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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05144425
Enrollment
100
Registered
2021-12-03
Start date
2021-12-10
Completion date
2022-12-31
Last updated
2021-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Blood Loss

Keywords

total knee arthroplasty

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

Interventions

PROCEDUREtotal 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.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
55 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
amount of perioperative blood loss in ml with and without using tourniquet during TKA48hrTotal 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

MeasureTime frameDescription
post operative pain measured on VAS after TKA with and without using tourniquet48hrKnee 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 TKAoperation timeoperative time in minutes will be calculated and compared the two groups
hemoglobin level in gm/dl preoperative and postoperative48hrsHemoglobin 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.

Contacts

Primary ContactMohamed Elbasel Abdel Raheem, Bachelor
dmbheba21@gmail.com01091673453
Backup ContactYasser Emam Mohamed, MD
YKhalifa67@yahoo.com01005673622

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026