Anterior Cruciate Ligament Rupture
Conditions
Brief summary
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.
Interventions
DRUGExparel
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.
Sponsors
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Ages between 18 and 50 chronological years undergoing ACL reconstruction using a quadriceps tendon or BTB autograft.
Exclusion criteria
* Patients with known allergies to local anesthetics * pregnant patients * patients with a history of liver disease * patients undergoing bilateral procedures * Patients undergoing revision ACL surgery and patients undergoing ACL reconstruction using pediatric physeal sparing techniques * Patients will also be excluded if any clinically significant event or condition is discovered during the time of, or after surgery that may render them medically unstable, or subject them to a surgical complication.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Numerical Rating Scale (NRS) Pain Score | Day of Surgery, Post-Operative Day 6 (Up to 144 hours) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Home Opioid Use | Day of Surgery, Post-Operative Day 6 (Up to 144 hours) | The difference in amount of Percocet (7.5/325 tablets) usage post-surgery. |
| Difference in Time to First Opioid Use | Day of Surgery, Post-Operative Day 6 (Up to 144 hours) | The time difference in hours to first Percocet (7.5/325 tablets) usage post-surgery. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from an ambulatory surgery center from July 2014 to March 2015.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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. | 16 |
| 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. | 16 |
| Total | 32 |
Baseline characteristics
| Characteristic | Bupivacaine HCl | Exparel (Liposomal Bupivacaine) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 16 Participants | 32 Participants |
| Region of Enrollment United States | 16 participants | 16 participants | 32 participants |
| Sex: Female, Male Female | 7 Participants | 5 Participants | 12 Participants |
| Sex: Female, Male Male | 9 Participants | 11 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 1 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 |
Outcome results
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.
Time frame: Day of Surgery, Post-Operative Day 6 (Up to 144 hours)
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bupivacaine HCl | Change in Numerical Rating Scale (NRS) Pain Score | Baseline (recovery room) | 3.6 units on a scale | Standard Deviation 2.1 |
| Bupivacaine HCl | Change in Numerical Rating Scale (NRS) Pain Score | Evening on the day of surgery | 5.0 units on a scale | Standard Deviation 3.7 |
| Bupivacaine HCl | Change in Numerical Rating Scale (NRS) Pain Score | Day 1 Morning | 5.7 units on a scale | Standard Deviation 2.5 |
| Bupivacaine HCl | Change in Numerical Rating Scale (NRS) Pain Score | Day 1 Evening | 5.2 units on a scale | Standard Deviation 2.6 |
| Bupivacaine HCl | Change in Numerical Rating Scale (NRS) Pain Score | Day 2 Morning | 5.1 units on a scale | Standard Deviation 2.6 |
| Bupivacaine HCl | Change in Numerical Rating Scale (NRS) Pain Score | Day 2 Evening | 4.1 units on a scale | Standard Deviation 2.4 |
| Bupivacaine HCl | Change in Numerical Rating Scale (NRS) Pain Score | Day 3 Morning | 3.7 units on a scale | Standard Deviation 2.5 |
| Bupivacaine HCl | Change in Numerical Rating Scale (NRS) Pain Score | Day 3 Evening | 3.6 units on a scale | Standard Deviation 2.5 |
| Bupivacaine HCl | Change in Numerical Rating Scale (NRS) Pain Score | Day 4 Morning | 3.3 units on a scale | Standard Deviation 2.2 |
| Bupivacaine HCl | Change in Numerical Rating Scale (NRS) Pain Score | Day 4 Evening | 3.0 units on a scale | Standard Deviation 2 |
| Bupivacaine HCl | Change in Numerical Rating Scale (NRS) Pain Score | Day 5 Morning | 3.3 units on a scale | Standard Deviation 2.1 |
| Bupivacaine HCl | Change in Numerical Rating Scale (NRS) Pain Score | Day 5 Evening | 3.1 units on a scale | Standard Deviation 2.1 |
| Bupivacaine HCl | Change in Numerical Rating Scale (NRS) Pain Score | Day 6 Morning | 3.3 units on a scale | Standard Deviation 2.2 |
| Bupivacaine HCl | Change in Numerical Rating Scale (NRS) Pain Score | Day 6 Evening | 2.4 units on a scale | Standard Deviation 2.3 |
| Exparel (Liposomal Bupivacaine) | Change in Numerical Rating Scale (NRS) Pain Score | Day 5 Morning | 2.8 units on a scale | Standard Deviation 2.5 |
