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3 Local Anesthetics for Spinal Anesthesia in Primary Total Hip Arthroplasty

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ClinicalTrials.gov Identifier: NCT03948386
Recruitment Status : Recruiting
First Posted : May 13, 2019
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University

Brief Summary:
Spinal anesthesia is commonly utilized for hip replacement surgery. Different medications used for spinal anesthesia work for different lengths of time. This study will compare three different spinal anesthesia medications in patients having hip replacement surgery to see if patients are able to get out of bed and walk earlier after surgery with one medication versus the others.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Hip Drug: isobaric bupivacaine Drug: hyperbaric bupivacaine Drug: isobaric mepivacaine Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Patients who agree to participate will then be randomized by a computer-generated sequence to one of the three study groups.

Dosing will be as follows: isobaric bupivacaine 12.5 mg (2.5 cc of 0.5%) for ≤ 74" height and 15 mg (3 cc) for > 74" height; hyperbaric bupivacaine 10.25 mg (1.5 cc 0.75%) for ≤ 74" height and 13.125 mg (1.75 cc) for > 74" height; and isobaric mepivacaine 52.5 mg (3.5 cc of 1.5%) for ≤ 74" height and 60 mg (4 cc) for > 74" height.

Masking: Double (Participant, Outcomes Assessor)
Masking Description:

The anesthesiologist and certified registered nurse anesthetist or resident performing the spinal will be aware of group allocation and will perform spinal anesthesia according to standard operating procedures with the assigned local anesthetic.

Patients will remain blinded and surgeons and those performing postoperative assessments will remain blinded as well.

Primary Purpose: Treatment
Official Title: A Randomized, Controlled, Double-Blind Trial of 3 Local Anesthetics for Spinal Anesthesia in Primary Total Hip Arthroplasty to Compare the Percentage of Patients in Each Group With Early Ambulation
Actual Study Start Date : May 13, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: isobaric bupivacaine
Isobaric bupivacaine 12.5 mg (2.5 cc of 0.5%) for ≤ 74" height and 15 mg (3 cc) for > 74" height
Drug: isobaric bupivacaine
The anesthesiologist and CRNA or resident performing the spinal will perform spinal anesthesia according to standard operating procedures with the randomly assigned local anesthetic.

Active Comparator: hyperbaric bupivacaine
hyperbaric bupivacaine 10.25 mg (1.5 cc 0.75%) for ≤ 74" height and 13.125 mg (1.75 cc) for > 74" height
Drug: hyperbaric bupivacaine
TThe anesthesiologist and CRNA or resident performing the spinal will perform spinal anesthesia according to standard operating procedures with the randomly assigned local anesthetic.

Active Comparator: isobaric mepivacaine
isobaric mepivacaine 52.5 mg (3.5 cc of 1.5%) for ≤ 74" height and 60 mg (4 cc) for > 74" height
Drug: isobaric mepivacaine
The anesthesiologist and CRNA or resident performing the spinal will perform spinal anesthesia according to standard operating procedures with the randomly assigned local anesthetic.




Primary Outcome Measures :
  1. Percentage ambulating early after spinal anesthesia [ Time Frame: 3.5 hours ]
    Is there a difference between isobaric mepivacaine, hyperbaric bupivacaine, and isobaric bupivacaine when used for spinal anesthesia in primary total hip replacement in percentage of patients that can ambulate within 3.5 hours after spinal anesthesia.


Secondary Outcome Measures :
  1. return of motor function of the thigh and lower leg [ Time Frame: Postoperative day 0 (day of surgery) ]
    time to return of motor function of the thigh and lower leg

  2. return of sensory function of the thigh and lower leg [ Time Frame: Postoperative day 0 (day of surgery) ]
    time to return of sensory function of the thigh and lower leg

  3. incidence of orthostatic hypotension [ Time Frame: Postoperative day 2 ]
    incidence of low blood pressure when transitioning from lying down to sitting or standing

  4. incidence of dizziness [ Time Frame: Postoperative day 2 ]
    incidence of dizziness when transitioning from lying down to sitting or standing

  5. incidence of urinary retention [ Time Frame: postoperative day 1 ]
    incidence of patients with inability to urinate within 8 hours of surgery OR a report of distended or painful bladder occurring on postoperative day 0 or 1, either by patient report or on palpation by nursing

  6. transient neurological symptoms (TNS) [ Time Frame: Postoperative day 2 ]
    incidence of TNS

  7. hospital stay [ Time Frame: 0-30 days after surgery ]
    length of hospital stay

  8. Percentage of Patients in Each Group Meeting Discharge Readiness Criteria [ Time Frame: 0-30 days after surgery ]
    The percentage of patients in each group that meets discharge readiness criteria will be compared.



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Ages Eligible for Study:   18 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • undergoing elective primary hip replacement surgery
  • American Society of Anesthesiologists physical status 1-3

Exclusion Criteria:

  • hip fracture
  • contraindication to spinal anesthesia (refusal, coagulopathy or recent use of anticoagulant medication that prevents spinal anesthesia, local or systemic infection)
  • any other reason deemed significant by attending anesthesiologist
  • any patient requiring a wheelchair for ambulation or who cannot walk 25 feet with or without an assist device at time of surgery
  • presence of neuropathy in posterior thighs or buttocks
  • use of greater than the equivalent of morphine 25 mg IV (oxycodone 30 mg PO) daily
  • any patient deemed a poor candidate for spinal anesthesia as determined by the attending anesthesiologist

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): NCT03948386


Contacts
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Contact: Eric Schwenk, MD 215-955-6161 eric.schwenk@jefferson.edu
Contact: Jennifer Lessin, BA, RN 215-955-5804 jennifer.lessin@jefferson.edu

Locations
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United States, Pennsylvania
Rothman Orthopedic Specialty Hospital Recruiting
Bensalem, Pennsylvania, United States, 19020
Contact: Vincent Kasper, MD    215-803-7878    vincent.kasper@gmail.com   
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Eric Schwenk, MD    215-955-6161    Eric.Schwenk@jefferson.edu   
Contact: Jennifer Lessin, RN    215-955-5804    Jennifer.Lessin@jefferson.edu   
Sub-Investigator: Jaime Baratta, MD         
Sponsors and Collaborators
Thomas Jefferson University
Investigators
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Principal Investigator: Eric Schwenk, MD Thomas Jefferson University

Publications:

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Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT03948386     History of Changes
Other Study ID Numbers: 19D.299
First Posted: May 13, 2019    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019

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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:
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Osteoarthritis, Hip
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Anesthetics
Bupivacaine
Mepivacaine
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents