study. Gynecol Oncol. 2015 Sep;138(3):609-13. doi: 10.1016/j.ygyno.2015.06.008. Epub 2015 Jun 6. — View Citation

Hutchins JL, Kesha R, Blanco F, Dunn T, Hochhalter R. Ultrasound-guided subcostal transversus abdominis plane blocks with liposomal bupivacaine vs. non-liposomal bupivacaine for postoperative pain control after laparoscopic hand-assisted donor nephrectomy: a prospective randomised observer-blinded study. Anaesthesia. 2016 Aug;71(8):930-7. doi: 10.1111/anae.13502. Epub 2016 May 30. — View Citation

Kalogera E, Bakkum-Gamez JN, Weaver AL, Moriarty JP, Borah BJ, Langstraat CL, Jankowski CJ, Lovely JK, Cliby WA, Dowdy SC. Abdominal Incision Injection of Liposomal Bupivacaine and Opioid Use After Laparotomy for Gynecologic Malignancies. Obstet Gynecol. 2016 Nov;128(5):1009-1017. doi: 10.1097/AOG.0000000000001719. — View Citation

Khalil KG, Boutrous ML, Irani AD, Miller CC 3rd, Pawelek TR, Estrera AL, Safi HJ. Operative Intercostal Nerve Blocks With Long-Acting Bupivacaine Liposome for Pain Control After Thoracotomy. Ann Thorac Surg. 2015 Dec;100(6):2013-8. doi: 10.1016/j.athoracsur.2015.08.017. Epub 2015 Oct 24. — View Citation

Kim J, Burke SM, Kryzanski JT, Roberts RJ, Roguski M, Qu E, Hwang SW, Liu PP, Desilier A, Riesenburger RI. The Role of Liposomal Bupivacaine in Reduction of Postoperative Pain After Transforaminal Lumbar Interbody Fusion: A Clinical Study. World Neurosurg. 2016 Jul;91:460-7. doi: 10.1016/j.wneu.2016.04.058. Epub 2016 Apr 22. — View Citation

Knight RB, Walker PW, Keegan KA, Overholser SM, Baumgartner TS, Ebertowski JS 2nd, Aden JK, White MA. A Randomized Controlled Trial for Pain Control in Laparoscopic Urologic Surgery: 0.25% Bupivacaine Versus Long-Acting Liposomal Bupivacaine. J Endourol. 2015 Sep;29(9):1019-24. doi: 10.1089/end.2014.0769. Epub 2015 Jun 5. — View Citation

Knudson RA, Dunlavy PW, Franko J, Raman SR, Kraemer SR. Effectiveness of Liposomal Bupivacaine in Colorectal Surgery: A Pragmatic Nonsponsored Prospective Randomized Double Blinded Trial in a Community Hospital. Dis Colon Rectum. 2016 Sep;59(9):862-9. doi: 10.1097/DCR.0000000000000648. — View Citation

Kuang MJ, Du Y, Ma JX, He W, Fu L, Ma XL. The Efficacy of Liposomal Bupivacaine Using Periarticular Injection in Total Knee Arthroplasty: A Systematic Review and Meta-Analysis. J Arthroplasty. 2017 Apr;32(4):1395-1402. doi: 10.1016/j.arth.2016.12.025. Epub 2016 Dec 23. Review. — View Citation

Ma J, Zhang W, Yao S. Liposomal bupivacaine infiltration versus femoral nerve block for pain control in total knee arthroplasty: A systematic review and meta-analysis. Int J Surg. 2016 Dec;36(Pt A):44-55. doi: 10.1016/j.ijsu.2016.10.007. Epub 2016 Oct 11. Review. — View Citation

Morales R Jr, Mentz H 3rd, Newall G, Patronella C, Masters O 3rd. Use of abdominal field block injections with liposomal bupivicaine to control postoperative pain after abdominoplasty. Aesthet Surg J. 2013 Nov 1;33(8):1148-53. doi: 10.1177/1090820X13510720. Epub 2013 Nov 8. — View Citation

Okoroha KR, Lynch JR, Keller RA, Korona J, Amato C, Rill B, Kolowich PA, Muh SJ. Liposomal bupivacaine versus interscalene nerve block for pain control after shoulder arthroplasty: a prospective randomized trial. J Shoulder Elbow Surg. 2016 Nov;25(11):1742-1748. doi: 10.1016/j.jse.2016.05.007. Epub 2016 Jul 14. — View Citation

Oppenheimer AJ, Fiala TGS, Oppenheimer DC. Direct Transversus Abdominis Plane Blocks With Exparel During Abdominoplasty. Ann Plast Surg. 2016 Nov;77(5):499-500. doi: 10.1097/SAP.0000000000000659. — View Citation

Routman HD, Israel LR, Moor MA, Boltuch AD. Local injection of liposomal bupivacaine combined with intravenous dexamethasone reduces postoperative pain and hospital stay after shoulder arthroplasty. J Shoulder Elbow Surg. 2017 Apr;26(4):641-647. doi: 10.1016/j.jse.2016.09.033. Epub 2016 Nov 15. — View Citation

Smoot JD, Bergese SD, Onel E, Williams HT, Hedden W. The efficacy and safety of DepoFoam bupivacaine in patients undergoing bilateral, cosmetic, submuscular augmentation mammaplasty: a randomized, double-blind, active-control study. Aesthet Surg J. 2012 Jan;32(1):69-76. doi: 10.1177/1090820X11430831. Epub 2011 Dec 16. — View Citation

