After Surgery Acute Renal Failure Incidence in Total Knee Arthroplasty With and Without Tourniquet

NCT03795805 | Completed

• 1 other identifier: R-2018-3401-053
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study analize the incidence of acute renal failure after performing total knee arthroplasty with or without use of tourniquet limb cuff (half of patients for each group) in a randomized clinical trial

Conditions

Arthroplasty, Replacement, Knee; Acute Kidney Injury; Tourniquets; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (3)

• Creatinin before surgery

  Blood Creatinin meassure in mg/dl before surgery

  Creatinin before surgery

• Creatinin after surgery 1

  Blood Creatinin meassure in mg/dl at 24 hours

  Creatinin after surgery 1 at 24 hours

• Creatinin after surgery 2

  Blood Creatinin meassure in mg/dl at 48 hours

  Creatinin after surgery 2 at 48 hours

Study Arms (2)

TKA and Tourniquet

OTHER

Total knee arthroplasty and use of tourniquet limb cuff at 270 mmHg

Procedure: total knee arthroplasty; Procedure: Tourniquet limb cuff

Intraarticular lidocain

EXPERIMENTAL

Total knee arthroplasty with Intaarticular lidocain

Procedure: total knee arthroplasty; Drug: Intaarticular lidocain

Interventions

total knee arthroplasty PROCEDURE

Total knee arhroplasty

Also known as: TKA

Intraarticular lidocain; TKA and Tourniquet

Tourniquet limb cuff PROCEDURE

Tourniquet limb cuff and regular anesthesia

TKA and Tourniquet

Intaarticular lidocain DRUG

20 ml of 2% lidocain application intraarticular before surgery (intraarticular lidocain)

Also known as: lidocaine

Intraarticular lidocain

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients knee arthrosis
• Required a surgical treatment with Total Knee Arthroplasty

You may not qualify if:

• Not accept to be in the study
• Not signed consent form
• Not having blood sample for creatinin meassure

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Study Sites (1)

UMAE Dr. Victorio de La Fuente Narvaez

Mexico City, 07020, Mexico

Location

MeSH Terms

Conditions

Acute Kidney Injury; Osteoarthritis, Knee

Interventions

Arthroplasty, Replacement, Knee; Lidocaine

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Avelino Colin Vázquez, MD

  IMSS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Clinical Trial

Study Record Dates

• First Submitted: December 26, 2018
• First Posted: January 8, 2019
• Study Start: March 15, 2018
• Primary Completion: November 20, 2018
• Study Completion: December 20, 2018
• Last Updated: January 9, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)