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

Not Applicable

• Conditions: Total Blood Loss
• Interventions: Procedure: total knee arthroplasty with and without using pneumatic tourniquet

• Registration Number: NCT05144425
• Lead Sponsor: Assiut University

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

Study Timeline

• Status Verified: 2021-11
• Study First Submitted: 2021-11-22
• Study First Submitted QC: 2021-11-22
• Last Update Submitted: 2021-11-22
• Study First Posted: 2021-12-03
• Last Update Posted: 2021-12-03
• Study Start: 2021-12-10
• Primary Completion: 2022-10
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group A	total knee arthroplasty with and without using pneumatic tourniquet	underwent TKA with using pneumatic tourniquet
group B	total knee arthroplasty with and without using pneumatic tourniquet	underwent TKA without using pneumatic tourniquet

Primary Outcome Measures

Name	Time	Method
amount of perioperative blood loss in ml with and without using tourniquet during TKA	48hr	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

Name	Time	Method
post operative pain measured on VAS after TKA with and without using tourniquet	48hr	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	operation time	operative time in minutes will be calculated and compared the two groups
hemoglobin level in gm/dl preoperative and postoperative	48hrs	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.