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This study will consist of 80 patients ages 18 to 50 at the Emory Orthopaedic and Spine Center who are undergoing Anterior Cruciate Ligament (ACL) reconstruction with a quadriceps tendon autograft or bone patellar tendon bone autograft by Dr. Karas or Dr. Xerogeanes. Patients will be randomized into treatment and control arms. The treatment arm will include 40 patients receiving liposomal bupivacaine intra-operatively in addition to the current standard pain control regimen. The control group will include 40 patients receiving the standard post-operative pain control regimen. Patients will be assessed to identify differences in post-operative pain, satisfaction, as well as concomitant pain medication use. Post-operative range of motion will also be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exparel | Experimental | This arm will receive Exparel |
|
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exparel | Drug | For the treatment group a total of 40 cc consisting of 20 cc of 1.3% Exparel® and 20 cc of 0.5 % marcaine will be administered to the ACL harvest site, into the periosteum surrounding the distal tibial tunnel site, and in the proximity of the skin incisions. No infiltration of Exparel will be provided intra-articularly. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Numerical Rating Scale (NRS) Pain Score | The numerical rating scale (NRS) pain score is a self-reported pain scale from 0 to 10 where zero is equal to "no pain" and ten is equal to "worst possible" pain. The score was recorded every 12 hours for up to 144 hours (six days) post-operatively. | Day of Surgery, Post-Operative Day 6 (Up to 144 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Home Opioid Use | The difference in amount of Percocet (7.5/325 tablets) usage post-surgery. | Day of Surgery, Post-Operative Day 6 (Up to 144 hours) |
| Difference in Time to First Opioid Use |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Xerogeanes, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Orthopaedic and Spine Center | Atlanta | Georgia | 30324 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27159290 | Derived | Premkumar A, Samady H, Slone H, Hash R, Karas S, Xerogeanes J. Liposomal Bupivacaine for Pain Control After Anterior Cruciate Ligament Reconstruction: A Prospective, Double-Blinded, Randomized, Positive-Controlled Trial. Am J Sports Med. 2016 Jul;44(7):1680-6. doi: 10.1177/0363546516640772. Epub 2016 Apr 25. |
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Of the fifty participants who consented for the study, 18 participants who had different graph types were excluded to avoid a potential confounder. Thirty two participants were included in the overall study who had identical graph types.
Participants were recruited from an ambulatory surgery center from July 2014 to March 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bupivacaine HCl | Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received 20 mL 0.25% bupivacaine HCl and 20 ml 0.9% injectable saline administered into the graft harvest site and portal sites during surgery. |
| FG001 | Exparel (Bupivacaine Liposome) | Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received a 40-mL suspension of 20 mL Exparel (1 vial of bupivacaine liposome injectable suspension) and 20 mL 0.9% injectable saline administered into the graft harvest site and portal sites during surgery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bupivacaine HCl | Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received 20 mL 0.25% bupivacaine HCl and 20 ml 0.9% injectable saline administered into the graft harvest site and portal sites during surgery. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Numerical Rating Scale (NRS) Pain Score | The numerical rating scale (NRS) pain score is a self-reported pain scale from 0 to 10 where zero is equal to "no pain" and ten is equal to "worst possible" pain. The score was recorded every 12 hours for up to 144 hours (six days) post-operatively. | Participants who underwent ACL reconstruction surgery and returned a completed post-operative pain and medication journal (bupivacaine HCl group). Participants who underwent ACL reconstruction surgery, returned a completed post-operative pain and medication journal, and did not require reoperation (Exparel liposomal/bupivacaine group). | Posted | Mean | Standard Deviation | units on a scale | Day of Surgery, Post-Operative Day 6 (Up to 144 hours) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bupivacaine HCl | Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received 20 mL 0.25% bupivacaine HCl and 20 ml 0.9% injectable saline administered into the graft harvest site and portal sites during surgery. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post-operative Hematoma | Injury, poisoning and procedural complications |
The study lacked a third comparison group of participants who received placebo which may have provided another internal control. Additionally, there was a difference in the total milligrams of bupivacaine administered in each study group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John W Xerogeanes, MD | Emory University | 404-778-7202 | jxeroge@emory.edu |
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| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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The time difference in hours to first Percocet (7.5/325 tablets) usage post-surgery.
| Day of Surgery, Post-Operative Day 6 (Up to 144 hours) |
| BG001 |
| Exparel (Liposomal Bupivacaine) |
Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received a 40-mL suspension of 20 mL Exparel (1 vial of bupivacaine liposome injectable suspension) and 20 mL 0.9% injectable saline administered into the graft harvest site and portal sites during surgery. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Exparel (Liposomal Bupivacaine) | Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received a 40-mL suspension of 20 mL Exparel (1 vial of bupivacaine liposome injectable suspension) and 20 mL 0.9% injectable saline administered into the graft harvest site and portal sites during surgery. |
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| Secondary | Change in Home Opioid Use | The difference in amount of Percocet (7.5/325 tablets) usage post-surgery. | Participants who underwent ACL reconstruction surgery and returned a completed post-operative pain and medication journal (bupivacaine HCl group). Participants who underwent ACL reconstruction surgery, returned a completed post-operative pain and medication journal, and did not require reoperation (Exparel liposomal/bupivacaine group). | Posted | Mean | Standard Deviation | miligrams | Day of Surgery, Post-Operative Day 6 (Up to 144 hours) |
|
|
|
| Secondary | Difference in Time to First Opioid Use | The time difference in hours to first Percocet (7.5/325 tablets) usage post-surgery. | Participants who underwent ACL reconstruction surgery and returned a completed post-operative pain and medication journal (bupivacaine HCl group). Participants who underwent ACL reconstruction surgery, returned a completed post-operative pain and medication journal, and did not require reoperation (Exparel liposomal/bupivacaine group). | Posted | Mean | Standard Deviation | hours | Day of Surgery, Post-Operative Day 6 (Up to 144 hours) |
|
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| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Exparel (Bupivacaine Liposome) | Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received a 40-mL suspension of 20 mL Exparel (1 vial of bupivacaine liposome injectable suspension) and 20 mL 0.9% injectable saline administered into the graft harvest site and portal sites during surgery. | 0 | 16 | 1 | 16 |
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| Postoperative Day 1 |
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| Postoperative Day 2 |
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| Postoperative Day 3 |
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| Postoperative Day 4 |
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| Postoperative Day 5 |
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| Postoperative Day 6 |
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