Clinical trial NCT05144425: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Total Blood Loss
Keywords: total knee arthroplasty
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-12-03
Enrollment: 100
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: amount of perioperative blood loss in ml with and without using tourniquet during TKA
timeFrame: 48hr
Secondary outcomes:
measure: post operative pain measured on VAS after TKA with and without using tourniquet
timeFrame: 48hr
measure: operative time in minutes with and without using tourniquet in TKA
timeFrame: operation time
measure: hemoglobin level in gm/dl preoperative and postoperative
timeFrame: 48hrs
Other outcomes:
Locations:
Study officials:
affiliation: staff member at assuit university faculty of medicine orthopedic department
name: Mohamed Ahmed Mahran, MD
role: STUDY_CHAIR
References:
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.
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.
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.