Sun XL, Zhao ZH, Ma JX, Li FB, Li YJ, Meng XM, Ma XL. Continuous Local Infiltration Analgesia for Pain Control After Total Knee Arthroplasty: A Meta-analysis of Randomized Controlled Trials. Medicine (Baltimore). 2015 Nov;94(45):e2005. doi: 10.1097/MD.0000000000002005. Review. — View Citation

Tong YC, Kaye AD, Urman RD. Liposomal bupivacaine and clinical outcomes. Best Pract Res Clin Anaesthesiol. 2014 Mar;28(1):15-27. doi: 10.1016/j.bpa.2014.02.001. Epub 2014 Mar 15. Review. — View Citation

Vyas KS, Rajendran S, Morrison SD, Shakir A, Mardini S, Lemaine V, Nahabedian MY, Baker SB, Rinker BD, Vasconez HC. Systematic Review of Liposomal Bupivacaine (Exparel) for Postoperative Analgesia. Plast Reconstr Surg. 2016 Oct;138(4):748e-756e. doi: 10.1097/PRS.0000000000002547. Review. — View Citation

Yu SW, Szulc AL, Walton SL, Davidovitch RI, Bosco JA, Iorio R. Liposomal Bupivacaine as an Adjunct to Postoperative Pain Control in Total Hip Arthroplasty. J Arthroplasty. 2016 Jul;31(7):1510-5. doi: 10.1016/j.arth.2016.01.004. Epub 2016 Jan 21. — View Citation

* Note: There are 28 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other Delirium Patients will be assessed for delirium using the Intensive Care Delirium Screening Checklist (ICDSC) Assessment will be administered at 48 hours post-operatively
Other Delirium Patients will be assessed for delirium using the Intensive Care Delirium Screening Checklist (ICDSC) Assessment will be administered at 72 hours post-operatively
Other Patient Satisfaction Patient will give an assessment regarding pain management on a scale of 0 - 10 with 0 indicating the lowest satisfaction with pain management and 10 indicating the highest satisfaction with pain management Given at the time of discharge up to 30 days post-operatively
Other Chronic Pain Assessment Subjects will be asked the two following questions: "Are you currently experiencing pain?" as well as "Are you experiencing moderate to severe pain?" with moderate to severe indicated as a pain score of 4-10 on 0 to 10 scale, with 0 being no pain at all and 10 being the worst pain imaginable. 6 months after surgery
Other Chronic Pain Assessment Subjects will be asked the two following questions: "Are you currently experiencing pain?" as well as "Are you experiencing moderate to severe pain?" with moderate to severe indicated as a pain score of 4-10 on 0 to 10 scale, with 0 being no pain at all and 10 being the worst pain imaginable. 12 months after surgery
Other Serum Cortisol Levels Stress response suppression as a result of treatment will be evaluated by comparing hormone levels between the groups. Serum cortisol levels will be taken to measure this. Measured 8, 48, and 72 hours post-operatively
Primary Post-operative Pain Intensity Postoperative pain scores evaluated by numeric rating scale or (NRS) where 0- no pain and 10- worst pain, at rest and at movement NRS scores will be evaluated every 4 hours until 24 hours post-operatively, every 8 hours until 48 hours post-operatively, and every 12 hours for 72 hours post-operatively
Primary Total Narcotic Consumption All narcotics administered in the first 0-8, 8-24, 24-48, and 48-72 hours and the total narcotics administered in the 0-72 hours postoperative period(PCA narcotics, nurse-administered IV narcotics, and oral narcotics). All narcotics will be converted to total IV morphine equivalent for comparison between two groups. 0-72 hours post-operative period
Secondary Time to Extubation The time it takes until the patient is extubated post-operatively will be measured From the end of surgery until the patient is extubated up to 72 hours post-operatively
Secondary Patient Time to Mobilization The time it takes until patient ambulates will be measured From time of end of surgery to time of mobilization up to 72 hours or discharge, *assessed up to 120 hours*
Secondary Patient Time to Out of Bed to Chair The time it takes until the patient advances from bedrest to out of bed (OOB) to chair will be measured From time of end of surgery to time of mobilization up to 72 hours post-operatively
Secondary Patient Time to Oral Intake The time it takes until the patient is able to/medically cleared to consume food or liquid will be measured From time of end of surgery to time of oral intake up to 72 hours post-operatively or until hospital discharge
Secondary Non-invasive Ventilation (NIV) Requirement Episodes of NIV such as upper airway masks or similar devices will be quantified From time of end of surgery to 72 hours post-operatively or until hospital discharge
Secondary Re-intubation Instances of re-intubation will be recorded From time of end of surgery to patient discharge up to one week
Secondary Use of Incentive Spirometry Frequency of incentive spirometry will be measured From time of end of surgery to 72 hours post-operatively
Secondary Post-operative Nausea and Vomiting Whether a patient experiences at least one episode of nausea and emesis will be measured From time of end of surgery to 72 hours post-operatively
Secondary Major Organ Dysfunction Organ systems such as cardiac, renal, respiratory, and nervous system failure/dysfunction in accordance with the Society of Thoracic Surgeon's database will be noted From date of surgery assessed up to 30 day post-operatively
Secondary Length of Hospital and ICU Stay Length of both hospital and ICU stay will be measured From date of surgery assessed up to 30 day post-operatively
Secondary Hospital Readmission Readmission to hospital will be noted From end of surgery assessed up to 30 days post-operatively
Secondary Mortality Mortality will be noted at specific timepoints From end of surgery assessed up to 30 days post-operatively
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