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Postoperative Pain in Total Knee Arthroplasty: a Comparison Between General and Spinal Anesthesia

Primary Purpose

Total Knee Replacement Surgery

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Spinal Block
General anesthetic
Total knee replacement
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Total Knee Replacement Surgery

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • all patient who will undergo total knee arthroplasty

Exclusion Criteria:

  • patients who will not agree to participate in the study
  • patients who will die during the research timeframe

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Spinal block

    General anesthesia

    Arm Description

    Intrathecal 10 mg Heavy Marcaine, 200 mcg Morphine + High volume local anesthesia infiltration Bupivacaine 5mg/ml + adrenaline 5 mcg/ml 3mg/kg ideal body weight diluted with 100cc Normal Saline + Total Knee Replacement ( which will not be the intervention of interest)

    1-3 mg IV propofol 0.5 mg/kg IV Rocuronium + Fentanyl 2-3 mcg/kg + Morphine 0.1mg/kg IV Maintenance: Volatile anesthetic + High volume local anesthesia infiltration Bupivacaine 5mg/ml + adrenaline 5 mcg/ml 3mg/kg ideal body weight diluted with 100cc Normal Saline + Total Knee Replacement ( which will not be the intervention of interest)

    Outcomes

    Primary Outcome Measures

    postoperative pain measured by Visual Analogue Scale
    Visual Analogue Scale scores of pain will be documented at different timed during the first 48 postoperative hours

    Secondary Outcome Measures

    Achievements in physical therapy measured by walking distance on the first postoperative day
    The patient will walk with a walker under the surgeon's supervision, and the surgeon will measure with the distance the succeeded walking

    Full Information

    First Posted
    May 21, 2017
    Last Updated
    June 2, 2017
    Sponsor
    Meir Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03176758
    Brief Title
    Postoperative Pain in Total Knee Arthroplasty: a Comparison Between General and Spinal Anesthesia
    Official Title
    Postoperative Pain in Total Knee Arthroplasty: a Comparison Between General and Spinal Anesthesia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 1, 2017 (Anticipated)
    Primary Completion Date
    June 1, 2018 (Anticipated)
    Study Completion Date
    June 1, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Meir Medical Center

    4. Oversight

    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.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Total knee arthroplasty may be conducted either under general anesthesia or spinal block. previous studies have shown that spinal block leads to less complications. The investigators aim to find whether post-operative pain is also diminished under spinal block compared to general anesthesia
    Detailed Description
    Patients who will be registered for a total knee replacement in Meir Medical Center and that will agree to participate in the study will be enrolled into one of two groups: the first, which will be the default choice for all patients, will be operated under a spinal block. Patients who will ask specifically for general anesthesia, or those in which the anesthesiologist will prefer general anesthesia due to medical reasons will be enrolled into the second group. For both groups the surgeon will add intraoperative peri-articular infiltration of local Marcaine injections, which was previously shown to diminish postoperative pain. The postoperative pain will be evaluated with the Visual Analogue Scale at different point during the first 48 hours following operation. Physiotherapy achievements will also be recorded. The investigators will try to find whether one of the two groups suffered less pain or had achieved better results in physical therapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Total Knee Replacement Surgery