| Exparel (Liposomal Bupivacaine) | Change in Numerical Rating Scale (NRS) Pain Score | Baseline (recovery room) | 4.7 units on a scale | Standard Deviation 2 |
| Exparel (Liposomal Bupivacaine) | Change in Numerical Rating Scale (NRS) Pain Score | Day 3 Evening | 4.5 units on a scale | Standard Deviation 2 |
| Exparel (Liposomal Bupivacaine) | Change in Numerical Rating Scale (NRS) Pain Score | Evening on the day of surgery | 4.1 units on a scale | Standard Deviation 2.3 |
| Exparel (Liposomal Bupivacaine) | Change in Numerical Rating Scale (NRS) Pain Score | Day 6 Morning | 2.5 units on a scale | Standard Deviation 2.4 |
| Exparel (Liposomal Bupivacaine) | Change in Numerical Rating Scale (NRS) Pain Score | Day 1 Morning | 4.5 units on a scale | Standard Deviation 2.1 |
| Exparel (Liposomal Bupivacaine) | Change in Numerical Rating Scale (NRS) Pain Score | Day 4 Morning | 4.1 units on a scale | Standard Deviation 2 |
| Exparel (Liposomal Bupivacaine) | Change in Numerical Rating Scale (NRS) Pain Score | Day 1 Evening | 5.6 units on a scale | Standard Deviation 1.7 |
| Exparel (Liposomal Bupivacaine) | Change in Numerical Rating Scale (NRS) Pain Score | Day 5 Evening | 2.5 units on a scale | Standard Deviation 2.4 |
| Exparel (Liposomal Bupivacaine) | Change in Numerical Rating Scale (NRS) Pain Score | Day 2 Morning | 4.9 units on a scale | Standard Deviation 2.5 |
| Exparel (Liposomal Bupivacaine) | Change in Numerical Rating Scale (NRS) Pain Score | Day 4 Evening | 3.6 units on a scale | Standard Deviation 2.1 |
| Exparel (Liposomal Bupivacaine) | Change in Numerical Rating Scale (NRS) Pain Score | Day 2 Evening | 4.7 units on a scale | Standard Deviation 1.9 |
| Exparel (Liposomal Bupivacaine) | Change in Numerical Rating Scale (NRS) Pain Score | Day 6 Evening | 1.4 units on a scale | Standard Deviation 2.2 |
| Exparel (Liposomal Bupivacaine) | Change in Numerical Rating Scale (NRS) Pain Score | Day 3 Morning | 4.8 units on a scale | Standard Deviation 1.7 |
Secondary
Change in Home Opioid Use
The difference in amount of Percocet (7.5/325 tablets) usage post-surgery.
Time frame: Day of Surgery, Post-Operative Day 6 (Up to 144 hours)
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bupivacaine HCl | Change in Home Opioid Use | Day of Surgery | 1.6 miligrams | Standard Deviation 1.3 |
| Bupivacaine HCl | Change in Home Opioid Use | Postoperative Day 4 | 1.7 miligrams | Standard Deviation 1.4 |
| Bupivacaine HCl | Change in Home Opioid Use | Postoperative Day 2 | 4.0 miligrams | Standard Deviation 2.1 |
| Bupivacaine HCl | Change in Home Opioid Use | Postoperative Day 5 | 1.6 miligrams | Standard Deviation 1.5 |
| Bupivacaine HCl | Change in Home Opioid Use | Postoperative Day 1 | 4.9 miligrams | Standard Deviation 2.9 |
| Bupivacaine HCl | Change in Home Opioid Use | Postoperative Day 6 | 1.6 miligrams | Standard Deviation 1.6 |
| Bupivacaine HCl | Change in Home Opioid Use | Postoperative Day 3 | 2.3 miligrams | Standard Deviation 1.9 |
| Bupivacaine HCl | Change in Home Opioid Use | Up to 72 hours | 10.2 miligrams | Standard Deviation 4.8 |
| Exparel (Liposomal Bupivacaine) | Change in Home Opioid Use | Postoperative Day 3 | 1.3 miligrams | Standard Deviation 1.5 |
| Exparel (Liposomal Bupivacaine) | Change in Home Opioid Use | Up to 72 hours | 9.3 miligrams | Standard Deviation 6.9 |
| Exparel (Liposomal Bupivacaine) | Change in Home Opioid Use | Postoperative Day 1 | 4.1 miligrams | Standard Deviation 3.2 |
| Exparel (Liposomal Bupivacaine) | Change in Home Opioid Use | Postoperative Day 2 | 2.3 miligrams | Standard Deviation 2.5 |
| Exparel (Liposomal Bupivacaine) | Change in Home Opioid Use | Day of Surgery | 2.5 miligrams | Standard Deviation 1.5 |
| Exparel (Liposomal Bupivacaine) | Change in Home Opioid Use | Postoperative Day 4 | 0.8 miligrams | Standard Deviation 1 |
| Exparel (Liposomal Bupivacaine) | Change in Home Opioid Use | Postoperative Day 5 | 0.2 miligrams | Standard Deviation 0.4 |
| Exparel (Liposomal Bupivacaine) | Change in Home Opioid Use | Postoperative Day 6 | 0.3 miligrams | Standard Deviation 0.5 |
Secondary
Difference in Time to First Opioid Use
The time difference in hours to first Percocet (7.5/325 tablets) usage post-surgery.
Time frame: Day of Surgery, Post-Operative Day 6 (Up to 144 hours)
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupivacaine HCl | Difference in Time to First Opioid Use | 3.2 hours | Standard Deviation 2.1 |
| Exparel (Liposomal Bupivacaine) | Difference in Time to First Opioid Use | 3.1 hours | Standard Deviation 0.7 |