Anesthesia, Opioid Use, Pain, Acute, Surgery
Conditions
Brief summary
Liposomal bupivacaine has gained interest in recent literature for its potential to be an effective adjunct to other pain control modalities in a multi-modal approach to post-operative pain control. The goal of this investigation is to compare the efficacy of local administration of liposomal bupivacaine versus the efficacy of a peripheral nerve block in terms of post-operative pain scores after elective ankle and hindfoot surgery. The investigators hypothesize that there will not be a significant difference in the pain scores of these two groups in opioid naïve patients.
Detailed description
Liposomal bupivacaine has gained interest in recent literature for its potential to be an effective adjunct to other pain control modalities in a multi-modal approach to post-operative pain control. Liposomal bupivacaine is an analgesic that is suspended in lipids to allow for gradual release of the analgesic over a 72-hour period (NAMDARI). From prior literature, the utilization of local analgesics infiltrated into surgical sites have been shown to reduce pain in the immediate post-operative period in foot and ankle surgery (GADEK). However, the evaluation of liposomal bupivacaine in foot and ankle surgery is limited. One prospective study found that the addition to liposomal bupivacaine to a multi-modal pain management protocol for forefoot surgery resulted in decreased pain scores during the first four post-operative days as well as fewer refills of opioid pain medication prescriptions, although both findings were not statically significant (ROBBINS). As the general medical community and public policy makers continue to focus on decreasing the amount of opioid pain medications prescribed and available in the community due to the opioid epidemic, liposomal bupivacaine has the potential to be a useful adjunct in the management of post-operative pain without reliance on opioid prescriptions. The goal of this investigation is to compare the efficacy of local administration of liposomal bupivacaine versus the efficacy of a peripheral nerve block in terms of post-operative pain scores after elective ankle and hindfoot surgery. The investigators hypothesize that there will not be a significant difference in the pain scores of these two groups in opioid naïve patients. Furthermore, this study aims to determine if there are differences in the amount of opioid medications utilized for post-operative pain control, patient satisfaction scores, functional outcomes, complications, and unscheduled healthcare contact between the two groups. In order to accomplish these aims, a randomized, controlled investigation will be conducted.
Interventions
DRUGLiposomal bupivacaine
Local infiltration of 20cc of Liposomal Bupivacaine infiltrated to the surgical area
DRUGPeripheral Nerve Block
Peripheral Nerve Block performed by anesthesia team (blocks will be given by same anesthesia provider utilizing same technique every time in order to reduce variations in delivery of peripheral nerve block).
Sponsors
Geisinger Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients 18 years of age or older 2. Patients undergoing elective primary ankle or hindfoot surgery (ankle arthrodesis, subtalar arthrodesis, triple arthrodesis, total ankle arthroplasty, peroneal tendon debridement/transfer, Cavus Reconstruction, Medial Displacement Calcaneal Osteotomy, Dwyer Osteotomy)
Exclusion criteria
1. Patients who are undergoing revision surgical procedure 2. Patients who have taken opioid pain medications in the past 3 months prior to surgical procedure 3. Patients who have allergies to any of the medications or components of medications investigated in the study 4. Patients currently incarcerated 5. Patients who cannot read and speak English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale Pain Score | Baseline and 6 weeks | Best 0-10 worst - Continuous scale to measure current pain level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morphine Equivalents | 0-6 weeks | morphine equivalents consumed for post-operative pain control |
| Investigator-developed, Pain Satisfaction Score | 0-6 weeks | asks patients to rate their level of satisfaction with their pain control on a scale of 0-10, 0 being not satisfied at all and 10 being highly satisfied |
| Range of Motion | 0-6 weeks | range of motion measured using goniometer |
| Number of Participants With Complications | 6 weeks | complications after surgery including infection and delayed healing |
| Number of Participants With Unscheduled Healthcare Contact | 6 weeks | unscheduled healthcare contact includes patient calls/messages, emergency room visits, or scheduled clinic visits |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Liposomal Bupivacaine Group No peripheral nerve block will be given. Local infiltration of 20cc of Liposomal Bupivacaine infiltrated to the surgical area.
Liposomal bupivacaine: Local infiltration of 20cc of Liposomal Bupivacaine infiltrated to the surgical area | 1 |
| Peripheral Nerve Block Group Peripheral Nerve Block performed by anesthesia team (blocks will be given by same anesthesia provider utilizing same technique every time in order to reduce variations in delivery of peripheral nerve block). No local analgesic agent infiltration
Peripheral Nerve Block: Peripheral Nerve Block performed by anesthesia team (blocks will be given by same anesthesia provider utilizing same technique every time in order to reduce variations in delivery of peripheral nerve block). | 0 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Data and outcome measures not tabulated due to discontinued enrollment. | 1 | 0 |
Baseline characteristics
| Characteristic | Liposomal Bupivacaine Group | Total | Peripheral Nerve Block Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants | — |
| Age, Continuous | 48 years STANDARD_DEVIATION 0 | 48 years STANDARD_DEVIATION 0 | — |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 1 participants | 1 participants | — |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 0 |
| other Total, other adverse events | 0 / 1 | 0 / 0 |
| serious Total, serious adverse events | 0 / 1 | 0 / 0 |
Outcome results
Primary
Visual Analog Scale Pain Score
Best 0-10 worst - Continuous scale to measure current pain level
Time frame: Baseline and 6 weeks
Population: One participant analyzed at baseline as only one total participant was enrolled. No data was displayed at 6 weeks time frame because data was not collected by investigator(s).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Liposomal Bupivacaine Group | Visual Analog Scale Pain Score | Baseline | 6 score on a scale |
Secondary
Investigator-developed, Pain Satisfaction Score
asks patients to rate their level of satisfaction with their pain control on a scale of 0-10, 0 being not satisfied at all and 10 being highly satisfied
Time frame: 0-6 weeks
Population: Data was not collected by investigator(s).
Secondary
Morphine Equivalents
morphine equivalents consumed for post-operative pain control
Time frame: 0-6 weeks
Population: Data was not collected by investigator(s).
Secondary
Number of Participants With Complications
complications after surgery including infection and delayed healing
Time frame: 6 weeks
Population: One participant analyzed as only one total participant was enrolled.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liposomal Bupivacaine Group | Number of Participants With Complications | 0 Participants |
| Peripheral Nerve Block Group | Number of Participants With Complications | 0 Participants |
Secondary
Number of Participants With Unscheduled Healthcare Contact
unscheduled healthcare contact includes patient calls/messages, emergency room visits, or scheduled clinic visits
Time frame: 6 weeks
Population: One participant analyzed as only one total participant was enrolled.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liposomal Bupivacaine Group | Number of Participants With Unscheduled Healthcare Contact | 0 Participants |
| Peripheral Nerve Block Group | Number of Participants With Unscheduled Healthcare Contact | 0 Participants |
Secondary
Range of Motion
range of motion measured using goniometer
Time frame: 0-6 weeks
Population: Data was not collected by investigator(s).