Effectiveness of Peri-operative Combined Use of 2 Doses of Dexamethasone With Tranexamic Acid in Lower Limb Joint Replacements-A Randomized Controlled Trial.

NCT06653699 | Completed DMC

• 1 other identifier: IHHN_IRB_2024_02_007
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized controlled clinical trial is to investigate the effectiveness of peri operative use of 2 doses of dexamethasone with tranexamic acid in lower limb replacement, on post operative C-reactive protein (CRP), joint range of motion, fatigue, pain, hospital length of stay in male/female patients undergoing lower limb joint replacement, with pre op Hb above 10g/dL. The main question it aims to answer The peri operative use of 2 doses of dexamethasone with tranexamic acid in lower limb replacement, decrease the post operative CRP, fatigue, pain, hospital length of stay and increase the joint range of motion. Researcher will compare the two groups without knowing which group received either of 1 or 2 doses of Dexamethasone with TXA peri operatively. Patients will do answer the questions mentioned in questionnaire pre operatively, at post op 1st day, at 1st week and 4th week post discharge.

Conditions

Hip Replacement; Knee Replacement

Keywords

dexamethasone; joint replacement; tranexamic acid; lower limb

Outcome Measures

Primary Outcomes (3)

• C-reactive protein

  A c-reactive protein test measures the level of c-reactive protein (CRP) in a sample of blood. CRP is a protein that liver makes. Normally, level of c-reactive protein in blood is low. If the liver releases more CRP into bloodstream indicates inflammation in body. High levels of CRP may mean serious health condition that causes inflammation.

  Will be measure pre operatively, at post operative 1st day

• Post operative pain:

  Postoperative pain is an anticipated and temporary measure. Increase in surgical pain is due to newly created wounds at the skin incision site. It can be measured by numeric pain rating scale including scores 1-10, 1 represents no pain and 10 represents severe pain. It will be measured during rest as well as during weight bearing in this study.

  Will be measure pre operatively, at post operative 1st day, at 1st week after discharge, at 4th week after discharge to the end of treatment at 1 year

• Joint range of motion:

  It can be defined as what is achieved when a force, causes movement of a joint, measured by goniometry in which goniometer is used to measure the range of joint movement.

  Will be measure pre operatively, at post operative 1st day, at 1st week after discharge, at 4th week after discharge

Secondary Outcomes (2)

• Post operative fatigue:

  Will be measure pre operatively, at post operative 1st day, at 1st week after discharge, at 4th week after discharge

• Length of hospital stay:

  Will be measure at 1st week after discharge

Study Arms (2)

GROUP A

EXPERIMENTAL

GROUP A will receive 1 dose of dexamethasone (10mg) with tranexamic acid (20mg/kg), peri operatively

Drug: 1 DOSE OF DEXAMETHASONE AND TRANEXAMIC ACID

GROUP B

EXPERIMENTAL

GROUP B will receive 2 doses of dexamethasone (10mg) with tranexamic acid (20mg/kg), peri operatively

Drug: 2 DOSES OF DEXAMETHASONE AND TRANEXAMIC ACID

Interventions

2 DOSES OF DEXAMETHASONE AND TRANEXAMIC ACID DRUG

In group B, 2 doses of 10 mg intravenous dexamethasone and 20mg/kg of intravenous tranexamic acid administered.

GROUP B

1 DOSE OF DEXAMETHASONE AND TRANEXAMIC ACID DRUG

In group A, 1 dose of 10 mg of intravenous dexamethasone and 20mg/kg of intravenous tranexamic acid administered.

GROUP A

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for unilateral or bilateral total joint replacement surgery in grade 4 osteoarthritis.
• Patients having pre-operative hemoglobin above 10g/dL.
• Include both genders.
• Patients having age more than 45 years.

You may not qualify if:

• Patients having history of thromboembolic event.
• Patients having tranexamic and steroidal allergy.
• Patients having pre operative Hemoglobin level less than 10g/dL
• Patients having history of clotting disorders including abnormal prothrombin time, prothrombin time test, or international normalized ratio.

Sponsors & Collaborators

• Indus Hospital and Health Network: lead

Study Sites (1)

Indus Hospital & Health Network

Lahore, Punjab Province, 54840, Pakistan

Location

MeSH Terms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Zaib Un Nisa, MS IN MSK PHYSIOTHERAPY

  Indus Hospital and Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The randomization assignments were placed into sequentially numbered opaque sealed envelopes, which Will be kept by a certificated research Physiotherapist. The envelope will be opened on the day of operation, and the corresponding drug and placebo will be handled by a researcher who will not involve in patient care. The patients, trial participants, anesthesiologists and data collectors will be blinded to allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHYSIOTHERAPIST

Model Details: All patients will randomize into two groups, Group A: 1 dose of IV Dexamethasone 10mg+ tranexamic acid (20 mg/kg); Group B: 2 doses of IV Dexamethasone 10mg+ tranexamic acid 20 mg/kg. In group A, 1 dose of 10 mg of intravenous dexamethasone and 20mg/kg of intravenous tranexamic acid administered at 10 minutes before surgery. In group B, dose of 10 mg of intravenous dexamethasone and 20mg/kg of intravenous tranexamic acid administered at 10 minutes before surgery and then 10mg of intravenous dexamethasone will be again administered before incision closure.

Study Record Dates

• First Submitted: October 5, 2024
• First Posted: October 22, 2024
• Study Start: July 11, 2024
• Primary Completion: July 3, 2025
• Study Completion: July 20, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: After the publication of article, for 6 months
• Access Criteria: THOSE WHO WILL DOWNLOAD OR READ THE ARTICLE.

Locations

PA (1)