Amputation, Pain, Postoperative
Conditions
Brief summary
Through this pilot prospective trial, we aim to obtain preliminary data investigating the effectiveness of perineural catheters and liposomal bupivacaine, both currently accepted as standard care at Maine Medical Center, for the management of post-limb amputation pain. We will use the data that we collect to inform the design of a larger, appropriately powered study.
Detailed description
Lower extremity amputation is a common surgical procedure often due to limb ischemia or complications related to diabetes mellitus. Managing postoperative pain can be quite challenging in this patient population and persistent post-surgical pain is not uncommon. Peripheral nerve catheters (PNCs) that deliver a continuous infusion of local anesthetic have been shown to provide analgesic benefit dependent upon infusion duration and in the absence of catheter malfunction. Unfortunately, PNCs can be difficult to place and rates of dislodgement are estimated at 30%. Single shot regional nerve blocks using liposomal bupivacaine are much easier to perform than PNCs and can provide up to 72 hours of pain relief, eliminating the need for catheter placement. To date, no study has investigated the effects of liposomal bupivacaine compared to PNCs for post-surgical pain control. In this pilot study, we intend to compare pain scores, opioid consumption, and length of stay in patients randomized to both treatment strategies. We also intend to conduct an exploratory analysis investigating incidence of phantom limb pain one month following surgery. Our results will inform the design of a larger powered study to investigate treatment effects.
Interventions
DRUGLiposomal bupivacaine
Popliteal nerve block
Continuous nerve catheter
Sponsors
Aurora Quaye
MaineHealth
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologists Physical Status Classification I-IV * Scheduled for primary amputation or stump revision * English speaking
Exclusion criteria
* Patients unable to cooperate or consent to the study * Allergy to local anesthetics * Existing infection at planned needle insertion site * BMI \> 40kg/m2 * Patients with a history of coagulopathy * Emergency amputations * Contralateral amputations * Patients with a substance use disorder diagnosis * Patients on opioids \>90 morphine milligram equivalents (MME)/day
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Assessed by Numerical Rating Scale (NRS) | 72 hours post-operatively | Average NRS pain scores (0-10, 0=no pain, 10=worst possible pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption | 72 hours post-operatively | Total amount of opioid medication given, in morphine milligram equivalents |
| Post-operative Length of Stay | Measured from surgical stop time to discharge time, an average of 5 days. | Post-operative length of stay in hours |
| Post-operative Pain Assessed by the Short Form McGill Pain Questionnaire-2 (SFMPQ-2) | 30 days following surgery | Total SFMPQ-2 score (low score of 0, no pain to a high score of 220, worst possible pain) |
| Phantom Limb Pain Assessed Using Questions From the Trinity Amputation and Prosthesis Experiences Scales-Revised (TAPES-R) | 30 days following surgery | Phantom Limb Pain was measured using questions 4 and 5 from Part II of the TAPES-R (scores can range from 0, no pain, to 22, severe pain) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAurora Quaye, MD
MaineHealth
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 54 years STANDARD_DEVIATION 15 |
| Daily Opioid Use | 40 MME/day |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 6 |
| other Total, other adverse events | 0 / 5 | 0 / 6 |
| serious Total, serious adverse events | 0 / 5 | 0 / 6 |
Outcome results
None listed