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

Assiut University

Status: Unknown

Conditions: Total Blood Loss

Treatments: Procedure: total knee arthroplasty with and without using pneumatic tourniquet

Study type: Interventional

Funder types: Other

Identifiers

NCT05144425

Elbasel

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 55 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

group A

Active Comparator group

Description:

underwent TKA with using pneumatic tourniquet

Treatment:

Procedure: total knee arthroplasty with and without using pneumatic tourniquet

group B

Placebo Comparator group

Description:

underwent TKA without using pneumatic tourniquet

Treatment:

Procedure: total knee arthroplasty with and without using pneumatic tourniquet