Safety and efficacy of Intrathecal Morphine as an Analgesic in Post-operative Total Knee Replacement

Not Applicable

• Conditions: Health Condition 1: M170- Bilateral primary osteoarthritis of kneeHealth Condition 2: O- Medical and Surgical

• Registration Number: CTRI/2021/05/033462
• Lead Sponsor: Dr Dipak Desai

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Elective primary unilateral TKR;

2.Patient between the age of 40 to 80

3.American Society of Anesthesiologists (ASA) physical status classification 1-3

4.BMI less than 40 kg/m2;

5.Willing and able to provide written informed consent prior to performing study procedures.

Exclusion Criteria

1.Patients with the history of severe renal and hepatic dysfunction;

2.Contraindication to spinal anesthesia (refusal, coagulopathy, sepsis, local infection, spinal

defects, previous laminectomy);

3.Contraindication to nonsteroidal antiinflammatory drugs (NSAIDS);

4.Patient has an emotional or neurological condition that would prevent their willingness to

participate in the study.

5.Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive study treatment

6.Creatinine clearance less than 50 ml/min

7.Participation in any other clinical trial of an experimental treatment for TKR

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
â?¢The main outcome <br/ ><br> variables will be <br/ ><br> consumption amount <br/ ><br> of opioids (other <br/ ><br> than morphine) or <br/ ><br> Diclofenac or <br/ ><br> Paracetamol in <br/ ><br> postoperative <br/ ><br> periods for <br/ ><br> analgesia within 24 <br/ ><br> hours after the <br/ ><br> operation. <br/ ><br> <br/ ><br>Timepoint: Until 24 hour of postoperative periods

Secondary Outcome Measures

Name	Time	Method
1. The side effects between group, the length of hospital stay, range of movement, loss of blood collected in dressing / closed suctions. <br/ ><br>2. The side effect of intrathecal morphine include nausea, vomiting, retention of urine, itching, constipation, sedation, intraoperative discomfort and respiratory depression. <br/ ><br>Timepoint: Until 24 hour of postoperative periods