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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Total Blood Loss
• Intervention / Treatment: Procedure: total knee arthroplasty with and without using pneumatic tourniquet

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

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed Elbasel Abdel Raheem, Bachelor; Phone Number: 01091673453; Email: dmbheba21@gmail.com
• Study Contact Backup: Name: Yasser Emam Mohamed, MD; Phone Number: 01005673622; Email: YKhalifa67@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group A; underwent TKA with using pneumatic tourniquet	Procedure: total knee arthroplasty with and without using pneumatic tourniquet; 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.
Placebo Comparator: group B; underwent TKA without using pneumatic tourniquet	Procedure: total knee arthroplasty with and without using pneumatic tourniquet; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	48hr

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	48hr
operative time in minutes with and without using tourniquet in TKA	operative time in minutes will be calculated and compared the two groups	operation time
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.	48hrs

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Chair: Mohamed Ahmed Mahran, MD, staff member at assuit university faculty of medicine orthopedic department

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 10, 2021
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: November 22, 2021
• First Submitted That Met QC Criteria: November 22, 2021
• First Posted (Actual): December 3, 2021

Study Record Updates

• Last Update Posted (Actual): December 3, 2021
• Last Update Submitted That Met QC Criteria: November 22, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: total knee arthroplasty
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Exsanguination
• Other Study ID Numbers: Elbasel

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No