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    The participant will be non-randomly enrolled into two groups. The default treatment, which was found as the preferred method by numerous investigators will be offered to all participants. Those who will ask for the second option (general anesthesia) or those who will not be aligble for spinlal block will be enrolled in the second group.
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Spinal block
    Arm Type
    Active Comparator
    Arm Description
    Intrathecal 10 mg Heavy Marcaine, 200 mcg Morphine + High volume local anesthesia infiltration Bupivacaine 5mg/ml + adrenaline 5 mcg/ml 3mg/kg ideal body weight diluted with 100cc Normal Saline + Total Knee Replacement ( which will not be the intervention of interest)
    Arm Title
    General anesthesia
    Arm Type
    Active Comparator
    Arm Description
    1-3 mg IV propofol 0.5 mg/kg IV Rocuronium + Fentanyl 2-3 mcg/kg + Morphine 0.1mg/kg IV Maintenance: Volatile anesthetic + High volume local anesthesia infiltration Bupivacaine 5mg/ml + adrenaline 5 mcg/ml 3mg/kg ideal body weight diluted with 100cc Normal Saline + Total Knee Replacement ( which will not be the intervention of interest)
    Intervention Type
    Drug
    Intervention Name(s)
    Spinal Block
    Other Intervention Name(s)
    Neurological block
    Intervention Description
    Intrathecal 10 mg Heavy Marcaine, 200 mcg Morphine + High volume local anesthesia infiltration Bupivacaine 5mg/ml + adrenaline 5 mcg/ml 3mg/kg IBW diluted with 100cc Normal Saline
    Intervention Type
    Drug
    Intervention Name(s)
    General anesthetic
    Intervention Description
    1-3 mg IV propofol 0.5 mg/kg IV Rocuronium + Fentanyl 2-3 mcg/kg + Morphine 0.1mg/kg IV Maintenance: Volatile anesthetic + High volume local anesthesia infiltration Bupivacaine 5mg/ml + adrenaline 5 mcg/ml 3mg/kg IBW diluted with 100cc Normal Saline
    Intervention Type
    Device
    Intervention Name(s)
    Total knee replacement
    Intervention Description
    A total knee arthroplasty surgery, which is not the intervention of interest
    Primary Outcome Measure Information:
    Title
    postoperative pain measured by Visual Analogue Scale
    Description
    Visual Analogue Scale scores of pain will be documented at different timed during the first 48 postoperative hours
    Time Frame
    48 hours
    Secondary Outcome Measure Information:
    Title
    Achievements in physical therapy measured by walking distance on the first postoperative day
    Description
    The patient will walk with a walker under the surgeon's supervision, and the surgeon will measure with the distance the succeeded walking
    Time Frame
    24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: all patient who will undergo total knee arthroplasty Exclusion Criteria: patients who will not agree to participate in the study patients who will die during the research timeframe
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    david segal, MD
    Phone
    529423951
    Email
    dudisegal@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Participant's data will be collectively statistically analyzed, The results will be available as part of the researches findings while the participant's information will not be shared.
    Citations:
    PubMed Identifier
    28331362
    Citation
    Turnbull ZA, Sastow D, Giambrone GP, Tedore T. Anesthesia for the patient undergoing total knee replacement: current status and future prospects. Local Reg Anesth. 2017 Mar 8;10:1-7. doi: 10.2147/LRA.S101373. eCollection 2017.
    Results Reference
    background
    PubMed Identifier
    23788068
    Citation
    Kwofie MK, Shastri UD, Gadsden JC, Sinha SK, Abrams JH, Xu D, Salviz EA. The effects of ultrasound-guided adductor canal block versus femoral nerve block on quadriceps strength and fall risk: a blinded, randomized trial of volunteers. Reg Anesth Pain Med. 2013 Jul-Aug;38(4):321-5. doi: 10.1097/AAP.0b013e318295df80.
    Results Reference
    background
    PubMed Identifier
    19916251
    Citation
    Manickam B, Perlas A, Duggan E, Brull R, Chan VW, Ramlogan R. Feasibility and efficacy of ultrasound-guided block of the saphenous nerve in the adductor canal. Reg Anesth Pain Med. 2009 Nov-Dec;34(6):578-80. doi: 10.1097/aap.0b013e3181bfbf84.
    Results Reference
    background
    PubMed Identifier
    19130163
    Citation
    Macfarlane AJ, Prasad GA, Chan VW, Brull R. Does regional anesthesia improve outcome after total knee arthroplasty? Clin Orthop Relat Res. 2009 Sep;467(9):2379-402. doi: 10.1007/s11999-008-0666-9. Epub 2009 Jan 7.
    Results Reference
    background
    PubMed Identifier
    16651569
    Citation
    Busch CA, Shore BJ, Bhandari R, Ganapathy S, MacDonald SJ, Bourne RB, Rorabeck CH, McCalden RW. Efficacy of periarticular multimodal drug injection in total knee arthroplasty. A randomized trial. J Bone Joint Surg Am. 2006 May;88(5):959-63. doi: 10.2106/JBJS.E.00344.
    Results Reference
    background
    PubMed Identifier
    23612126
    Citation
    Memtsoudis SG, Sun X, Chiu YL, Stundner O, Liu SS, Banerjee S, Mazumdar M, Sharrock NE. Perioperative comparative effectiveness of anesthetic technique in orthopedic patients. Anesthesiology. 2013 May;118(5):1046-58. doi: 10.1097/ALN.0b013e318286061d. Erratum In: Anesthesiology. 2016 Sep;125(3):610.
    Results Reference
    background

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    Postoperative Pain in Total Knee Arthroplasty: a Comparison Between General and Spinal Anesthesia

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