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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 : October 31, 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

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Detailed Description:

Total hip replacement is often performed under spinal anesthesia, which is the standard at Thomas Jefferson University Hospital (TJUH) and Rothman Orthopedic Specialty Hospital (ROSH) for patients without contraindications. Spinal anesthesia involves injecting a numbing medicine (local anesthetic) into the cerebrospinal fluid that bathes the spinal cord through a space between two bones in the back. This causes temporary numbness of the legs and hips and allows surgery to take place without patients feeling pain during surgery. Different local anesthetics can be used for spinal anesthesia and each works for a different duration of time. Another factor that affects how spinal anesthesia medications work is the baricity of the medication, which refers to how dense it is compared to cerebrospinal fluid (CSF). Medications that are less dense than CSF are hypobaric, those with same density are isobaric, and those with greater density are hyperbaric. For clinical purposes, this really only comes into play when positioning the patient immediately after spinal placement as patient position has different effects on the dermatomal level attained depending on baricity of the local anesthetic. Bupivacaine is a long-acting local anesthetic that has been used for several decades for total hip replacement. It is available in both hyperbaric form (with dextrose added) and isobaric form (with no dextrose added). Mepivacaine is another local anesthetic that has a shorter duration of action and is also used for spinal anesthesia in total hip replacement at many centers. All three drugs are used routinely at different centers in the United States. Despite the differences in duration that have been described from pharmacokinetic studies, a randomized, controlled study comparing the three drugs in terms of important outcomes, such as the ability to walk after surgery, has not been published yet. Therefore, the investigators want to compare the three local anesthetics in a randomized, controlled fashion to see if more patients are able to walk sooner after receiving mepivacaine spinal anesthesia than either form of bupivacaine spinal anesthesia.

Patients who are eligible will be called the night prior to surgery and the study will be explained over the phone. Patients who express interest will be recruited on the day of their scheduled surgery in the short-procedure unit. Patients will be given consent forms and time to read them and ask questions.

Preoperative Management All patients without contraindications or allergies will receive oral gabapentin and acetaminophen in the short procedure unit prior to surgery per routine practice.

Intraoperative Management The targeted spinal dermatome level to achieve will be T10 (umbilicus). For isobaric drugs, patients will sit after spinal placement for 3-5 minutes to achieve this level. For hyperbaric bupivacaine, patients will be immediately placed supine and in Trendelenberg position for 3-5 minutes to achieve adequate level and confirmed with sensory pinprick testing, which will be performed every 2 minutes beginning at spinal placement time. After spinal is placed, sedation will be titrated at the discretion of the anesthesia team to achieve the American Society of Anesthesiology's definition of moderate sedation (purposeful response to verbal or tactile stimulation, spontaneous ventilation, and no airway intervention needed) using propofol. All patients will receive tranexamic acid unless contraindicated (10 mg/kg bolus), as well as multimodal analgesia with a non-steroidal anti-inflammatory drug (NSAID) and dexamethasone 4 mg IV per routine practice.

Postoperative Management

Sensory and motor assessments will take place every 30 minutes from PACU arrival time until motor strength is 5/5 in both lower extremities in hip flexion, knee extension, and toe dorsiflexion or the patient's motor function returns to baseline. The time of return of motor function will be documented. Physical therapists will visit the patient between 3 and 3.5 hours after spinal placement to assess for ability to ambulate and perform Tinnetti test, which assesses ambulation and gait and gives a score of 0 through 28 (see attached). Urinary retention will be assessed through asking the following on postoperative day 1:

  1. At what time did the participant first urinate?
  2. Did participant require a Foley catheter or straight catheter to drain urine from his or her bladder?

These questions will be asked along with the following about TNS (transient neurological symptoms):

  1. Does the participant have any pain in his or her lower back that goes into his or her buttocks and/or down his or her thigh that was not there before surgery?
  2. If yes, how would the participant rate that specific pain from 0 (no pain) to 10 (worst pain imaginable).
  3. How would the participant rate his/her overall pain (0 to 10 scale)?
  4. How satisfied is the participant with his/her anesthesia experience (0 to 10 scale where 0 is very dissatisfied and 10 is very satisfied)?

TNS will be defined as the new onset (within 24 hours of surgery) of back pain that radiates into the buttocks, thighs, hips, or distally. Localized back pain will not be included.

Urinary retention will be defined by inability to urinate within 8 hours, a report of distended or painful bladder occurring on postoperative days 0 or 1, either by patient report or on assessment by nursing, or the use of a Foley catheter or straight catheter.

Post-discharge phone calls

The following will be asked to patients via phone calls after discharge at 24 and 48 hours after surgery if not still in the hospital (will be asked in-person otherwise):

  1. Does the participant have any back pain that was not present before surgery that goes into his/her buttocks, thighs, hips, or lower leg?
  2. If yes, how would the participant rate that specific pain from 0 (no pain) to 10 (worst pain imaginable).
  3. How would the participant rate his/her overall pain (0 to 10 scale)?
  4. How satisfied is the participant with his/her anesthesia experience (0 to 10 scale where 0 is very dissatisfied and 10 is very satisfied)?

Post-discharge data collection Readmissions within 90 days will be recorded for all patients including the reason for readmission.

General Operating Procedures Patients who agree to participate will then be randomized by a computer-generated sequence to one of the three study groups. 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. Intraoperative sedation will be with propofol or dexmedetomidine, at the discretion of the anesthesia team. Patients will remain blinded and surgeons and those performing postoperative assessments will remain blinded as well. As all study drugs are standard spinal anesthesia drugs and readily available, the anesthesia team caring for the patient will be informed of group allocation and the appropriate drug will be selected. These doses of hyperbaric and isobaric bupivacaine are considered "low dose" and are lower than those routinely used at TJUH and ROSH. However, existing evidence shows that low-dose bupivacaine for spinal anesthesia provides adequate anesthesia time for a total joint replacement. 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 > or = 74" height; hyperbaric bupivacaine 10.25 mg (1.5 cc 0.75%) for < 74" height and 13.125 mg (1.75 cc) for > or = 74" height; and isobaric mepivacaine 52.5 mg (3.5 cc of 1.5%) for < 74" height and 60 mg (4 cc) for > or = 74" height. Patients with BMI of 35 or greater will also be given the higher dose of each of the 3 medications listed above.

Intraoperative variables that will be measured include: hypotension (defined as a decrease in baseline blood pressure of 20% or greater), surgeon rating of intraoperative muscle tension (0, 1, 2, or 3 where 0 is the most relaxed and 3 is the tightest), and conversion to general anesthesia.

Postoperative variables that will be measured include: ambulation at 3-3.5 hours (primary endpoint), time to ambulation, attempts needed to ambulate, episodes of orthostatic hypotension while trying to ambulate, urinary retention, opioid consumption, pain, incidence of transient neurological symptoms up to 48 hours postoperatively, discharge readiness, and length of stay.

Post-discharge phone calls

The following will be asked to patients via phone calls after discharge on postoperative days 1 and 2 after surgery if not still in the hospital (will be asked in-person otherwise):

  1. Does the participant have any pain in his/her lower back that goes into his/her buttocks and/or down his/her thigh that was not there before surgery?
  2. If yes, how would the participant rate that specific pain from 0 (no pain) to 10 (worst pain imaginable).
  3. How would the participant rate his/her overall pain (0 to 10 scale)?
  4. How satisfied is the participant with his/her anesthesia experience (0 to 10 scale where 0 is very dissatisfied and 10 is very satisfied)?

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 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.



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.


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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: October 31, 2019
Last Verified: October 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