Protocol Title

A Comparative Safety and Efficacy Study of Intrathecal Morphine 150 μg with 200  Î¼g  Dose for Post-operative Analgesia in Total Knee Replacement Surgeries

Protocol Short Title

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

Acronym

IMDATKR

Protocol Number

CIMS/2021/001

Phase of Development

Investigator Initiated Study

Indication

Use of Morphine in Orthopedic Surgeries like Total Knee Replacement Surgeries as analgesics agent

Name of Investigational Product

Morphine 150 μg  or Morphine 200 μg  

Study Rationale

Total knee replacement (TKR) is a successful surgical approach for the treatment of end-stage knee osteoarthritis in terms of functional recovery and pain relief. This clinical study is designed to compare the intraoperative and postoperative hemodynamic effects, the side effects, the effect on the duration of pain start, the 24-hour VAS and the amount of the morphine, additional analgesia used/added to the local anesthetic in the spinal anesthesia  in cases of elective total knee replacement.

Study Objectives

To determine the safety and efficacy of intrathecal Morphine opiate (narcotic) analgesic agent150 vs 200  Î¼g dose  along with other nonsteroidal anti-inflammatory drugs  (NSAIDS) agents

Study Population

The population will consist of approximately 134 males and females with elective primary unilateral TKR

Study Design

This is an interventional, prospective  single-center study to evaluate the safety and efficacy of 2 doses of intrathecal morphine 150 and 200  Î¼g with other nonsteroidal anti-inflammatory drugs  (NSAIDS) agent

Planned No. of Subject

Total 134 Subjects; 67 in Morphine 150 μg  arm and other 67 in Morphine 200  Î¼g  as a comparative arm

Planned Duration of Study Participation

Till hospitalization of subjects for TKR surgeries

Inclusion Criteria

·         Elective primary unilateral TKR;

·         Patient between the age of 40 to 80

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

·         BMI less than 40 kg/m²;

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

Exclusion Criteria

• Patients with the history of severe renal and hepatic dysfunction;
• Contraindication to spinal anesthesia (refusal, coagulopathy, sepsis, local infection, spinal defects, previous laminectomy);
• Contraindication to nonsteroidal anti-inflammatory drugs (NSAIDS);
• Patient has an emotional or neurological condition that would prevent their willingness to participate in the study.
• Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive study treatment
• Creatinine clearance less than 50 ml/min
• Participation in any other clinical trial of an experimental treatment for TKR

Study Treatment

Group A -Inj. Morphine 150 μg intrathecal with saline along with Inj. Sensorcaine 0.5% heavy (4 ml) (20 mg) intrathecal for Intraoperative anesthesia.

Group B - Inj. Morphine 200 μg   intrathecal with saline along with Inj. Sensorcaine 0.5%  heavy (4 ml) (20 mg) intrathecal for Intraoperative anesthesia.

Data Analysis

Descriptive summary statistics (mean, median, standard deviation, minimum and maximum for continuous variables and frequency and percentage for categorical variables)

Conducted At

Care Institute of Medical Sciences (CIMS Hospital Pvt. Ltd.),

Nr. Shukan Mall, Off Science city Road, Sola, Ahmedabad-380060

Principal Investigator

Dr. Deepak Desai

Co- Investigator

Dr. Satish Patel

Dr. Mayank Patel

Dr. Chintan Parekh

Dr. Sandeep Makani

Dr. Mitul Patel

Dr. Ravi Adatiya

Estimated Duration

1 Year