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

A Comparative Safety and Efficacy Study of Intrathecal Morphine 150 μg with 200 μg Dose for Post-operative Analgesia in Total Knee Replacement Surgeries - IMDATKR

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/05/033462
Enrollment
134
Registered
2021-05-07
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: M170- Bilateral primary osteoarthritis of knee Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Nil: Nil Control Intervention1: Intrathecal Intraoperative anesthesia for Total Knee Replacement: Group A -Inj. Morphine 150 μg Group B - Inj. Morphine 200 μg Either group A or gr

Sponsors

Dr Dipak Desai
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
â?¢ The main outcome variables will be consumption amount of opioids (other than morphine) or Diclofenac or Paracetamol in postoperative periods for analgesia within 24 hours after the operation. Timepoint: Until 24 hour of postoperative periods—

Secondary

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

Countries

India

Contacts

Public ContactDr Dipak Desai

CIMS Hospital Pvt. Ltd.

deepak.desai@cimshospital.org9327015673

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026