Comparing liposomal bupivacaine and nerve catheters for pain management after below-knee amputations
A Prospective, Randomized Trial of Liposomal Bupivacaine Compared to Continuous Nerve Catheters on Pain Control and Post-Operative Opioid Use in Receiving Popliteal Nerve Blocks for Below the Knee Amputation
This study is testing whether a new pain relief option called liposomal bupivacaine works better than traditional nerve catheters for people recovering from below-knee amputations.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | MaineHealth Academic / other |
| Locations | 1 site (Portland, Maine) |
| Trial ID | NCT05140499 on ClinicalTrials.gov |
What this trial studies
This pilot trial aims to gather preliminary data on the effectiveness of liposomal bupivacaine versus continuous peripheral nerve catheters for managing postoperative pain in patients undergoing below-knee amputations. The study will assess pain scores, opioid consumption, and length of hospital stay in participants randomized to receive either treatment. Additionally, it will explore the incidence of phantom limb pain one month post-surgery. The findings will help design a larger, more definitive study in the future.
Who should consider this trial
Good fit: Ideal candidates include English-speaking adults scheduled for primary amputation or stump revision with an ASA classification of I-IV.
Not a fit: Patients with allergies to local anesthetics, existing infections, or those with a BMI over 40 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing limb amputations.
How similar studies have performed: While the use of liposomal bupivacaine is established, this specific comparison with nerve catheters has not been previously studied, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Portland, Maine
- Maine Medical Center — Portland, Maine, United States (Recruiting)
Study contacts
- Principal investigator: Ryan Mountjoy, MD — MaineHealth
- Study coordinator: Janelle M Richard
- Email: richaj3@mmc.org
- Phone: 2076622862
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.