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Evaluation of Blood Loss and Pain in TKA With and Without Pneumatic Tourniquet, A Randomized Controlled Trial

Primary Purpose

Total Blood Loss

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
total knee arthroplasty with and without using pneumatic tourniquet
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Total Blood Loss focused on measuring total knee arthroplasty

Eligibility Criteria

55 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • any patient with knee osteoarthritis undergoing primary total knee arthroplasty

Exclusion Criteria:

  1. patients with hemorrhagic disease
  2. patient with revision total knee arthroplasty
  3. patient with history of vascular thrombosis
  4. patients taking anti-platelet agents due to cardiovascular disease
  5. patients with hemoglobin level below 10gm/dl

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    group A

    group B

    Arm Description

    underwent TKA with using pneumatic tourniquet

    underwent TKA without using pneumatic tourniquet

    Outcomes

    Primary Outcome Measures

    amount of perioperative blood loss in ml with and without using tourniquet during TKA
    Total measured blood loss will be calculated as the volume of the intraoperative blood loss plus the volume of postoperative visible blood loss from the hemovac drains and will be expressed as mL

    Secondary Outcome Measures

    post operative pain measured on VAS after TKA with and without using tourniquet
    Knee joint pain will be measured on a visual analog scale (VAS) (range, 0-10) pre-operatively and on the 3rd, 5th, 7th and 14th postoperative days [12]. A higher score on the VAS equates to a higher level of pain.
    operative time in minutes with and without using tourniquet in TKA
    operative time in minutes will be calculated and compared the two groups
    hemoglobin level in gm/dl preoperative and postoperative
    Hemoglobin level will be measured pre-operatively and after 24hrs and 48 hrs post-operatively. Patients with Hb < 8 g/dl or those who have exhibited symptoms of acute anemia will receive blood transfusion therapy. The amount of blood transfused will be recorded.

    Full Information

    First Posted
    November 22, 2021
    Last Updated
    November 22, 2021
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05144425
    Brief Title
    Evaluation of Blood Loss and Pain in TKA With and Without Pneumatic Tourniquet, A Randomized Controlled Trial
    Official Title
    Evaluation of Blood Loss and Pain in TKA With and Without Pneumatic Tourniquet, A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 10, 2021 (Anticipated)
    Primary Completion Date
    October 2022 (Anticipated)
    Study Completion Date
    December 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The aim of our study is to determine whether the use of a tourniquet during TKA would affect total measured blood loss , operation time, postoperative complications; hemoglobin concentration; limb swelling and postoperative pain.
    Detailed Description
    Tourniquets are widely used in total knee arthroplasty (TKA) . TKA has been reported to be associated with significant blood loss which at times necessitates transfusion. Although the tourniquet is widely used by orthopedic surgeons, its role is controversial . Several studies have shown that using a tourniquet in TKA could reduce the total blood loss, while results from others indicated the opposite . Therefore the relationship between the use of a tourniquet and the total blood loss of patients undergoing TKA is still unclear. The use of a tourniquet is believed to be effective for decreasing intraoperative blood loss and creating a bloodless surgical field, which theoretically would facilitate the cementing technique and other surgical procedures. However, reactive blood flow reaches its peak within five minutes after the tourniquet has been released Complications reported as a consequence of tourniquet application are skin injury [skin abrasions, blisters, breaks , pressure necrosis], nerve injury, post tourniquet syndrome, Deep venous thrombosis, Postoperative pain, wound healing disorders and early infections

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Total Blood Loss
    Keywords
    total knee arthroplasty

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    group A
    Arm Type
    Active Comparator
    Arm Description
    underwent TKA with using pneumatic tourniquet
    Arm Title
    group B
    Arm Type
    Placebo Comparator
    Arm Description
    underwent TKA without using pneumatic tourniquet
    Intervention Type
    Procedure
    Intervention Name(s)
    total knee arthroplasty with and without using pneumatic tourniquet
    Intervention Description
    The randomization will be performed by a research fellow who will not be involved in patient care. All of the operations will be performed through the medial parapatellar approach by experienced knee surgeons. Drainage system will be used for 48 hours postoperative. In the tourniquet group, the tourniquet will be inflated to a pressure of systolic blood pressure plus 100 mm Hg and will be released after the joint capsule has been closed. hemostasis and then will be wrapped with elastic bandages. In the non-tourniquet group, the tourniquet will be wrapped around the thigh but will not be inflated during the surgery. The criterion for a blood transfusion will set as a hemoglobin (Hb) level of<8 g/dL or patient with symptomatic anemia.
    Primary Outcome Measure Information:
    Title
    amount of perioperative blood loss in ml with and without using tourniquet during TKA
    Description
    Total measured blood loss will be calculated as the volume of the intraoperative blood loss plus the volume of postoperative visible blood loss from the hemovac drains and will be expressed as mL
    Time Frame
    48hr
    Secondary Outcome Measure Information:
    Title
    post operative pain measured on VAS after TKA with and without using tourniquet
    Description
    Knee joint pain will be measured on a visual analog scale (VAS) (range, 0-10) pre-operatively and on the 3rd, 5th, 7th and 14th postoperative days [12]. A higher score on the VAS equates to a higher level of pain.
    Time Frame
    48hr
    Title
    operative time in minutes with and without using tourniquet in TKA
    Description
    operative time in minutes will be calculated and compared the two groups
    Time Frame
    operation time
    Title
    hemoglobin level in gm/dl preoperative and postoperative
    Description
    Hemoglobin level will be measured pre-operatively and after 24hrs and 48 hrs post-operatively. Patients with Hb < 8 g/dl or those who have exhibited symptoms of acute anemia will receive blood transfusion therapy. The amount of blood transfused will be recorded.
    Time Frame
    48hrs

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    55 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: any patient with knee osteoarthritis undergoing primary total knee arthroplasty Exclusion Criteria: patients with hemorrhagic disease patient with revision total knee arthroplasty patient with history of vascular thrombosis patients taking anti-platelet agents due to cardiovascular disease patients with hemoglobin level below 10gm/dl
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohamed Elbasel Abdel Raheem, Bachelor
    Phone
    01091673453
    Email
    dmbheba21@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yasser Emam Mohamed, MD
    Phone
    01005673622
    Email
    YKhalifa67@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mohamed Ahmed Mahran, MD
    Organizational Affiliation
    staff member at assuit university faculty of medicine orthopedic department
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    30822788
    Citation
    Arthur JR, Spangehl MJ. Tourniquet Use in Total Knee Arthroplasty. J Knee Surg. 2019 Aug;32(8):719-729. doi: 10.1055/s-0039-1681035. Epub 2019 Mar 1.
    Results Reference
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    PubMed Identifier
    31282982
    Citation
    Nicolaiciuc S, Probst P, von Eisenhart-Rothe R, Burgkart R, Hube R. Modern Total Knee Arthroplasty (TKA): With Or Without a Tourniquet? Surg Technol Int. 2019 Nov 10;35:336-340.
    Results Reference
    background
    PubMed Identifier
    31703706
    Citation
    Cai DF, Fan QH, Zhong HH, Peng S, Song H. The effects of tourniquet use on blood loss in primary total knee arthroplasty for patients with osteoarthritis: a meta-analysis. J Orthop Surg Res. 2019 Nov 8;14(1):348. doi: 10.1186/s13018-019-1422-4.
    Results Reference
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    Evaluation of Blood Loss and Pain in TKA With and Without Pneumatic Tourniquet, A Randomized Controlled Trial

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