We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Liposomal Bupivacaine vs Continuous Nerve Catheters for Below the Knee Amputations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05140499
Recruitment Status : Recruiting
First Posted : December 1, 2021
Last Update Posted : September 1, 2022
Sponsor:
Collaborator:
MaineHealth
Information provided by (Responsible Party):
Ryan Mountjoy, MD, MaineHealth

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
Pain, Postoperative Amputation 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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
Actual Study Start Date : August 15, 2022
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : January 31, 2023

Resource links provided by the National Library of Medicine


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 Name: 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 Name: conventional bupivacaine




Primary Outcome Measures :
  1. Pain assessed by Numerical Rating Scale (NRS) [ Time Frame: 72 hours post-operatively ]
    Average NRS pain scores (0-10, 0=no pain, 10=worst possible pain)


Secondary Outcome Measures :
  1. Opioid Consumption [ Time Frame: 72 hours post-operatively ]
    Total amount of opioid medication given, in morphine milligram equivalents

  2. Post-operative Length of Stay [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05140499


Contacts
Layout table for location contacts
Contact: Janelle M Richard 2076622862 richaj3@mmc.org

Locations
Layout table for location information
United States, Maine
Maine Medical Center Recruiting
Portland, Maine, United States, 04102
Contact: Janelle Richard    207-662-2862    richaj3@mmc.org   
Principal Investigator: Ryan Mountjoy, MD         
Sponsors and Collaborators
Ryan Mountjoy, MD
MaineHealth
Investigators
Layout table for investigator information
Principal Investigator: Ryan Mountjoy, MD MaineHealth
Publications:
Neil MJE. Pain after amputation. BJA Education. 2016: 16(3):107-12.
Gallagher P, MacLachlan M. Development and psychometric evaluation of the Trinity Amputation and Prosthesis Experience Scales (TAPES). Rehabilitation Psychology. 2000: 45(2), 130-154.
Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics. 2005;4(4):287-91.

Layout table for additonal information
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: December 1, 2021    Key Record Dates
Last Update Posted: September 1, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents