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NCT05144425 | Unknown status | Total Blood Loss


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

Assiut University

Information provided by (Responsible Party):

Muhammad Al-Basal Abdlerham

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.

Condition or disease

Total Blood Loss

Intervention/treatment

total knee arthroplasty with and without using pneumatic tourniquet

Phase

Not Applicable

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
Estimated Enrollment : 100 participants
Masking : Single
Primary Purpose : Treatment
Official Title : Evaluation of Blood Loss and Pain in TKA With and Without Pneumatic Tourniquet, A Randomized Controlled Trial
Actual Study Start Date : December 10, 2021
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : December 2022
Arm Intervention/treatment

Active Comparator: group A

underwent TKA with using pneumatic tourniquet

Procedure: total knee arthroplasty with and without using pneumatic tourniquet

Placebo Comparator: group B

underwent TKA without using pneumatic tourniquet

Procedure: total knee arthroplasty with and without using pneumatic tourniquet

Ages Eligible for Study: 55 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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

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

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

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