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Peripheral Nerve Blocks for Above-the-knee Amputations

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ClinicalTrials.gov Identifier: NCT03404180
Recruitment Status : Recruiting
First Posted : January 19, 2018
Last Update Posted : July 24, 2019
Sponsor:
Collaborator:
US Department of Veterans Affairs
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE December 20, 2017
First Posted Date  ICMJE January 19, 2018
Last Update Posted Date July 24, 2019
Actual Study Start Date  ICMJE February 9, 2018
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2018)
  • Chi-squared tests of peripheral nerve block success as a primary anesthetic [ Time Frame: Changes from baseline through 30 days post-operative ]
    Differences in block success percentages analyzed between study participants.
  • Analysis of pain scores [ Time Frame: Changes from baseline through 48 hours post procedure. ]
    Numerical rating scale pain scores (0-10) will be obtained from patients upon arrival and recorded hourly until discharge. Patients will be called or visited 24-48 hours post procedure to inquire about patient satisfaction. Differences in study participant pain scores will be examined through t-tests. P < 0.05 will be considered statistically significant.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03404180 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2018)
Mortality [ Time Frame: Changes from baseline through 30 days post-operative ]
The medical record will be reviewed to assess 30-day mortality.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Peripheral Nerve Blocks for Above-the-knee Amputations
Official Title  ICMJE Peripheral Nerve Blocks for Upper Leg Amputations
Brief Summary Surgery performed with nerve blocks and sedation may be safer and provide better pain control compared to general anesthesia and opioid therapy in high-risk patient populations such as elderly and troubled with peripheral vascular disease, diabetes, hypertension, coronary artery disease, and chronic obstructive pulmonary disease (COPD).
Detailed Description Avoidance of general anesthesia in certain high-risk patient populations may have additional benefits beyond improved postoperative pain scores and analgesic consumption. The primary objective of this research will be to evaluate the ability of the femoral, sciatic, lateral femoral cutaneous nerve (LFCN), and obturator blocks to provide surgical anesthesia.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Pilot clinical trial with a single arm
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Peripheral Vascular Diseases
  • Hyperglycaemia (Diabetic)
  • Hypertension
  • Coronary Artery Disease
  • Pulmonary Disease, Chronic Obstructive
Intervention  ICMJE
  • Procedure: Peripheral nerve block
    All enrollees will have ultrasound-guided femoral and sciatic nerve blocks placed per current practice at research site. Single-injection obturator and lateral femoral cutaneous nerve blocks will also be performed.
  • Drug: Intravenous Sedatives
    Intravenous sedation using propofol or dexmedetomidine will be administered.
    Other Name: Propofol or Dexmedetomidine
  • Procedure: Lateral femoral cutaneous nerve blocks
    After administration of intravenous sedation, lateral femoral cutaneous and obturator nerve blocks (in addition to the femoral and sciatic catheters) will be performed under ultrasound guidance.
  • Procedure: Obturator nerve blocks
    After administration of intravenous sedation, lateral femoral cutaneous and obturator nerve blocks (in addition to the femoral and sciatic catheters) will be performed under ultrasound guidance.
Study Arms  ICMJE Experimental: Peripheral nerve block

Prospectively evaluate peripheral nerve blocks as a primary anesthetic in the setting of above-the-knee amputations.

All enrollees will be administered Intravenous sedatives using propofol or dexmedetomidine and have ultrasound-guided femoral and sciatic nerve blocks placed per current practice at research site. Single-injection obturator nerve blocks and lateral femoral cutaneous nerve blocks will also be performed.

Interventions:
  • Procedure: Peripheral nerve block
  • Drug: Intravenous Sedatives
  • Procedure: Lateral femoral cutaneous nerve blocks
  • Procedure: Obturator nerve blocks
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 11, 2018)
36
Original Estimated Enrollment  ICMJE
 (submitted: January 11, 2018)
30
Estimated Study Completion Date  ICMJE May 2020
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients undergoing above-the-knee amputation or knee disarticulation
  • Ability to understand and provide informed consent

Exclusion Criteria:

  • Patient refusal or inability to provide informed consent
  • True allergy, not sensitivity, to any of the following substances:
  • - Local anesthetics
  • - Propofol or other sedative agents
  • - General anesthetic agents
  • Pregnancy
  • Severe hepatic impairment
  • Evidence of infection at or near the proposed needle insertion site
  • Any sensorimotor deficit, whether acute or chronic, as determined by the PI
  • Chronic use of opioid medication
  • BMI ≥ 35
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Amy M. Gunnett, RN, CCRC 352-273-8911 agunnett@anest.ufl.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03404180
Other Study ID Numbers  ICMJE IRB201702402
OCR18952 ( Other Identifier: University of Florida )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE US Department of Veterans Affairs
Investigators  ICMJE
Principal Investigator: José R Soberón, MD Malcom Randall VA Medical Center
PRS Account University of Florida
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP