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

NCT05144425 | Unknown

• 1 other identifier: Elbasel
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Total Blood Loss

Keywords

total knee arthroplasty

Outcome Measures

Primary Outcomes (1)

• amount of perioperative blood loss in ml with and without using tourniquet during TKA

  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

  48hr

Secondary Outcomes (3)

• post operative pain measured on VAS after TKA with and without using tourniquet

  48hr

• operative time in minutes with and without using tourniquet in TKA

  operation time

• hemoglobin level in gm/dl preoperative and postoperative

  48hrs

Study Arms (2)

group A

ACTIVE COMPARATOR

underwent TKA with using pneumatic tourniquet

Procedure: total knee arthroplasty with and without using pneumatic tourniquet

group B

PLACEBO COMPARATOR

underwent TKA without using pneumatic tourniquet

Procedure: total knee arthroplasty with and without using pneumatic tourniquet

Interventions

total knee arthroplasty with and without using pneumatic tourniquet PROCEDURE

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.

group A; group B

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• any patient with knee osteoarthritis undergoing primary total knee arthroplasty

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (3)

• 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.

  PMID: 30822788 BACKGROUND

• 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.

  PMID: 31282982 BACKGROUND

• 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.

  PMID: 31703706 BACKGROUND

MeSH Terms

Conditions

Exsanguination

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Mohamed Ahmed Mahran, MD

  staff member at assuit university faculty of medicine orthopedic department

  STUDY CHAIR

Central Study Contacts

Mohamed Elbasel Abdel Raheem, Bachelor

CONTACT

01091673453; dmbheba21@gmail.com

Yasser Emam Mohamed, MD

CONTACT

01005673622; YKhalifa67@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assiut medical school ethical review board [assiut]

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: December 3, 2021
• Study Start: December 10, 2021
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: December 3, 2021

Record last verified: 2021-11