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CTRI Number  CTRI/2024/06/068299 [Registered on: 04/06/2024] Trial Registered Prospectively
Last Modified On: 30/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of low-dose intrathecal (within the spinal space) morphine as a part of multimodal analgesia (which combines various groups of medications for pain relief) in patients aged 18 to 65 years undergoing cardiac surgery by cutting of breast bone. 
Scientific Title of Study   Effect of low dose intrathecal morphine as a part of multimodal analgesia in patients undergoing cardiac surgeries through sternotomy – open-label randomized control trial. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anil Gupta 
Designation  DM Cardiac anesthesia resident 
Affiliation  All India Institute of Medical Sciences  
Address  Department of Anesthesiology AIIMS Raipur
Great Eastern Road Tatibandh
Raipur
CHHATTISGARH
492099
India 
Phone  9406090235  
Fax    
Email  aneelgoopta@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof. (Dr) Subrata Kumar Singha 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences  
Address  Department of Anesthesiology AIIMS Raipur
Great Eastern Road Tatibandh
Raipur
CHHATTISGARH
492099
India 
Phone  9406090235  
Fax    
Email  subratsingh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Anil Gupta 
Designation  DM Cardiac anesthesia resident 
Affiliation  All India Institute of Medical Sciences  
Address  Department of Anesthesiology AIIMS Raipur
Great Eastern Road Tatibandh
Raipur
CHHATTISGARH
492099
India 
Phone  9406090235  
Fax    
Email  aneelgoopta@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Raipur, Chhattisgarh, India, Pin code- 492099 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences  
Address  AIIMS Raipur, Great Eastern Road, Tatibandh, Raipur, Chhattisgarh, India, Pin Code- 492099  
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anil Gupta  All India Institute of Medical Sciences Raipur  Department of Anesthesiology, 4th floor, CTVS OT and ICU
Raipur
CHHATTISGARH 		 9406090235

aneelgoopta@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, All India Institute of Medical Sciences, Raipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I39||Endocarditis and heart valve disorders in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  INTRATHECAL MORPHINE  Single shot intrathecal 0.1 mg preservative free morphine will be given via 25 gauge Quincke needle either in the L2-L3 or L3-L4 intrathecal space by a midline approach just before induction of anesthesia. They also receive standard treatment i.e., after skin closure USG guided bilateral pectoral intercostal facial plane block (PIFB) will be given using injection 0.25% bupivacaine 20ml and 5 ml of same drug will be infiltrated at drain site. Before extubation, all the patients will receive intravenous paracetamol 1gm followed by 8 hourly during 1st 24 hours of ICU stay. 
Comparator Agent  Routine post-operative analgesia   Only standard treatment i.e., after skin closure USG guided bilateral pectoral intercostal facial plane block (PIFB) will be given using injection 0.25% bupivacaine 20ml and 5 ml of same drug will be infiltrated at drain site. Before extubation, all the patients will receive intravenous paracetamol 1gm followed by 8 hourly during 1st 24 hours of ICU stay. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients aged 18 to 65 years undergoing midline sternotomy for cardiac surgeries, New York Heart Association grade II-III patients 
 
ExclusionCriteria 
Details  Patient refusal to consent, contraindications to intrathecal analgesia such as infection at the injection site, coagulopathy,
and allergy to morphine, pre-existing chronic pain: taking routine analgesics, patients with a history of chronic opiate abuse, patients with psychiatric disorders, patients with previous surgery in thoracic vertebral region, preexisting neurological condition (spinal cord injury, multiple sclerosis, etc.), patients with BMI more than or equal to 35, patients with severe respiratory disease, those expected to be on elective mechanical ventilation for more than 6 hours postoperatively, patients with renal dysfunction (Serum creatinine more than 1.5 mg/dl). 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess postoperative pain by visual analogue scale (VAS) score  upto 24 hour post-operative period 
 
Secondary Outcome  
Outcome  TimePoints 
Total dose of opioids received in the postoperative period (at first 24 hour)  upto 24 hour post-operative period 
Time taken for the first dose of rescue analgesia  in first 24 hour post-operative period 
To evaluate the incidence of any side effects such as respiratory depression, nausea and vomiting, pruritus, incidence of reintubation and sedation   upto 24 hour post-operative period 
 
Target Sample Size   Total Sample Size="104"
Sample Size from India="104" 
Final Enrollment numbers achieved (Total)= "104"
Final Enrollment numbers achieved (India)="104" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   14/06/2024 
Date of Study Completion (India) 30/11/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Not yet published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Title

 

Effect of low dose intrathecal morphine as a part of multimodal analgesia in patients undergoing cardiac surgeries through sternotomy - prospective randomized control trial

Study center

All India Institute of Medical Sciences, Raipur, India

Phase

Randomized Control Trial - Phase 3

Methodology

Single-center, open-label randomized controlled trial

Study duration

1.5 years

Objectives

Primary:

To assess the quality of Analgesia based on VAS pain score in the postoperative period for 24 hours.

Secondary:

To assess the total opioid consumption with rescue analgesia and other associated complications.

Number of subjects

104

Main inclusion and exclusion criteria

Inclusion criteria:

· Patients of age 18 to 65 years undergoing midline sternotomy for cardiac surgeries.

· New York Heart Association grade II-III patients.

Exclusion criteria:

· Patient refusal. · Contraindication to intrathecal analgesia: infection at injection site, coagulopathy, allergy to morphine. · Pre-existing chronic pain: taking routine analgesics. · Patients with a history of chronic opiate abuse. · Patients with psychiatric disorders. · Patients with previous surgery in the thoracic vertebral region. · Preexisting neurological condition (spinal cord injury, multiple sclerosis, etc.). · Patients with BMI more than or equal to 35. · Patients with severe respiratory disease. · Those expected to be on elective mechanical ventilation for >6 hours postoperatively. · Patients with renal dysfunction (Serum creatinine > 1.5 mg/dl).

Intervention

P

Population

Patients aged 18 to 65 years undergoing midline sternotomy for cardiac surgeries

I

Intervention

Intrathecal morphine

C

Control

Standard treatment

O

Outcomes

Postoperative pain by visual analogue scale (VAS) score

 

Outcomes

Primary outcome: To assess postoperative pain by visual analogue scale (VAS) score. Secondary outcome: 1. Total dose of opioids received in the postoperative period (at first 24 hours). 2. Time taken for the first dose of rescue analgesia. 3. To evaluate the incidence of any side effects: Respiratory depression, nausea,   and vomiting, pruritus, the incidence of reintubation, sedation
 
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