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
About this trial
This is an interventional treatment trial for Total Blood Loss focused on measuring total knee arthroplasty
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
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
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
background
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
background
Learn more about this trial
Evaluation of Blood Loss and Pain in TKA With and Without Pneumatic Tourniquet, A Randomized Controlled Trial
We'll reach out to this number within 24 hrs