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Liposomal Bupivacaine vs Continuous Nerve Catheters for Below the Knee Amputations

Sponsor
Ryan Mountjoy, MD (Other)
Overall Status
Recruiting
CT.gov ID
NCT05140499
Collaborator
MaineHealth (Other)
30
Enrollment
1
Location
2
Arms
5.6
Anticipated Duration (Months)
5.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Liposomal bupivacaine
  • Drug: Bupivacaine Hydrochloride 0.5 % Injectable Solution
 Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Other
Official Title:
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
Anticipated Study Start Date :
Aug 15, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Jan 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Single Shot Perineural Popliteal Nerve Block

Single shot perineural popliteal nerve block injection of 10cc 13.3% liposomal bupivacaine combined with 15cc 0.50% bupivacaine hydrochloride within one hour prior to surgery

Drug: Liposomal bupivacaine
Popliteal nerve block
Other Names:
  • Exparel

    		•
    Active Comparator: Continuous perineural popliteal nerve block catheter

    Placement of continuous perineural popliteal nerve block catheter with injection of 30cc 0.5% bupivacaine within one hour prior to surgery, followed by continuous infusion of 10cc 0.3% ropivacaine (current standard practice) for at least 72 hours following surgery. Saphenous single shot 20cc 0.2

    Drug: Bupivacaine Hydrochloride 0.5 % Injectable Solution
    Continuous nerve catheter
    Other Names:
  • conventional bupivacaine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. Opioid Consumption [72 hours post-operatively]

      Total amount of opioid medication given, in morphine milligram equivalents

    2. Post-operative Length of Stay [Measured from surgical stop time to discharge time, an average of 5 days.]

      Length of stay in hours

    3. 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)

    4. Phantom Limb Pain assessed using questions from the Trinity Amputation and Prosthesis Experiences Scales-Revised (TAPES-R) [30 days following surgery]

      Measured using questions 4 and 5 from Part II of the TAPES-R (scores can range from 0, no pain, to 22, severe pain)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Maine Medical Center Portland Maine United States 04102

    Sponsors and Collaborators

    • Ryan Mountjoy, MD
    • MaineHealth

    Investigators

    • Principal Investigator: Ryan Mountjoy, MD, MaineHealth

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ryan Mountjoy, MD, Director of Scarborough Surgical Center, Principal Investigator, MaineHealth
    ClinicalTrials.gov Identifier:
    NCT05140499
    Other Study ID Numbers:
    • 1807862-1
    First Posted:
    Dec 1, 2021
    Last Update Posted:
    Jul 6, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Pain, Postoperative
    Bupivacaine

    Study Results

    No Results Posted as of Jul 6, 2022